- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04375280
Evaluation of Impaired Mobility in Chronic Illness Constitution of a Cohort (EVALMOB)
Descripción general del estudio
Estado
Condiciones
Descripción detallada
We propose to constitute a prospective cohort of subjects carrying chronic disease. The objective is to explore all the different components of mobility (balance, muscle force, body composition, walking ability, metabolism, etc.), to assess their impact on the functional capacity of individuals and to identify their potential interactions. Processing this data could ultimately allow the development of a model to determine a composite standard profile of "dysmobility" in patients with chronic disease.
In the present protocol, parameters will be measured on five occasions (at inclusion, at 6 months from the inclusion day, at 1,2 and 5 year(s) from the inclusion day). All tests will be performed on the same day. New assessments will be done on the same principle as the initial evaluation.
Statistical analyses will be carried out using Stata software (version 13, StataCorp, College Station, USA). Data will be described by frequencies and percentages for categorical variables and by means and standard deviation (or median and interquartile range if data are not normally distributed) for continuous variables. The normality of continuous data will be assessed graphically and using the Shapiro-Wilk test. The main analysis will consist in determining patient profiles regarding their mobility. Clustering-type approaches (supervised or not) will be proposed: k-means, vector machine support, machine learning, factor analysis. For example, factor analyses on mixed data will allow the main components of mobility to be characterized. They can be followed by an ascending hierarchical classification in order to determine homogeneous groups of patients.
These groups will be described and compared on the main criteria evaluated using standard statistical tests: chi2 test (or Fisher's exact test if applicable) for the categorical criteria and using an analysis of variance (or Kruskal-Wallis if data are not normally distributed) for continuous criteria. The main analysis will be broken down more specifically for each of the pathologies considered. In addition, the sensitivity to change will be assessed in each pathology and for each assessment criterion. The search for factors related to the evolution of the different criteria will be carried out using usual tests and mixed multivariate models (logistics for categorical / linear criteria for continuous criteria) considering the subject as a random effect, and adjusting on the time criteria (inclusion / follow-up) and the criteria highlighted in the univariate analyses and in light of the elements reported in the literature. A sensitivity analysis will be proposed in order to study the statistical nature of the missing data and to propose, if necessary, the most suitable method of imputing the data: multiple imputation, maximum bias or LOCF in the case of longitudinal data.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Clermont-Ferrand, Francia, 63003
- Reclutamiento
- CHU Clermont Ferrand
-
Investigador principal:
- Frédéric Costes
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Man or woman aged 18 to 90.
- Patients with chronic pathology contributing to impaired mobility.
- Volunteers who have given their written consent.
- Affiliated to French health care system (for France)
Exclusion Criteria:
- Patients suffering from progressive psychiatric pathologies (active psychosis, hallucinations, etc.) or the presence of another serious unstabilized pathology (decompensated heart failure, progressive terminal cancer, etc.).
- People with poorly controlled or unstable cardiovascular disease.
- Major osteoarticular or neurological problems completely preventing the proper performance of the various tests.
- Non-autonomous patient
- Persons under guardianship, curatorship, deprived of liberty or safeguarding justice.
- People excluded from another study.
- Pregnant or lactating women.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Cohort 1
Participants will be involved in a long-term evaluation program combining, body composition measures, physical tests as well as self-administered questionnaires.
Participants will be followed for 5 years with evaluations taking place at inclusion, 6 months, at 1, 2 and 5 years
|
Firstly, volunteers will be invited to complete online questionnaires on a secure platform. The mobility assessment will be carried out initially (t1) and up to a maximum of 4 times (t1 to t4) as part of a day hospitalization. Questionnaires will be diverse (SF36, KOOS, HOOS, BROCKER, MNA, TAMPA, etc.) in order to assess several aspects that compose mobility. Physical evaluations will include various validated tests (isokinetic strength measure, TUG, 6MWT, Berg Balance Scale, etc.) |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
dismobility score calculated from the results reported in secondary outcomes
Periodo de tiempo: Day 0
|
The main objective being to determine patient profiles with regard to "dysmobility", all the criteria detailed as secondary outcomes will be considered for the definition of the profiles
|
Day 0
|
dismobility score calculated from the results reported in secondary outcomes
Periodo de tiempo: Month 6
|
The main objective being to determine patient profiles with regard to "dysmobility", all the criteria detailed as secondary outcomes will be considered for the definition of the profiles
|
Month 6
|
dismobility score calculated from the results reported in secondary outcomes
Periodo de tiempo: Year 1
|
The main objective being to determine patient profiles with regard to "dysmobility", all the criteria detailed as secondary outcomes will be considered for the definition of the profiles
|
Year 1
|
dismobility score calculated from the results reported in secondary outcomes
Periodo de tiempo: Year 2
|
The main objective being to determine patient profiles with regard to "dysmobility", all the criteria detailed as secondary outcomes will be considered for the definition of the profiles
|
Year 2
|
dismobility score calculated from the results reported in secondary outcomes
Periodo de tiempo: Year 5
|
The main objective being to determine patient profiles with regard to "dysmobility", all the criteria detailed as secondary outcomes will be considered for the definition of the profiles
|
Year 5
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Máxima fuerza isométrica voluntaria de los músculos cuádriceps a 45° (Nm).
Periodo de tiempo: Día 0
|
: La fuerza isométrica voluntaria máxima de los músculos cuádriceps se medirá con el dispositivo HUMA® /NORM™.
|
Día 0
|
Fuerza isocinética voluntaria máxima de los músculos cuádriceps a 240°/s (Nm).
Periodo de tiempo: Día 0
|
La fuerza isocinética voluntaria máxima de los músculos cuádriceps a 240°/s se medirá con el dispositivo HUMA® /NORM™.
|
Día 0
|
Fuerza isocinética voluntaria máxima de los músculos cuádriceps a 30°/s (contracción excéntrica) (Nm).
Periodo de tiempo: Día 0
|
La fuerza isocinética voluntaria máxima de los músculos cuádriceps a 30°/s se medirá con el dispositivo HUMA® /NORM™.
|
Día 0
|
Fuerza isocinética voluntaria máxima de los isquiotibiales a 60°/s (Nm).
Periodo de tiempo: Día 0
|
La fuerza isocinética voluntaria máxima de los isquiotibiales a 60°/s se medirá con el dispositivo HUMA® /NORM™.
|
Día 0
|
Fuerza isocinética voluntaria máxima de los isquiotibiales a 30°/s (contracción excéntrica) (Nm).
Periodo de tiempo: Día 0
|
La fuerza isocinética voluntaria máxima de los isquiotibiales a 30°/s se medirá con el dispositivo HUMA® /NORM™.
|
Día 0
|
Deflexión máxima (adelante, atrás izquierda y derecha).
Periodo de tiempo: Día 0
|
La deflexión máxima se medirá con la plataforma de posturografía estática STATIPRO®.
|
Día 0
|
The main objective being to determine patient profiles with regard to "dysmobility", all the criteria detailed as secondary outcomes will be considered for the definition of the profiles
Periodo de tiempo: Day 0
|
Demographics information will be obtained using a single questionnaire including questions on age, gender, qualification, personal work status, ethnicity, life and occupational events.
|
Day 0
|
Weight (Kg).
Periodo de tiempo: Day 0
|
Weight will be measured with the medical body weight scale SECA® and according to the ISAK recommendations.
|
Day 0
|
Weight (Kg).
Periodo de tiempo: Month 6
|
Weight will be measured with the medical body weight scale SECA® and according to the ISAK recommendations.
|
Month 6
|
Weight (Kg).
Periodo de tiempo: Year 1
|
Weight will be measured with the medical body weight scale SECA® and according to the ISAK recommendations.
|
Year 1
|
Weight (Kg).
Periodo de tiempo: Year 2
|
Weight will be measured with the medical body weight scale SECA® and according to the ISAK recommendations.
|
Year 2
|
Weight (Kg).
Periodo de tiempo: Year 5
|
Weight will be measured with the medical body weight scale SECA® and according to the ISAK recommendations.
|
Year 5
|
Height (cm).
Periodo de tiempo: Day 0
|
Height will be measured with a wall mounted tape measure and according to the ISAK recommendations
|
Day 0
|
Height (cm).
Periodo de tiempo: Month 6
|
Height will be measured with a wall mounted tape measure and according to the ISAK recommendations
|
Month 6
|
Height (cm).
Periodo de tiempo: Year 1
|
Height will be measured with a wall mounted tape measure and according to the ISAK recommendations
|
Year 1
|
Height (cm).
Periodo de tiempo: Year 2
|
Height will be measured with a wall mounted tape measure and according to the ISAK recommendations
|
Year 2
|
Height (cm).
Periodo de tiempo: Year 5
|
Height will be measured with a wall mounted tape measure and according to the ISAK recommendations
|
Year 5
|
Body fat percentage (%).
Periodo de tiempo: Day 0
|
Body fat percentage will be measured with the Harpenden skinfold caliper by measuring skinfold thickness in four different sites (triceps; biceps, suprailiac, subscapular).
|
Day 0
|
Body fat percentage (%).
Periodo de tiempo: Month 6
|
Body fat percentage will be measured with the Harpenden skinfold caliper by measuring skinfold thickness in four different sites (triceps; biceps, suprailiac, subscapular).
|
Month 6
|
Body fat percentage (%).
Periodo de tiempo: Year 1
|
Body fat percentage will be measured with the Harpenden skinfold caliper by measuring skinfold thickness in four different sites (triceps; biceps, suprailiac, subscapular).
|
Year 1
|
Body fat percentage (%).
Periodo de tiempo: Year 2
|
Body fat percentage will be measured with the Harpenden skinfold caliper by measuring skinfold thickness in four different sites (triceps; biceps, suprailiac, subscapular).
|
Year 2
|
Body fat percentage (%).
Periodo de tiempo: Year 5
|
Body fat percentage will be measured with the Harpenden skinfold caliper by measuring skinfold thickness in four different sites (triceps; biceps, suprailiac, subscapular).
|
Year 5
|
Waist circumference (cm).
Periodo de tiempo: Day 0
|
Waist circumference will be measured with a medical body tape measure and according to the ISAK recommendations
|
Day 0
|
Waist circumference (cm).
Periodo de tiempo: Month 5
|
Waist circumference will be measured with a medical body tape measure and according to the ISAK recommendations
|
Month 5
|
Waist circumference (cm).
Periodo de tiempo: Year 1
|
Waist circumference will be measured with a medical body tape measure and according to the ISAK recommendations
|
Year 1
|
Waist circumference (cm).
Periodo de tiempo: Year 2
|
Waist circumference will be measured with a medical body tape measure and according to the ISAK recommendations
|
Year 2
|
Waist circumference (cm).
Periodo de tiempo: Year 5
|
Waist circumference will be measured with a medical body tape measure and according to the ISAK recommendations
|
Year 5
|
Hip circumference (cm).
Periodo de tiempo: Day 0
|
Hip circumference will be measured with a medical body tape measure and according to the ISAK recommendations.
|
Day 0
|
Hip circumference (cm).
Periodo de tiempo: Month 6
|
Hip circumference will be measured with a medical body tape measure and according to the ISAK recommendations.
|
Month 6
|
Hip circumference (cm).
Periodo de tiempo: Year 1
|
Hip circumference will be measured with a medical body tape measure and according to the ISAK recommendations.
|
Year 1
|
Hip circumference (cm).
Periodo de tiempo: Year 2
|
Hip circumference will be measured with a medical body tape measure and according to the ISAK recommendations.
|
Year 2
|
Hip circumference (cm).
Periodo de tiempo: Year 5
|
Hip circumference will be measured with a medical body tape measure and according to the ISAK recommendations.
|
Year 5
|
Brachial circumference (cm).
Periodo de tiempo: Day 0
|
Brachial circumference will be measured with a medical body tape measure and according to the ISAK recommendations.
|
Day 0
|
Brachial circumference (cm).
Periodo de tiempo: Month 6
|
Brachial circumference will be measured with a medical body tape measure and according to the ISAK recommendations.
|
Month 6
|
Brachial circumference (cm).
Periodo de tiempo: Year 1
|
Brachial circumference will be measured with a medical body tape measure and according to the ISAK recommendations.
|
Year 1
|
Brachial circumference (cm).
Periodo de tiempo: Year 2
|
Brachial circumference will be measured with a medical body tape measure and according to the ISAK recommendations.
|
Year 2
|
Brachial circumference (cm).
Periodo de tiempo: Year 5
|
Brachial circumference will be measured with a medical body tape measure and according to the ISAK recommendations.
|
Year 5
|
Calf circumference (cm).
Periodo de tiempo: Day 0
|
Calf circumference will be measured with a medical body tape measure and according to the ISAK recommendations
|
Day 0
|
Calf circumference (cm).
Periodo de tiempo: Month 6
|
Calf circumference will be measured with a medical body tape measure and according to the ISAK recommendations
|
Month 6
|
Calf circumference (cm).
Periodo de tiempo: Year 1
|
Calf circumference will be measured with a medical body tape measure and according to the ISAK recommendations
|
Year 1
|
Calf circumference (cm).
Periodo de tiempo: Year 2
|
Calf circumference will be measured with a medical body tape measure and according to the ISAK recommendations
|
Year 2
|
Calf circumference (cm).
Periodo de tiempo: Year 5
|
Calf circumference will be measured with a medical body tape measure and according to the ISAK recommendations
|
Year 5
|
Body Mass Index (Kg/m²).
Periodo de tiempo: Day 0
|
BMI will be calculated (weight in kilograms divided by height in meters squared).
|
Day 0
|
Body Mass Index (Kg/m²).
Periodo de tiempo: Month 6
|
BMI will be calculated (weight in kilograms divided by height in meters squared).
|
Month 6
|
Body Mass Index (Kg/m²).
Periodo de tiempo: Year 1
|
BMI will be calculated (weight in kilograms divided by height in meters squared).
|
Year 1
|
Body Mass Index (Kg/m²).
Periodo de tiempo: Year 2
|
BMI will be calculated (weight in kilograms divided by height in meters squared).
|
Year 2
|
Body Mass Index (Kg/m²).
Periodo de tiempo: Year 5
|
BMI will be calculated (weight in kilograms divided by height in meters squared).
|
Year 5
|
Body composition
Periodo de tiempo: Day 0
|
Body composition (muscle and fat) will be measured using he Bodystat® Impedance-meter.
|
Day 0
|
Body composition
Periodo de tiempo: Month 6
|
Body composition (muscle and fat) will be measured using he Bodystat® Impedance-meter.
|
Month 6
|
Body composition
Periodo de tiempo: Year 1
|
Body composition (muscle and fat) will be measured using he Bodystat® Impedance-meter.
|
Year 1
|
Body composition
Periodo de tiempo: Year 2
|
Body composition (muscle and fat) will be measured using he Bodystat® Impedance-meter.
|
Year 2
|
Body composition
Periodo de tiempo: Year 5
|
Body composition (muscle and fat) will be measured using he Bodystat® Impedance-meter.
|
Year 5
|
T-score (DS).
Periodo de tiempo: DAy 0
|
- Description: T-score will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.
|
DAy 0
|
T-score (DS).
Periodo de tiempo: Month 6
|
- Description: T-score will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.
|
Month 6
|
T-score (DS).
Periodo de tiempo: Year 1
|
- Description: T-score will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.
|
Year 1
|
T-score (DS).
Periodo de tiempo: Year 2
|
- Description: T-score will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.
|
Year 2
|
T-score (DS).
Periodo de tiempo: Year 5
|
- Description: T-score will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.
|
Year 5
|
Z-score (DS).
Periodo de tiempo: Day 0
|
Z-score will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer
|
Day 0
|
Z-score (DS).
Periodo de tiempo: Month 6
|
Z-score will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer
|
Month 6
|
Z-score (DS).
Periodo de tiempo: Year 1
|
Z-score will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer
|
Year 1
|
Z-score (DS).
Periodo de tiempo: Year 2
|
Z-score will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer
|
Year 2
|
Z-score (DS).
Periodo de tiempo: Year 5
|
Z-score will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer
|
Year 5
|
Fat mass
Periodo de tiempo: Day 0
|
Fat mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.
|
Day 0
|
Fat mass
Periodo de tiempo: Month 6
|
Fat mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.
|
Month 6
|
Fat mass
Periodo de tiempo: Year 1
|
Fat mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.
|
Year 1
|
Fat mass
Periodo de tiempo: Year 2
|
Fat mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.
|
Year 2
|
Fat mass
Periodo de tiempo: Year 5
|
Fat mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.
|
Year 5
|
Fat-free mass (%).
Periodo de tiempo: Day 0
|
: Fat free mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.
|
Day 0
|
Fat-free mass (%).
Periodo de tiempo: Month 6
|
: Fat free mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.
|
Month 6
|
Fat-free mass (%).
Periodo de tiempo: Year 1
|
: Fat free mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.
|
Year 1
|
Fat-free mass (%).
Periodo de tiempo: Year 2
|
: Fat free mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.
|
Year 2
|
Fat-free mass (%).
Periodo de tiempo: Year 5
|
: Fat free mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.
|
Year 5
|
Fat mas index (Kg/m²).
Periodo de tiempo: Day 0
|
Fat mas index will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.
|
Day 0
|
Fat mas index (Kg/m²).
Periodo de tiempo: Month 6
|
Fat mas index will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.
|
Month 6
|
Fat mas index (Kg/m²).
Periodo de tiempo: Year 1
|
Fat mas index will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.
|
Year 1
|
Fat mas index (Kg/m²).
Periodo de tiempo: Year 2
|
Fat mas index will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.
|
Year 2
|
Fat mas index (Kg/m²).
Periodo de tiempo: Year 5
|
Fat mas index will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.
|
Year 5
|
Ratio of android to gynoid fat mass.
Periodo de tiempo: Day 0
|
Ratio of android to gynoid fat mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer
|
Day 0
|
Ratio of android to gynoid fat mass.
Periodo de tiempo: Month 6
|
Ratio of android to gynoid fat mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer
|
Month 6
|
Ratio of android to gynoid fat mass.
Periodo de tiempo: Year 1
|
Ratio of android to gynoid fat mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer
|
Year 1
|
Ratio of android to gynoid fat mass.
Periodo de tiempo: Year 2
|
Ratio of android to gynoid fat mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer
|
Year 2
|
Ratio of android to gynoid fat mass.
Periodo de tiempo: Year 5
|
Ratio of android to gynoid fat mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer
|
Year 5
|
Visceral adipose tissue (Kg).
Periodo de tiempo: Day 0
|
Visceral fat mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.
|
Day 0
|
Visceral adipose tissue (Kg).
Periodo de tiempo: Month 6
|
Visceral fat mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.
|
Month 6
|
Visceral adipose tissue (Kg).
Periodo de tiempo: Year 1
|
Visceral fat mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.
|
Year 1
|
Visceral adipose tissue (Kg).
Periodo de tiempo: Year 2
|
Visceral fat mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.
|
Year 2
|
Visceral adipose tissue (Kg).
Periodo de tiempo: Year 5
|
Visceral fat mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.
|
Year 5
|
Fat-free mass index (kg/m²).
Periodo de tiempo: Day 0
|
: Fat-free mass index will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.
|
Day 0
|
Fat-free mass index (kg/m²).
Periodo de tiempo: Month 6
|
: Fat-free mass index will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.
|
Month 6
|
Fat-free mass index (kg/m²).
Periodo de tiempo: Year 1
|
: Fat-free mass index will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.
|
Year 1
|
Fat-free mass index (kg/m²).
Periodo de tiempo: Year 2
|
: Fat-free mass index will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.
|
Year 2
|
Fat-free mass index (kg/m²).
Periodo de tiempo: Year 5
|
: Fat-free mass index will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.
|
Year 5
|
Appendicular fat-free mass index (Kg/m²).
Periodo de tiempo: Day 0
|
Appendicular fat-free mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.
|
Day 0
|
Appendicular fat-free mass index (Kg/m²).
Periodo de tiempo: Month 6
|
Appendicular fat-free mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.
|
Month 6
|
Appendicular fat-free mass index (Kg/m²).
Periodo de tiempo: Year 1
|
Appendicular fat-free mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.
|
Year 1
|
Appendicular fat-free mass index (Kg/m²).
Periodo de tiempo: Year 2
|
Appendicular fat-free mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.
|
Year 2
|
Appendicular fat-free mass index (Kg/m²).
Periodo de tiempo: Year 5
|
Appendicular fat-free mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.
|
Year 5
|
Bone mass (Kg)
Periodo de tiempo: Day 0
|
- Description: Bone mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.
|
Day 0
|
Bone mass (Kg)
Periodo de tiempo: Month 6
|
- Description: Bone mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.
|
Month 6
|
Bone mass (Kg)
Periodo de tiempo: Year 1
|
- Description: Bone mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.
|
Year 1
|
Bone mass (Kg)
Periodo de tiempo: Year 2
|
- Description: Bone mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.
|
Year 2
|
Bone mass (Kg)
Periodo de tiempo: Year 5
|
- Description: Bone mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.
|
Year 5
|
Daily caloric intake (Kcal/24h).
Periodo de tiempo: Day 0
|
Daily caloric intake will be estimated with a 24-hour (all foods and beverages consumed by the respondent in the past 24 hours).
|
Day 0
|
Daily caloric intake (Kcal/24h).
Periodo de tiempo: Month 6
|
Daily caloric intake will be estimated with a 24-hour (all foods and beverages consumed by the respondent in the past 24 hours).
|
Month 6
|
Daily caloric intake (Kcal/24h).
Periodo de tiempo: Year 1
|
Daily caloric intake will be estimated with a 24-hour (all foods and beverages consumed by the respondent in the past 24 hours).
|
Year 1
|
Daily caloric intake (Kcal/24h).
Periodo de tiempo: Year 2
|
Daily caloric intake will be estimated with a 24-hour (all foods and beverages consumed by the respondent in the past 24 hours).
|
Year 2
|
Daily caloric intake (Kcal/24h).
Periodo de tiempo: Year 5
|
Daily caloric intake will be estimated with a 24-hour (all foods and beverages consumed by the respondent in the past 24 hours).
|
Year 5
|
Daily protein intake (in g and as a percentage of total caloric intake).
Periodo de tiempo: Day 0
|
Daily protein intake will be estimated with a 24-hour (all foods and beverages consumed by the respondent in the past 24 hours).
|
Day 0
|
Daily protein intake (in g and as a percentage of total caloric intake).
Periodo de tiempo: Month 6
|
Daily protein intake (in g and as a percentage of total caloric intake).
|
Month 6
|
Daily protein intake (in g and as a percentage of total caloric intake).
Periodo de tiempo: Year 1
|
Daily protein intake will be estimated with a 24-hour (all foods and beverages consumed by the respondent in the past 24 hours).
|
Year 1
|
Daily protein intake (in g and as a percentage of total caloric intake).
Periodo de tiempo: Year 2
|
Daily protein intake will be estimated with a 24-hour (all foods and beverages consumed by the respondent in the past 24 hours).
|
Year 2
|
Daily protein intake (in g and as a percentage of total caloric intake).
Periodo de tiempo: Year 5
|
Daily protein intake will be estimated with a 24-hour (all foods and beverages consumed by the respondent in the past 24 hours).
|
Year 5
|
Daily carbohydrate intake (in g and as a percentage of total caloric intake).
Periodo de tiempo: Day 0
|
Daily carbohydrate intake will be estimated with a 24-hour (all foods and beverages consumed by the respondent in the past 24 hours).
|
Day 0
|
Daily carbohydrate intake (in g and as a percentage of total caloric intake).
Periodo de tiempo: Month 6
|
Daily carbohydrate intake will be estimated with a 24-hour (all foods and beverages consumed by the respondent in the past 24 hours).
|
Month 6
|
Daily carbohydrate intake (in g and as a percentage of total caloric intake).
Periodo de tiempo: Year 1
|
Daily carbohydrate intake will be estimated with a 24-hour (all foods and beverages consumed by the respondent in the past 24 hours).
|
Year 1
|
Daily carbohydrate intake (in g and as a percentage of total caloric intake).
Periodo de tiempo: Year 2
|
Daily carbohydrate intake will be estimated with a 24-hour (all foods and beverages consumed by the respondent in the past 24 hours).
|
Year 2
|
Daily carbohydrate intake (in g and as a percentage of total caloric intake).
Periodo de tiempo: Year 5
|
Daily carbohydrate intake will be estimated with a 24-hour (all foods and beverages consumed by the respondent in the past 24 hours).
|
Year 5
|
Daily fat intake (in g and as a percentage of total caloric intake).
Periodo de tiempo: Day 0
|
Daily fat intake will be estimated with a 24-hour (all foods and beverages consumed by the respondent in the past 24 hours).
|
Day 0
|
Daily fat intake (in g and as a percentage of total caloric intake).
Periodo de tiempo: Month 6
|
Daily fat intake will be estimated with a 24-hour (all foods and beverages consumed by the respondent in the past 24 hours).
|
Month 6
|
Daily fat intake (in g and as a percentage of total caloric intake).
Periodo de tiempo: Year 1
|
Daily fat intake will be estimated with a 24-hour (all foods and beverages consumed by the respondent in the past 24 hours).
|
Year 1
|
Daily fat intake (in g and as a percentage of total caloric intake).
Periodo de tiempo: Year 2
|
Daily fat intake will be estimated with a 24-hour (all foods and beverages consumed by the respondent in the past 24 hours).
|
Year 2
|
Daily fat intake (in g and as a percentage of total caloric intake).
Periodo de tiempo: Year 5
|
Daily fat intake will be estimated with a 24-hour (all foods and beverages consumed by the respondent in the past 24 hours).
|
Year 5
|
Nutritional status assessment
Periodo de tiempo: Day 0
|
Nutritional status assessment will be assessed with the Mini Nutritional Assessment Questionnaire.
|
Day 0
|
Nutritional status assessment
Periodo de tiempo: Month 6
|
Nutritional status assessment will be assessed with the Mini Nutritional Assessment Questionnaire.
|
Month 6
|
Nutritional status assessment
Periodo de tiempo: Year 1
|
Nutritional status assessment will be assessed with the Mini Nutritional Assessment Questionnaire.
|
Year 1
|
Nutritional status assessment
Periodo de tiempo: Year 2
|
Nutritional status assessment will be assessed with the Mini Nutritional Assessment Questionnaire.
|
Year 2
|
Nutritional status assessment
Periodo de tiempo: Year 5
|
Nutritional status assessment will be assessed with the Mini Nutritional Assessment Questionnaire.
|
Year 5
|
Risk of undernutrition.
Periodo de tiempo: Day 0
|
Risk of undernutrition will be assessed with the Brocker Questionnaire
|
Day 0
|
Risk of undernutrition.
Periodo de tiempo: Month 6
|
Risk of undernutrition will be assessed with the Brocker Questionnaire
|
Month 6
|
Risk of undernutrition.
Periodo de tiempo: Year 1
|
Risk of undernutrition will be assessed with the Brocker Questionnaire
|
Year 1
|
Risk of undernutrition.
Periodo de tiempo: Year 2
|
Risk of undernutrition will be assessed with the Brocker Questionnaire
|
Year 2
|
Risk of undernutrition.
Periodo de tiempo: Year 5
|
Risk of undernutrition will be assessed with the Brocker Questionnaire
|
Year 5
|
Basic biology.
Periodo de tiempo: Day 0
|
: Basic biology will be measured using endocrine assays (fasting blood glucose, HbA1c, HDL-c and LDL-c, TG, CPK)
|
Day 0
|
Basic biology.
Periodo de tiempo: Month 6
|
: Basic biology will be measured using endocrine assays (fasting blood glucose, HbA1c, HDL-c and LDL-c, TG, CPK)
|
Month 6
|
Basic biology.
Periodo de tiempo: Year 1
|
: Basic biology will be measured using endocrine assays (fasting blood glucose, HbA1c, HDL-c and LDL-c, TG, CPK)
|
Year 1
|
Basic biology.
Periodo de tiempo: Year 2
|
: Basic biology will be measured using endocrine assays (fasting blood glucose, HbA1c, HDL-c and LDL-c, TG, CPK)
|
Year 2
|
Basic biology.
Periodo de tiempo: Year 5
|
: Basic biology will be measured using endocrine assays (fasting blood glucose, HbA1c, HDL-c and LDL-c, TG, CPK)
|
Year 5
|
Maximum voluntary isometric strength of the quadriceps muscles at 45° (Nm).
Periodo de tiempo: Month 6
|
: Maximum voluntary isometric strength of the quadriceps muscles will be measured with the HUMA® /NORM™ device.
|
Month 6
|
Maximum voluntary isometric strength of the quadriceps muscles at 45° (Nm).
Periodo de tiempo: Year 1
|
: Maximum voluntary isometric strength of the quadriceps muscles will be measured with the HUMA® /NORM™ device.
|
Year 1
|
Maximum voluntary isometric strength of the quadriceps muscles at 45° (Nm).
Periodo de tiempo: Year 2
|
: Maximum voluntary isometric strength of the quadriceps muscles will be measured with the HUMA® /NORM™ device.
|
Year 2
|
Maximum voluntary isometric strength of the quadriceps muscles at 45° (Nm).
Periodo de tiempo: Year 5
|
: Maximum voluntary isometric strength of the quadriceps muscles will be measured with the HUMA® /NORM™ device.
|
Year 5
|
Maximum voluntary isokinetic strength of the quadriceps muscles at 60°/s (Nm).
Periodo de tiempo: Day 0
|
- Description: Maximum voluntary isokinetic strength of the quadriceps muscles at 60°/s will be measured with the HUMA® /NORM™ device.
|
Day 0
|
Maximum voluntary isokinetic strength of the quadriceps muscles at 60°/s (Nm).
Periodo de tiempo: Month 6
|
- Description: Maximum voluntary isokinetic strength of the quadriceps muscles at 60°/s will be measured with the HUMA® /NORM™ device.
|
Month 6
|
Maximum voluntary isokinetic strength of the quadriceps muscles at 60°/s (Nm).
Periodo de tiempo: Year 1
|
- Description: Maximum voluntary isokinetic strength of the quadriceps muscles at 60°/s will be measured with the HUMA® /NORM™ device.
|
Year 1
|
Maximum voluntary isokinetic strength of the quadriceps muscles at 60°/s (Nm).
Periodo de tiempo: Year 2
|
- Description: Maximum voluntary isokinetic strength of the quadriceps muscles at 60°/s will be measured with the HUMA® /NORM™ device.
|
Year 2
|
Maximum voluntary isokinetic strength of the quadriceps muscles at 60°/s (Nm).
Periodo de tiempo: Year 5
|
- Description: Maximum voluntary isokinetic strength of the quadriceps muscles at 60°/s will be measured with the HUMA® /NORM™ device.
|
Year 5
|
Maximum voluntary isokinetic strength of the quadriceps muscles at 240°/s (Nm).
Periodo de tiempo: Month 6
|
Maximum voluntary isokinetic strength of the quadriceps muscles at 240°/s will be measured with the HUMA® /NORM™ device.
|
Month 6
|
Maximum voluntary isokinetic strength of the quadriceps muscles at 240°/s (Nm).
Periodo de tiempo: Year 1
|
Maximum voluntary isokinetic strength of the quadriceps muscles at 240°/s will be measured with the HUMA® /NORM™ device.
|
Year 1
|
Maximum voluntary isokinetic strength of the quadriceps muscles at 240°/s (Nm).
Periodo de tiempo: Year 2
|
Maximum voluntary isokinetic strength of the quadriceps muscles at 240°/s will be measured with the HUMA® /NORM™ device.
|
Year 2
|
Maximum voluntary isokinetic strength of the quadriceps muscles at 240°/s (Nm).
Periodo de tiempo: Year 5
|
Maximum voluntary isokinetic strength of the quadriceps muscles at 240°/s will be measured with the HUMA® /NORM™ device.
|
Year 5
|
Maximum voluntary isokinetic strength of the quadriceps muscles at 30°/s (eccentric contraction) (Nm).
Periodo de tiempo: Month 6
|
Maximum voluntary isokinetic strength of the quadriceps muscles at 30°/s will be measured with the HUMA® /NORM™ device.
|
Month 6
|
Maximum voluntary isokinetic strength of the quadriceps muscles at 30°/s (eccentric contraction) (Nm).
Periodo de tiempo: Year 1
|
Maximum voluntary isokinetic strength of the quadriceps muscles at 30°/s will be measured with the HUMA® /NORM™ device.
|
Year 1
|
Maximum voluntary isokinetic strength of the quadriceps muscles at 30°/s (eccentric contraction) (Nm).
Periodo de tiempo: Year 2
|
Maximum voluntary isokinetic strength of the quadriceps muscles at 30°/s will be measured with the HUMA® /NORM™ device.
|
Year 2
|
Maximum voluntary isokinetic strength of the quadriceps muscles at 30°/s (eccentric contraction) (Nm).
Periodo de tiempo: Year 5
|
Maximum voluntary isokinetic strength of the quadriceps muscles at 30°/s will be measured with the HUMA® /NORM™ device.
|
Year 5
|
Maximum voluntary isokinetic strength of the hamstring muscles at 60°/s (Nm).
Periodo de tiempo: Month 6
|
Maximum voluntary isokinetic strength of the hamstring muscles at 60°/s will be measured with the HUMA® /NORM™ device.
|
Month 6
|
Maximum voluntary isokinetic strength of the hamstring muscles at 60°/s (Nm).
Periodo de tiempo: Year 1
|
Maximum voluntary isokinetic strength of the hamstring muscles at 60°/s will be measured with the HUMA® /NORM™ device.
|
Year 1
|
Maximum voluntary isokinetic strength of the hamstring muscles at 60°/s (Nm).
Periodo de tiempo: Year 2
|
Maximum voluntary isokinetic strength of the hamstring muscles at 60°/s will be measured with the HUMA® /NORM™ device.
|
Year 2
|
Maximum voluntary isokinetic strength of the hamstring muscles at 60°/s (Nm).
Periodo de tiempo: Year 5
|
Maximum voluntary isokinetic strength of the hamstring muscles at 60°/s will be measured with the HUMA® /NORM™ device.
|
Year 5
|
Maximum voluntary isokinetic strength of the hamstring muscles at 240°/s (Nm).
Periodo de tiempo: Day 0
|
- Description: Maximum voluntary isokinetic strength of the hamstring muscles at 240°/s will be measured with the HUMA® /NORM™ device.
|
Day 0
|
Maximum voluntary isokinetic strength of the hamstring muscles at 240°/s (Nm).
Periodo de tiempo: Month 6
|
- Description: Maximum voluntary isokinetic strength of the hamstring muscles at 240°/s will be measured with the HUMA® /NORM™ device.
|
Month 6
|
Maximum voluntary isokinetic strength of the hamstring muscles at 240°/s (Nm).
Periodo de tiempo: Year 1
|
- Description: Maximum voluntary isokinetic strength of the hamstring muscles at 240°/s will be measured with the HUMA® /NORM™ device.
|
Year 1
|
Maximum voluntary isokinetic strength of the hamstring muscles at 240°/s (Nm).
Periodo de tiempo: Year 2
|
- Description: Maximum voluntary isokinetic strength of the hamstring muscles at 240°/s will be measured with the HUMA® /NORM™ device.
|
Year 2
|
Maximum voluntary isokinetic strength of the hamstring muscles at 240°/s (Nm).
Periodo de tiempo: Year 5
|
- Description: Maximum voluntary isokinetic strength of the hamstring muscles at 240°/s will be measured with the HUMA® /NORM™ device.
|
Year 5
|
Maximum voluntary isokinetic strength of the hamstring muscles at 30°/s (eccentric contraction) (Nm).
Periodo de tiempo: Month 6
|
Maximum voluntary isokinetic strength of the hamstring muscles at 30°/s will be measured with the HUMA® /NORM™ device.
|
Month 6
|
Maximum voluntary isokinetic strength of the hamstring muscles at 30°/s (eccentric contraction) (Nm).
Periodo de tiempo: Year 1
|
Maximum voluntary isokinetic strength of the hamstring muscles at 30°/s will be measured with the HUMA® /NORM™ device.
|
Year 1
|
Maximum voluntary isokinetic strength of the hamstring muscles at 30°/s (eccentric contraction) (Nm).
Periodo de tiempo: Year 2
|
Maximum voluntary isokinetic strength of the hamstring muscles at 30°/s will be measured with the HUMA® /NORM™ device.
|
Year 2
|
Maximum voluntary isokinetic strength of the hamstring muscles at 30°/s (eccentric contraction) (Nm).
Periodo de tiempo: Year 5
|
Maximum voluntary isokinetic strength of the hamstring muscles at 30°/s will be measured with the HUMA® /NORM™ device.
|
Year 5
|
Endurance coefficient of the quadriceps muscles at 180°/s.
Periodo de tiempo: Day 0
|
Endurance coefficient will be estimated as a Σ Peak torque ratio of the last 3 contractions on the first 3 at 180°/s with the HUMA® /NORM™ device.
|
Day 0
|
Endurance coefficient of the quadriceps muscles at 180°/s.
Periodo de tiempo: Month 6
|
Endurance coefficient will be estimated as a Σ Peak torque ratio of the last 3 contractions on the first 3 at 180°/s with the HUMA® /NORM™ device.
|
Month 6
|
Endurance coefficient of the quadriceps muscles at 180°/s.
Periodo de tiempo: Year 1
|
Endurance coefficient will be estimated as a Σ Peak torque ratio of the last 3 contractions on the first 3 at 180°/s with the HUMA® /NORM™ device.
|
Year 1
|
Endurance coefficient of the quadriceps muscles at 180°/s.
Periodo de tiempo: Year 2
|
Endurance coefficient will be estimated as a Σ Peak torque ratio of the last 3 contractions on the first 3 at 180°/s with the HUMA® /NORM™ device.
|
Year 2
|
Endurance coefficient of the quadriceps muscles at 180°/s.
Periodo de tiempo: Year 5
|
Endurance coefficient will be estimated as a Σ Peak torque ratio of the last 3 contractions on the first 3 at 180°/s with the HUMA® /NORM™ device.
|
Year 5
|
Endurance coefficient of the hamstring muscles at 180°/s.
Periodo de tiempo: Day 0
|
Endurance coefficient will be estimated as a Σ Peak torque ratio of the last 3 contractions on the first 3 at 180°/s with the HUMA® /NORM™ device..
|
Day 0
|
Endurance coefficient of the hamstring muscles at 180°/s.
Periodo de tiempo: Month 6
|
Endurance coefficient will be estimated as a Σ Peak torque ratio of the last 3 contractions on the first 3 at 180°/s with the HUMA® /NORM™ device..
|
Month 6
|
Endurance coefficient of the hamstring muscles at 180°/s.
Periodo de tiempo: Year 1
|
Endurance coefficient will be estimated as a Σ Peak torque ratio of the last 3 contractions on the first 3 at 180°/s with the HUMA® /NORM™ device..
|
Year 1
|
Endurance coefficient of the hamstring muscles at 180°/s.
Periodo de tiempo: Year 2
|
Endurance coefficient will be estimated as a Σ Peak torque ratio of the last 3 contractions on the first 3 at 180°/s with the HUMA® /NORM™ device..
|
Year 2
|
Endurance coefficient of the hamstring muscles at 180°/s.
Periodo de tiempo: Year 5
|
Endurance coefficient will be estimated as a Σ Peak torque ratio of the last 3 contractions on the first 3 at 180°/s with the HUMA® /NORM™ device..
|
Year 5
|
Functional ratio
Periodo de tiempo: Day 0
|
Functional ratio will be estimated by dividing the maximum voluntary isokinetic strength of the hamstring muscles at 60°/s with the maximum voluntary isokinetic strength of the quadriceps muscles at 60°/s.
|
Day 0
|
Functional ratio
Periodo de tiempo: Month 6
|
Functional ratio will be estimated by dividing the maximum voluntary isokinetic strength of the hamstring muscles at 60°/s with the maximum voluntary isokinetic strength of the quadriceps muscles at 60°/s.
|
Month 6
|
Functional ratio
Periodo de tiempo: Year 1
|
Functional ratio will be estimated by dividing the maximum voluntary isokinetic strength of the hamstring muscles at 60°/s with the maximum voluntary isokinetic strength of the quadriceps muscles at 60°/s.
|
Year 1
|
Functional ratio
Periodo de tiempo: Year 2
|
Functional ratio will be estimated by dividing the maximum voluntary isokinetic strength of the hamstring muscles at 60°/s with the maximum voluntary isokinetic strength of the quadriceps muscles at 60°/s.
|
Year 2
|
Functional ratio
Periodo de tiempo: Year 5
|
Functional ratio will be estimated by dividing the maximum voluntary isokinetic strength of the hamstring muscles at 60°/s with the maximum voluntary isokinetic strength of the quadriceps muscles at 60°/s.
|
Year 5
|
Mixed ratio
Periodo de tiempo: Day 0
|
- Mixed ratio will be estimated by dividing the maximum voluntary isokinetic strength of the hamstring muscles at 30°/s (eccentric contraction) with the maximum voluntary isokinetic strength of the quadriceps muscles at 240°/s Title: Maximum voluntary strength of the quadriceps muscles at 60°/s.
|
Day 0
|
Mixed ratio
Periodo de tiempo: Month 6
|
- Mixed ratio will be estimated by dividing the maximum voluntary isokinetic strength of the hamstring muscles at 30°/s (eccentric contraction) with the maximum voluntary isokinetic strength of the quadriceps muscles at 240°/s Title: Maximum voluntary strength of the quadriceps muscles at 60°/s.
|
Month 6
|
Mixed ratio
Periodo de tiempo: Year 1
|
- Mixed ratio will be estimated by dividing the maximum voluntary isokinetic strength of the hamstring muscles at 30°/s (eccentric contraction) with the maximum voluntary isokinetic strength of the quadriceps muscles at 240°/s Title: Maximum voluntary strength of the quadriceps muscles at 60°/s.
|
Year 1
|
Mixed ratio
Periodo de tiempo: Year 2
|
- Mixed ratio will be estimated by dividing the maximum voluntary isokinetic strength of the hamstring muscles at 30°/s (eccentric contraction) with the maximum voluntary isokinetic strength of the quadriceps muscles at 240°/s Title: Maximum voluntary strength of the quadriceps muscles at 60°/s.
|
Year 2
|
Mixed ratio
Periodo de tiempo: Year 5
|
- Mixed ratio will be estimated by dividing the maximum voluntary isokinetic strength of the hamstring muscles at 30°/s (eccentric contraction) with the maximum voluntary isokinetic strength of the quadriceps muscles at 240°/s Title: Maximum voluntary strength of the quadriceps muscles at 60°/s.
|
Year 5
|
Maximum voluntary hand grip strength (Kg).
Periodo de tiempo: Day 0
|
Maximum voluntary hand grip strength will be measured with the Jamar® hydraulic dynamometer and with the Baseline® pneumatic dynamometer.
|
Day 0
|
Maximum voluntary hand grip strength (Kg).
Periodo de tiempo: Month 6
|
Maximum voluntary hand grip strength will be measured with the Jamar® hydraulic dynamometer and with the Baseline® pneumatic dynamometer.
|
Month 6
|
Maximum voluntary hand grip strength (Kg).
Periodo de tiempo: Year 1
|
Maximum voluntary hand grip strength will be measured with the Jamar® hydraulic dynamometer and with the Baseline® pneumatic dynamometer.
|
Year 1
|
Maximum voluntary hand grip strength (Kg).
Periodo de tiempo: Year 2
|
Maximum voluntary hand grip strength will be measured with the Jamar® hydraulic dynamometer and with the Baseline® pneumatic dynamometer.
|
Year 2
|
Maximum voluntary hand grip strength (Kg).
Periodo de tiempo: Year 5
|
Maximum voluntary hand grip strength will be measured with the Jamar® hydraulic dynamometer and with the Baseline® pneumatic dynamometer.
|
Year 5
|
Maximum voluntary pinch strength (Kg).
Periodo de tiempo: Day 0
|
Maximum voluntary pinch strength will be measured with the Baseline® pinch gauche test mechanical dynamometer.
|
Day 0
|
Maximum voluntary pinch strength (Kg).
Periodo de tiempo: Month 6
|
Maximum voluntary pinch strength will be measured with the Baseline® pinch gauche test mechanical dynamometer.
|
Month 6
|
Maximum voluntary pinch strength (Kg).
Periodo de tiempo: Year 1
|
Maximum voluntary pinch strength will be measured with the Baseline® pinch gauche test mechanical dynamometer.
|
Year 1
|
Maximum voluntary pinch strength (Kg).
Periodo de tiempo: Year 2
|
Maximum voluntary pinch strength will be measured with the Baseline® pinch gauche test mechanical dynamometer.
|
Year 2
|
Maximum voluntary pinch strength (Kg).
Periodo de tiempo: Year 5
|
Maximum voluntary pinch strength will be measured with the Baseline® pinch gauche test mechanical dynamometer.
|
Year 5
|
Hip passive joint range
Periodo de tiempo: Day 0
|
Hip joint range will be measured with a medical goniometer.
|
Day 0
|
Hip passive joint range
Periodo de tiempo: Month 6
|
Hip joint range will be measured with a medical goniometer.
|
Month 6
|
Hip passive joint range
Periodo de tiempo: Year 1
|
Hip joint range will be measured with a medical goniometer.
|
Year 1
|
Hip passive joint range
Periodo de tiempo: Year 2
|
Hip joint range will be measured with a medical goniometer.
|
Year 2
|
Hip passive joint range
Periodo de tiempo: Year 5
|
Hip joint range will be measured with a medical goniometer.
|
Year 5
|
Knee passive joint range.
Periodo de tiempo: Day 0
|
Knee joint range will be measured with a medical goniometer.
|
Day 0
|
Knee passive joint range.
Periodo de tiempo: Month 6
|
Knee joint range will be measured with a medical goniometer.
|
Month 6
|
Knee passive joint range.
Periodo de tiempo: Year 1
|
Knee joint range will be measured with a medical goniometer.
|
Year 1
|
Knee passive joint range.
Periodo de tiempo: Year 2
|
Knee joint range will be measured with a medical goniometer.
|
Year 2
|
Knee passive joint range.
Periodo de tiempo: Year 5
|
Knee joint range will be measured with a medical goniometer.
|
Year 5
|
Ankle passive joint range
Periodo de tiempo: Day 0
|
Ankle joint range will be measured with a medical goniometer.
|
Day 0
|
Ankle passive joint range
Periodo de tiempo: Month 6
|
Ankle joint range will be measured with a medical goniometer.
|
Month 6
|
Ankle passive joint range
Periodo de tiempo: Year 1
|
Ankle joint range will be measured with a medical goniometer.
|
Year 1
|
Ankle passive joint range
Periodo de tiempo: Year 2
|
Ankle joint range will be measured with a medical goniometer.
|
Year 2
|
Ankle passive joint range
Periodo de tiempo: Year 5
|
Ankle joint range will be measured with a medical goniometer.
|
Year 5
|
Lower and upper limb muscle power assessment (MRC)
Periodo de tiempo: Day 0
|
Lower and upper limb muscle power assessment will be performed by an experienced physician.
|
Day 0
|
Lower and upper limb muscle power assessment (MRC)
Periodo de tiempo: Month 6
|
Lower and upper limb muscle power assessment will be performed by an experienced physician.
|
Month 6
|
Lower and upper limb muscle power assessment (MRC)
Periodo de tiempo: Year 1
|
Lower and upper limb muscle power assessment will be performed by an experienced physician.
|
Year 1
|
Lower and upper limb muscle power assessment (MRC)
Periodo de tiempo: Year 2
|
Lower and upper limb muscle power assessment will be performed by an experienced physician.
|
Year 2
|
Lower and upper limb muscle power assessment (MRC)
Periodo de tiempo: Year 5
|
Lower and upper limb muscle power assessment will be performed by an experienced physician.
|
Year 5
|
Statokinesigram surface area (mm²)
Periodo de tiempo: Day 0
|
Statokinesigram surface area will be measured with the STATIPRO® static posturography platform.
|
Day 0
|
Statokinesigram surface area (mm²)
Periodo de tiempo: Month 6
|
Statokinesigram surface area will be measured with the STATIPRO® static posturography platform.
|
Month 6
|
Statokinesigram surface area (mm²)
Periodo de tiempo: Year 1
|
Statokinesigram surface area will be measured with the STATIPRO® static posturography platform.
|
Year 1
|
Statokinesigram surface area (mm²)
Periodo de tiempo: Year 2
|
Statokinesigram surface area will be measured with the STATIPRO® static posturography platform.
|
Year 2
|
Statokinesigram surface area (mm²)
Periodo de tiempo: Year 5
|
Statokinesigram surface area will be measured with the STATIPRO® static posturography platform.
|
Year 5
|
Stabilogram length (mm).
Periodo de tiempo: Day 0
|
Stabilogram length will be measured with the STATIPRO® static posturography platform
|
Day 0
|
Stabilogram length (mm).
Periodo de tiempo: Month 6
|
Stabilogram length will be measured with the STATIPRO® static posturography platform
|
Month 6
|
Stabilogram length (mm).
Periodo de tiempo: Year 1
|
Stabilogram length will be measured with the STATIPRO® static posturography platform
|
Year 1
|
Stabilogram length (mm).
Periodo de tiempo: Year 2
|
Stabilogram length will be measured with the STATIPRO® static posturography platform
|
Year 2
|
Stabilogram length (mm).
Periodo de tiempo: Year 5
|
Stabilogram length will be measured with the STATIPRO® static posturography platform
|
Year 5
|
Maximal deflection (forward, backward left and right).
Periodo de tiempo: Month 6
|
Maximal deflection will be measured with the STATIPRO® static posturography platform.
|
Month 6
|
Maximal deflection (forward, backward left and right).
Periodo de tiempo: Year 1
|
Maximal deflection will be measured with the STATIPRO® static posturography platform.
|
Year 1
|
Maximal deflection (forward, backward left and right).
Periodo de tiempo: Year 2
|
Maximal deflection will be measured with the STATIPRO® static posturography platform.
|
Year 2
|
Maximal deflection (forward, backward left and right).
Periodo de tiempo: Year 5
|
Maximal deflection will be measured with the STATIPRO® static posturography platform.
|
Year 5
|
Velocity variations (mm/s).
Periodo de tiempo: Day 0
|
: Velocity variations will be measured with the STATIPRO® static posturography platform.
|
Day 0
|
Velocity variations (mm/s).
Periodo de tiempo: Month 6
|
: Velocity variations will be measured with the STATIPRO® static posturography platform.
|
Month 6
|
Velocity variations (mm/s).
Periodo de tiempo: Year 1
|
: Velocity variations will be measured with the STATIPRO® static posturography platform.
|
Year 1
|
Velocity variations (mm/s).
Periodo de tiempo: Year 2
|
: Velocity variations will be measured with the STATIPRO® static posturography platform.
|
Year 2
|
Velocity variations (mm/s).
Periodo de tiempo: Year 5
|
: Velocity variations will be measured with the STATIPRO® static posturography platform.
|
Year 5
|
: Romberg ratio according to sway area
Periodo de tiempo: Day 0
|
Romberg ratio will be measured with the STATIPRO® static posturography platform.
|
Day 0
|
: Romberg ratio according to sway area
Periodo de tiempo: Month 6
|
Romberg ratio will be measured with the STATIPRO® static posturography platform.
|
Month 6
|
: Romberg ratio according to sway area
Periodo de tiempo: Year 1
|
Romberg ratio will be measured with the STATIPRO® static posturography platform.
|
Year 1
|
: Romberg ratio according to sway area
Periodo de tiempo: Year 2
|
Romberg ratio will be measured with the STATIPRO® static posturography platform.
|
Year 2
|
: Romberg ratio according to sway area
Periodo de tiempo: Year 5
|
Romberg ratio will be measured with the STATIPRO® static posturography platform.
|
Year 5
|
Romberg ratio according to center of pressure path length
Periodo de tiempo: Day 0
|
Romberg ratio will be measured with the STATIPRO® static posturography platform.
|
Day 0
|
Romberg ratio according to center of pressure path length
Periodo de tiempo: Month 6
|
Romberg ratio will be measured with the STATIPRO® static posturography platform.
|
Month 6
|
Romberg ratio according to center of pressure path length
Periodo de tiempo: Year 1
|
Romberg ratio will be measured with the STATIPRO® static posturography platform.
|
Year 1
|
Romberg ratio according to center of pressure path length
Periodo de tiempo: Year 2
|
Romberg ratio will be measured with the STATIPRO® static posturography platform.
|
Year 2
|
Romberg ratio according to center of pressure path length
Periodo de tiempo: Year 5
|
Romberg ratio will be measured with the STATIPRO® static posturography platform.
|
Year 5
|
: Plantar pressure ratio sway area.
Periodo de tiempo: Day 0
|
Plantar pressure ratio sway area will be measured with the STATIPRO® static posturography platform.
|
Day 0
|
: Plantar pressure ratio sway area.
Periodo de tiempo: Month 6
|
Plantar pressure ratio sway area will be measured with the STATIPRO® static posturography platform.
|
Month 6
|
: Plantar pressure ratio sway area.
Periodo de tiempo: Year 1
|
Plantar pressure ratio sway area will be measured with the STATIPRO® static posturography platform.
|
Year 1
|
: Plantar pressure ratio sway area.
Periodo de tiempo: Year 2
|
Plantar pressure ratio sway area will be measured with the STATIPRO® static posturography platform.
|
Year 2
|
: Plantar pressure ratio sway area.
Periodo de tiempo: Year 5
|
Plantar pressure ratio sway area will be measured with the STATIPRO® static posturography platform.
|
Year 5
|
Plantar pressure ratio length.
Periodo de tiempo: Day 0
|
Plantar pressure ratio length will be measured with the STATIPRO® static posturography platform.
|
Day 0
|
Plantar pressure ratio length.
Periodo de tiempo: Month 6
|
Plantar pressure ratio length will be measured with the STATIPRO® static posturography platform.
|
Month 6
|
Plantar pressure ratio length.
Periodo de tiempo: Year 1
|
Plantar pressure ratio length will be measured with the STATIPRO® static posturography platform.
|
Year 1
|
Plantar pressure ratio length.
Periodo de tiempo: Year 2
|
Plantar pressure ratio length will be measured with the STATIPRO® static posturography platform.
|
Year 2
|
Plantar pressure ratio length.
Periodo de tiempo: Year 5
|
Plantar pressure ratio length will be measured with the STATIPRO® static posturography platform.
|
Year 5
|
Walking velocity (cm/s).
Periodo de tiempo: Day 0
|
Walking velocity will be measured with the GAITRite® Electronic Walkway.
|
Day 0
|
Walking velocity (cm/s).
Periodo de tiempo: Month 6
|
Walking velocity will be measured with the GAITRite® Electronic Walkway.
|
Month 6
|
Walking velocity (cm/s).
Periodo de tiempo: Year 1
|
Walking velocity will be measured with the GAITRite® Electronic Walkway.
|
Year 1
|
Walking velocity (cm/s).
Periodo de tiempo: Year 2
|
Walking velocity will be measured with the GAITRite® Electronic Walkway.
|
Year 2
|
Walking velocity (cm/s).
Periodo de tiempo: Year 5
|
Walking velocity will be measured with the GAITRite® Electronic Walkway.
|
Year 5
|
Cadence (steps/min).
Periodo de tiempo: Day 0
|
: Cadence will be measured with the GAITRite® Electronic Walkway.
|
Day 0
|
Cadence (steps/min).
Periodo de tiempo: Month 6
|
: Cadence will be measured with the GAITRite® Electronic Walkway.
|
Month 6
|
Cadence (steps/min).
Periodo de tiempo: Year 1
|
: Cadence will be measured with the GAITRite® Electronic Walkway.
|
Year 1
|
Cadence (steps/min).
Periodo de tiempo: Year 2
|
: Cadence will be measured with the GAITRite® Electronic Walkway.
|
Year 2
|
Cadence (steps/min).
Periodo de tiempo: Year 5
|
: Cadence will be measured with the GAITRite® Electronic Walkway.
|
Year 5
|
Step length (left and right foot) (cm)
Periodo de tiempo: DAy 0
|
Step length will be measured with the GAITRite® Electronic Walkway.
|
DAy 0
|
Step length (left and right foot) (cm)
Periodo de tiempo: Month 6
|
Step length will be measured with the GAITRite® Electronic Walkway.
|
Month 6
|
Step length (left and right foot) (cm)
Periodo de tiempo: Year 1
|
Step length will be measured with the GAITRite® Electronic Walkway.
|
Year 1
|
Step length (left and right foot) (cm)
Periodo de tiempo: Year 2
|
Step length will be measured with the GAITRite® Electronic Walkway.
|
Year 2
|
Step length (left and right foot) (cm)
Periodo de tiempo: Year 5
|
Step length will be measured with the GAITRite® Electronic Walkway.
|
Year 5
|
Stride length (cm).
Periodo de tiempo: Day 0
|
Stride length will be measured with the GAITRite® Electronic Walkway.
|
Day 0
|
Stride length (cm).
Periodo de tiempo: month 6
|
Stride length will be measured with the GAITRite® Electronic Walkway.
|
month 6
|
Stride length (cm).
Periodo de tiempo: year 1
|
Stride length will be measured with the GAITRite® Electronic Walkway.
|
year 1
|
Stride length (cm).
Periodo de tiempo: year 2
|
Stride length will be measured with the GAITRite® Electronic Walkway.
|
year 2
|
Stride length (cm).
Periodo de tiempo: year 5
|
Stride length will be measured with the GAITRite® Electronic Walkway.
|
year 5
|
Single support time left and right foot (s).
Periodo de tiempo: Day 0
|
Single support time will be measured with the GAITRite® Electronic Walkway.
|
Day 0
|
Single support time left and right foot (s).
Periodo de tiempo: Month 6
|
Single support time will be measured with the GAITRite® Electronic Walkway.
|
Month 6
|
Single support time left and right foot (s).
Periodo de tiempo: Year 1
|
Single support time will be measured with the GAITRite® Electronic Walkway.
|
Year 1
|
Single support time left and right foot (s).
Periodo de tiempo: Year 2
|
Single support time will be measured with the GAITRite® Electronic Walkway.
|
Year 2
|
Single support time left and right foot (s).
Periodo de tiempo: Year 5
|
Single support time will be measured with the GAITRite® Electronic Walkway.
|
Year 5
|
Double support time (s).
Periodo de tiempo: Day 0
|
: Double support time will be measured with the GAITRite® Electronic Walkway.
|
Day 0
|
Double support time (s).
Periodo de tiempo: Month 6
|
: Double support time will be measured with the GAITRite® Electronic Walkway.
|
Month 6
|
Double support time (s).
Periodo de tiempo: YEar 1
|
: Double support time will be measured with the GAITRite® Electronic Walkway.
|
YEar 1
|
Double support time (s).
Periodo de tiempo: Year 2
|
: Double support time will be measured with the GAITRite® Electronic Walkway.
|
Year 2
|
Double support time (s).
Periodo de tiempo: Year 5
|
: Double support time will be measured with the GAITRite® Electronic Walkway.
|
Year 5
|
Swing time (s).
Periodo de tiempo: Day 0
|
: Swing time will be measured with the GAITRite® Electronic Walkway.
|
Day 0
|
Swing time (s).
Periodo de tiempo: Month 6
|
: Swing time will be measured with the GAITRite® Electronic Walkway.
|
Month 6
|
Swing time (s).
Periodo de tiempo: Year 1
|
: Swing time will be measured with the GAITRite® Electronic Walkway.
|
Year 1
|
Swing time (s).
Periodo de tiempo: Year 2
|
: Swing time will be measured with the GAITRite® Electronic Walkway.
|
Year 2
|
Swing time (s).
Periodo de tiempo: Year 5
|
: Swing time will be measured with the GAITRite® Electronic Walkway.
|
Year 5
|
Swing phase (as a % of walking cycle).
Periodo de tiempo: DAy 0
|
: Swing phase will be measured with the GAITRite® Electronic Walkway.
|
DAy 0
|
Swing phase (as a % of walking cycle).
Periodo de tiempo: Month 6
|
: Swing phase will be measured with the GAITRite® Electronic Walkway.
|
Month 6
|
Swing phase (as a % of walking cycle).
Periodo de tiempo: Year 1
|
: Swing phase will be measured with the GAITRite® Electronic Walkway.
|
Year 1
|
Swing phase (as a % of walking cycle).
Periodo de tiempo: Year 2
|
: Swing phase will be measured with the GAITRite® Electronic Walkway.
|
Year 2
|
Swing phase (as a % of walking cycle).
Periodo de tiempo: Year 5
|
: Swing phase will be measured with the GAITRite® Electronic Walkway.
|
Year 5
|
Stance phase (as a % of walking cycle).
Periodo de tiempo: Day 0
|
Stance phase will be measured with the GAITRite® Electronic Walkway.
|
Day 0
|
Stance phase (as a % of walking cycle).
Periodo de tiempo: Month 6
|
Stance phase will be measured with the GAITRite® Electronic Walkway.
|
Month 6
|
Stance phase (as a % of walking cycle).
Periodo de tiempo: Year 1
|
Stance phase will be measured with the GAITRite® Electronic Walkway.
|
Year 1
|
Stance phase (as a % of walking cycle).
Periodo de tiempo: Year 2
|
Stance phase will be measured with the GAITRite® Electronic Walkway.
|
Year 2
|
Stance phase (as a % of walking cycle).
Periodo de tiempo: Year 5
|
Stance phase will be measured with the GAITRite® Electronic Walkway.
|
Year 5
|
Vo2max (maximal oxygen consumption) (mL/Kg/min).
Periodo de tiempo: Day 0
|
: Vo2max will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.
|
Day 0
|
Vo2max (maximal oxygen consumption) (mL/Kg/min).
Periodo de tiempo: Month 6
|
: Vo2max will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.
|
Month 6
|
Vo2max (maximal oxygen consumption) (mL/Kg/min).
Periodo de tiempo: Year 1
|
: Vo2max will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.
|
Year 1
|
Vo2max (maximal oxygen consumption) (mL/Kg/min).
Periodo de tiempo: Year 2
|
: Vo2max will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.
|
Year 2
|
Vo2max (maximal oxygen consumption) (mL/Kg/min).
Periodo de tiempo: Year 5
|
: Vo2max will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.
|
Year 5
|
Maximum heart rate (bpm).
Periodo de tiempo: Day 0
|
Maximum heart rate will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.
|
Day 0
|
Maximum heart rate (bpm).
Periodo de tiempo: Month 6
|
Maximum heart rate will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.
|
Month 6
|
Maximum heart rate (bpm).
Periodo de tiempo: Year 1
|
Maximum heart rate will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.
|
Year 1
|
Maximum heart rate (bpm).
Periodo de tiempo: Year 2
|
Maximum heart rate will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.
|
Year 2
|
Maximum heart rate (bpm).
Periodo de tiempo: Year 5
|
Maximum heart rate will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.
|
Year 5
|
Maximum power (Watts).
Periodo de tiempo: Day 0
|
Maximum power will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.
|
Day 0
|
Maximum power (Watts).
Periodo de tiempo: Month 6
|
Maximum power will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.
|
Month 6
|
Maximum power (Watts).
Periodo de tiempo: Year 1
|
Maximum power will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.
|
Year 1
|
Maximum power (Watts).
Periodo de tiempo: Year 2
|
Maximum power will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.
|
Year 2
|
Maximum power (Watts).
Periodo de tiempo: Year 5
|
Maximum power will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.
|
Year 5
|
Threshold power (Watts).
Periodo de tiempo: Day 0
|
Threshold power will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.
|
Day 0
|
Threshold power (Watts).
Periodo de tiempo: Month 6
|
Threshold power will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.
|
Month 6
|
Threshold power (Watts).
Periodo de tiempo: Year 1
|
Threshold power will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.
|
Year 1
|
Threshold power (Watts).
Periodo de tiempo: Year 2
|
Threshold power will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.
|
Year 2
|
Threshold power (Watts).
Periodo de tiempo: Year 5
|
Threshold power will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.
|
Year 5
|
Threshold heart rate (bpm).
Periodo de tiempo: DAy 0
|
Threshold heart will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.
|
DAy 0
|
Threshold heart rate (bpm).
Periodo de tiempo: Month 6
|
Threshold heart will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.
|
Month 6
|
Threshold heart rate (bpm).
Periodo de tiempo: Year 1
|
Threshold heart will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.
|
Year 1
|
Threshold heart rate (bpm).
Periodo de tiempo: Year 2
|
Threshold heart will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.
|
Year 2
|
Threshold heart rate (bpm).
Periodo de tiempo: Year 5
|
Threshold heart will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.
|
Year 5
|
Forced vital Capacity (L).
Periodo de tiempo: Day 0
|
: Forced vital Capacity will be measured with a spirometry test.
|
Day 0
|
Forced vital Capacity (L).
Periodo de tiempo: Month 6
|
: Forced vital Capacity will be measured with a spirometry test.
|
Month 6
|
Forced vital Capacity (L).
Periodo de tiempo: Year 1
|
: Forced vital Capacity will be measured with a spirometry test.
|
Year 1
|
Forced vital Capacity (L).
Periodo de tiempo: Year 2
|
: Forced vital Capacity will be measured with a spirometry test.
|
Year 2
|
Forced vital Capacity (L).
Periodo de tiempo: Year 5
|
: Forced vital Capacity will be measured with a spirometry test.
|
Year 5
|
Forced Expiratory volume (L)
Periodo de tiempo: Day 0
|
Forced Expiratory volume will be measured with a spirometry test.
|
Day 0
|
Forced Expiratory volume (L)
Periodo de tiempo: Month 6
|
Forced Expiratory volume will be measured with a spirometry test.
|
Month 6
|
Forced Expiratory volume (L)
Periodo de tiempo: Year 1
|
Forced Expiratory volume will be measured with a spirometry test.
|
Year 1
|
Forced Expiratory volume (L)
Periodo de tiempo: Year 2
|
Forced Expiratory volume will be measured with a spirometry test.
|
Year 2
|
Forced Expiratory volume (L)
Periodo de tiempo: Year 5
|
Forced Expiratory volume will be measured with a spirometry test.
|
Year 5
|
Tiffeneau ratio (%).
Periodo de tiempo: Day 0
|
Tiffeneau ratio will be calculated by dividing the Forced Expiratory volume to the Forced vital Capacity.
|
Day 0
|
Tiffeneau ratio (%).
Periodo de tiempo: Month 6
|
Tiffeneau ratio will be calculated by dividing the Forced Expiratory volume to the Forced vital Capacity.
|
Month 6
|
Tiffeneau ratio (%).
Periodo de tiempo: Year 1
|
Tiffeneau ratio will be calculated by dividing the Forced Expiratory volume to the Forced vital Capacity.
|
Year 1
|
Tiffeneau ratio (%).
Periodo de tiempo: Year 2
|
Tiffeneau ratio will be calculated by dividing the Forced Expiratory volume to the Forced vital Capacity.
|
Year 2
|
Tiffeneau ratio (%).
Periodo de tiempo: Year 5
|
Tiffeneau ratio will be calculated by dividing the Forced Expiratory volume to the Forced vital Capacity.
|
Year 5
|
Ventilatory reserve (%).
Periodo de tiempo: Day 0
|
Ventilatory reserve will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.
|
Day 0
|
Ventilatory reserve (%).
Periodo de tiempo: Month 6
|
Ventilatory reserve will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.
|
Month 6
|
Ventilatory reserve (%).
Periodo de tiempo: Year 1
|
Ventilatory reserve will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.
|
Year 1
|
Ventilatory reserve (%).
Periodo de tiempo: Year 2
|
Ventilatory reserve will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.
|
Year 2
|
Ventilatory reserve (%).
Periodo de tiempo: Year 5
|
Ventilatory reserve will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.
|
Year 5
|
Physical activity
Periodo de tiempo: Day 0
|
Physical activity will be measured using the Global Physical Activity Questionnaire (GPAQ)
|
Day 0
|
Physical activity
Periodo de tiempo: Month 6
|
Physical activity will be measured using the Global Physical Activity Questionnaire (GPAQ)
|
Month 6
|
Physical activity
Periodo de tiempo: Year 1
|
Physical activity will be measured using the Global Physical Activity Questionnaire (GPAQ)
|
Year 1
|
Physical activity
Periodo de tiempo: Year 2
|
Physical activity will be measured using the Global Physical Activity Questionnaire (GPAQ)
|
Year 2
|
Physical activity
Periodo de tiempo: Year 5
|
Physical activity will be measured using the Global Physical Activity Questionnaire (GPAQ)
|
Year 5
|
Functional capacity timed-up and go
Periodo de tiempo: Day 0
|
Functional capacity will be evaluated using the Timed-Up and Go test.
|
Day 0
|
Functional capacity timed-up and go
Periodo de tiempo: Month 6
|
Functional capacity will be evaluated using the Timed-Up and Go test.
|
Month 6
|
Functional capacity timed-up and go
Periodo de tiempo: Year 1
|
Functional capacity will be evaluated using the Timed-Up and Go test.
|
Year 1
|
Functional capacity timed-up and go
Periodo de tiempo: Year 2
|
Functional capacity will be evaluated using the Timed-Up and Go test.
|
Year 2
|
Functional capacity timed-up and go
Periodo de tiempo: Year 5
|
Functional capacity will be evaluated using the Timed-Up and Go test.
|
Year 5
|
Functional capacity TDM6
Periodo de tiempo: Day 0
|
Functional capacity will be evaluated using the 6-minute walk test.
|
Day 0
|
Functional capacity TDM6
Periodo de tiempo: Month 6
|
Functional capacity will be evaluated using the 6-minute walk test.
|
Month 6
|
Functional capacity TDM6
Periodo de tiempo: Year 1
|
Functional capacity will be evaluated using the 6-minute walk test.
|
Year 1
|
Functional capacity TDM6
Periodo de tiempo: Year 2
|
Functional capacity will be evaluated using the 6-minute walk test.
|
Year 2
|
Functional capacity TDM6
Periodo de tiempo: Year 5
|
Functional capacity will be evaluated using the 6-minute walk test.
|
Year 5
|
Functional capacity Five Times Sit to Stand test.
Periodo de tiempo: Day 0
|
Functional capacity will be evaluated using the Five Times Sit to Stand test.
|
Day 0
|
Functional capacity Five Times Sit to Stand test.
Periodo de tiempo: Month 6
|
Functional capacity will be evaluated using the Five Times Sit to Stand test.
|
Month 6
|
Functional capacity Five Times Sit to Stand test.
Periodo de tiempo: Year 1
|
Functional capacity will be evaluated using the Five Times Sit to Stand test.
|
Year 1
|
Functional capacity Five Times Sit to Stand test.
Periodo de tiempo: Year 2
|
Functional capacity will be evaluated using the Five Times Sit to Stand test.
|
Year 2
|
Functional capacity Five Times Sit to Stand test.
Periodo de tiempo: Year 5
|
Functional capacity will be evaluated using the Five Times Sit to Stand test.
|
Year 5
|
Functional capacity SPPB
Periodo de tiempo: Day 0
|
Functional capacity will be evaluated using the Five Times Sit to Stand test.Functional capacity will be evaluated using the Short Physical Performance Battery test.
|
Day 0
|
Functional capacity SPPB
Periodo de tiempo: Month 6
|
Functional capacity will be evaluated using the Five Times Sit to Stand test.Functional capacity will be evaluated using the Short Physical Performance Battery test.
|
Month 6
|
Functional capacity SPPB
Periodo de tiempo: Year 1
|
Functional capacity will be evaluated using the Five Times Sit to Stand test.Functional capacity will be evaluated using the Short Physical Performance Battery test.
|
Year 1
|
Functional capacity SPPB
Periodo de tiempo: Year 2
|
Functional capacity will be evaluated using the Five Times Sit to Stand test.Functional capacity will be evaluated using the Short Physical Performance Battery test.
|
Year 2
|
Functional capacity SPPB
Periodo de tiempo: Year 5
|
Functional capacity will be evaluated using the Five Times Sit to Stand test.Functional capacity will be evaluated using the Short Physical Performance Battery test.
|
Year 5
|
Functional capacity the mini-BESTest.
Periodo de tiempo: Day 0
|
Functional capacity will be evaluated using the mini-BESTest.
|
Day 0
|
Functional capacity the mini-BESTest.
Periodo de tiempo: Month 6
|
Functional capacity will be evaluated using the mini-BESTest.
|
Month 6
|
Functional capacity the mini-BESTest.
Periodo de tiempo: Year 1
|
Functional capacity will be evaluated using the mini-BESTest.
|
Year 1
|
Functional capacity the mini-BESTest.
Periodo de tiempo: Year 2
|
Functional capacity will be evaluated using the mini-BESTest.
|
Year 2
|
Functional capacity the mini-BESTest.
Periodo de tiempo: Year 5
|
Functional capacity will be evaluated using the mini-BESTest.
|
Year 5
|
Functional capacity Berg Balance Scale.
Periodo de tiempo: Day 0
|
Functional capacity will be evaluated using the Berg Balance Scale.
|
Day 0
|
Functional capacity Berg Balance Scale.
Periodo de tiempo: Month 6
|
Functional capacity will be evaluated using the Berg Balance Scale.
|
Month 6
|
Functional capacity Berg Balance Scale.
Periodo de tiempo: Year 1
|
Functional capacity will be evaluated using the Berg Balance Scale.
|
Year 1
|
Functional capacity Berg Balance Scale.
Periodo de tiempo: Year 2
|
Functional capacity will be evaluated using the Berg Balance Scale.
|
Year 2
|
Functional capacity Berg Balance Scale.
Periodo de tiempo: Year 5
|
Functional capacity will be evaluated using the Berg Balance Scale.
|
Year 5
|
Functional capacity 10-meter walk test
Periodo de tiempo: Day 0
|
Functional capacity will be evaluated using the 10-meter walk test (at usual and maximal pace).
|
Day 0
|
Functional capacity 10-meter walk test
Periodo de tiempo: Month 6
|
Functional capacity will be evaluated using the 10-meter walk test (at usual and maximal pace).
|
Month 6
|
Functional capacity 10-meter walk test
Periodo de tiempo: Year 1
|
Functional capacity will be evaluated using the 10-meter walk test (at usual and maximal pace).
|
Year 1
|
Functional capacity 10-meter walk test
Periodo de tiempo: Year 2
|
Functional capacity will be evaluated using the 10-meter walk test (at usual and maximal pace).
|
Year 2
|
Functional capacity 10-meter walk test
Periodo de tiempo: Year 5
|
Functional capacity will be evaluated using the 10-meter walk test (at usual and maximal pace).
|
Year 5
|
Dyspnea
Periodo de tiempo: Day 0
|
Dyspnea will be evaluated by a Numeric Rating scale ranging from 0 to 10.
|
Day 0
|
Dyspnea
Periodo de tiempo: Month 6
|
Dyspnea will be evaluated by a Numeric Rating scale ranging from 0 to 10.
|
Month 6
|
Dyspnea
Periodo de tiempo: Year 1
|
Dyspnea will be evaluated by a Numeric Rating scale ranging from 0 to 10.
|
Year 1
|
Dyspnea
Periodo de tiempo: Year 2
|
Dyspnea will be evaluated by a Numeric Rating scale ranging from 0 to 10.
|
Year 2
|
Dyspnea
Periodo de tiempo: Year 5
|
Dyspnea will be evaluated by a Numeric Rating scale ranging from 0 to 10.
|
Year 5
|
Perceived exertion before, during and after effort
Periodo de tiempo: DAy 0
|
Perceived exertion will be evaluated by a Numeric Rating scale ranging from 0 to 10.
|
DAy 0
|
Perceived exertion before, during and after effort
Periodo de tiempo: Month 6
|
Perceived exertion will be evaluated by a Numeric Rating scale ranging from 0 to 10.
|
Month 6
|
Perceived exertion before, during and after effort
Periodo de tiempo: Year 1
|
Perceived exertion will be evaluated by a Numeric Rating scale ranging from 0 to 10.
|
Year 1
|
Perceived exertion before, during and after effort
Periodo de tiempo: Year 2
|
Perceived exertion will be evaluated by a Numeric Rating scale ranging from 0 to 10.
|
Year 2
|
Perceived exertion before, during and after effort
Periodo de tiempo: Year 5
|
Perceived exertion will be evaluated by a Numeric Rating scale ranging from 0 to 10.
|
Year 5
|
Pain
Periodo de tiempo: Day 0
|
: Pain will be measured by a visual analogue scale (VAS) ranging from 0 to 10 and possibly as appropriate by other questionnaires or specific scales.
|
Day 0
|
Pain
Periodo de tiempo: Month 6
|
: Pain will be measured by a visual analogue scale (VAS) ranging from 0 to 10 and possibly as appropriate by other questionnaires or specific scales.
|
Month 6
|
Pain
Periodo de tiempo: Year 1
|
: Pain will be measured by a visual analogue scale (VAS) ranging from 0 to 10 and possibly as appropriate by other questionnaires or specific scales.
|
Year 1
|
Pain
Periodo de tiempo: Year 2
|
: Pain will be measured by a visual analogue scale (VAS) ranging from 0 to 10 and possibly as appropriate by other questionnaires or specific scales.
|
Year 2
|
Pain
Periodo de tiempo: Year 5
|
: Pain will be measured by a visual analogue scale (VAS) ranging from 0 to 10 and possibly as appropriate by other questionnaires or specific scales.
|
Year 5
|
Sarcopenia risk
Periodo de tiempo: Day 0
|
Sarcopenia risk will be evaluated with the SARC-F Questionnaire.
|
Day 0
|
Sarcopenia risk
Periodo de tiempo: Month 6
|
Sarcopenia risk will be evaluated with the SARC-F Questionnaire.
|
Month 6
|
Sarcopenia risk
Periodo de tiempo: Year 1
|
Sarcopenia risk will be evaluated with the SARC-F Questionnaire.
|
Year 1
|
Sarcopenia risk
Periodo de tiempo: Year 2
|
Sarcopenia risk will be evaluated with the SARC-F Questionnaire.
|
Year 2
|
Sarcopenia risk
Periodo de tiempo: Year 5
|
Sarcopenia risk will be evaluated with the SARC-F Questionnaire.
|
Year 5
|
Social insecurity
Periodo de tiempo: Day 0
|
Social insecurity will be evaluated with the EPICES Score Questionnaire.
|
Day 0
|
Social insecurity
Periodo de tiempo: Month 6
|
Social insecurity will be evaluated with the EPICES Score Questionnaire.
|
Month 6
|
Social insecurity
Periodo de tiempo: Year 1
|
Social insecurity will be evaluated with the EPICES Score Questionnaire.
|
Year 1
|
Social insecurity
Periodo de tiempo: Year 2
|
Social insecurity will be evaluated with the EPICES Score Questionnaire.
|
Year 2
|
Social insecurity
Periodo de tiempo: Year 5
|
Social insecurity will be evaluated with the EPICES Score Questionnaire.
|
Year 5
|
Kinesiophobia
Periodo de tiempo: Day 0
|
Kinesiophobia will be evaluated with the TAMPA Scale.
|
Day 0
|
Kinesiophobia
Periodo de tiempo: Month 6
|
Kinesiophobia will be evaluated with the TAMPA Scale.
|
Month 6
|
Kinesiophobia
Periodo de tiempo: Year 1
|
Kinesiophobia will be evaluated with the TAMPA Scale.
|
Year 1
|
Kinesiophobia
Periodo de tiempo: Year 2
|
Kinesiophobia will be evaluated with the TAMPA Scale.
|
Year 2
|
Kinesiophobia
Periodo de tiempo: Year 5
|
Kinesiophobia will be evaluated with the TAMPA Scale.
|
Year 5
|
Quality of life
Periodo de tiempo: Day 0
|
Quality of life will be evaluated with the 36-Item Short Form Survey.
|
Day 0
|
Quality of life
Periodo de tiempo: Month 6
|
Quality of life will be evaluated with the 36-Item Short Form Survey.
|
Month 6
|
Quality of life
Periodo de tiempo: Year 1
|
Quality of life will be evaluated with the 36-Item Short Form Survey.
|
Year 1
|
Quality of life
Periodo de tiempo: Year 2
|
Quality of life will be evaluated with the 36-Item Short Form Survey.
|
Year 2
|
Quality of life
Periodo de tiempo: Year 5
|
Quality of life will be evaluated with the 36-Item Short Form Survey.
|
Year 5
|
: Balance confidence in performing various activities
Periodo de tiempo: Day 0
|
Self-report balance confidence will be evaluated with the Activities-specific Balance Confidence (ABC) Scale.vey.
|
Day 0
|
: Balance confidence in performing various activities
Periodo de tiempo: Month 6
|
Self-report balance confidence will be evaluated with the Activities-specific Balance Confidence (ABC) Scale.vey.
|
Month 6
|
: Balance confidence in performing various activities
Periodo de tiempo: Year 1
|
Self-report balance confidence will be evaluated with the Activities-specific Balance Confidence (ABC) Scale.vey.
|
Year 1
|
: Balance confidence in performing various activities
Periodo de tiempo: Year 2
|
Self-report balance confidence will be evaluated with the Activities-specific Balance Confidence (ABC) Scale.vey.
|
Year 2
|
: Balance confidence in performing various activities
Periodo de tiempo: Year 5
|
Self-report balance confidence will be evaluated with the Activities-specific Balance Confidence (ABC) Scale.vey.
|
Year 5
|
Functioning in regards to activities of daily living.
Periodo de tiempo: Day 0
|
Functioning will be evaluated with the Lawton Instrumental Activities of Daily Living (IADL) Scale.
|
Day 0
|
Functioning in regards to activities of daily living.
Periodo de tiempo: Month 6
|
Functioning will be evaluated with the Lawton Instrumental Activities of Daily Living (IADL) Scale.
|
Month 6
|
Functioning in regards to activities of daily living.
Periodo de tiempo: Year 1
|
Functioning will be evaluated with the Lawton Instrumental Activities of Daily Living (IADL) Scale.
|
Year 1
|
Functioning in regards to activities of daily living.
Periodo de tiempo: Year 2
|
Functioning will be evaluated with the Lawton Instrumental Activities of Daily Living (IADL) Scale.
|
Year 2
|
Functioning in regards to activities of daily living.
Periodo de tiempo: Year 5
|
Functioning will be evaluated with the Lawton Instrumental Activities of Daily Living (IADL) Scale.
|
Year 5
|
Exhaustion
Periodo de tiempo: Day 0
|
Exhaustion will be evaluated with the FACIT-F Questionnaire.
|
Day 0
|
Exhaustion
Periodo de tiempo: Month 6
|
Exhaustion will be evaluated with the FACIT-F Questionnaire.
|
Month 6
|
Exhaustion
Periodo de tiempo: Year 1
|
Exhaustion will be evaluated with the FACIT-F Questionnaire.
|
Year 1
|
Exhaustion
Periodo de tiempo: Year 2
|
Exhaustion will be evaluated with the FACIT-F Questionnaire.
|
Year 2
|
Exhaustion
Periodo de tiempo: Year 5
|
Exhaustion will be evaluated with the FACIT-F Questionnaire.
|
Year 5
|
Patient's opinion about their knee and associated problems
Periodo de tiempo: Day 0
|
: Outcomes will be evaluated with the Knee Injury and Osteoarthritis Outcome Score (KOOS).
|
Day 0
|
Patient's opinion about their knee and associated problems
Periodo de tiempo: Month 6
|
: Outcomes will be evaluated with the Knee Injury and Osteoarthritis Outcome Score (KOOS).
|
Month 6
|
Patient's opinion about their knee and associated problems
Periodo de tiempo: Year 1
|
: Outcomes will be evaluated with the Knee Injury and Osteoarthritis Outcome Score (KOOS).
|
Year 1
|
Patient's opinion about their knee and associated problems
Periodo de tiempo: Year 2
|
: Outcomes will be evaluated with the Knee Injury and Osteoarthritis Outcome Score (KOOS).
|
Year 2
|
Patient's opinion about their knee and associated problems
Periodo de tiempo: Year 5
|
: Outcomes will be evaluated with the Knee Injury and Osteoarthritis Outcome Score (KOOS).
|
Year 5
|
Patient's opinion about their hip and associated problems
Periodo de tiempo: Day 0
|
Outcomes will be evaluated with the Hip Injury and Osteoarthritis Outcome Score (HOOS).
|
Day 0
|
Patient's opinion about their hip and associated problems
Periodo de tiempo: Month 6
|
Outcomes will be evaluated with the Hip Injury and Osteoarthritis Outcome Score (HOOS).
|
Month 6
|
Patient's opinion about their hip and associated problems
Periodo de tiempo: Year 1
|
Outcomes will be evaluated with the Hip Injury and Osteoarthritis Outcome Score (HOOS).
|
Year 1
|
Patient's opinion about their hip and associated problems
Periodo de tiempo: Year 2
|
Outcomes will be evaluated with the Hip Injury and Osteoarthritis Outcome Score (HOOS).
|
Year 2
|
Patient's opinion about their hip and associated problems
Periodo de tiempo: Year 5
|
Outcomes will be evaluated with the Hip Injury and Osteoarthritis Outcome Score (HOOS).
|
Year 5
|
Predicting discharge destination after total joint arthroplasty.
Periodo de tiempo: Day 0
|
: Discharge destination will be evaluated with the Risk Assessment and Prediction Tool (RAPT);
|
Day 0
|
Predicting discharge destination after total joint arthroplasty.
Periodo de tiempo: Month 6
|
: Discharge destination will be evaluated with the Risk Assessment and Prediction Tool (RAPT);
|
Month 6
|
Physical function in myositis patients
Periodo de tiempo: Day 0
|
Physical function will be evaluated with the Stanford Health Assessment Questionnaire.
|
Day 0
|
Physical function in myositis patients
Periodo de tiempo: Month 6
|
Physical function will be evaluated with the Stanford Health Assessment Questionnaire.
|
Month 6
|
Physical function in myositis patients
Periodo de tiempo: Year 1
|
Physical function will be evaluated with the Stanford Health Assessment Questionnaire.
|
Year 1
|
Physical function in myositis patients
Periodo de tiempo: Year 2
|
Physical function will be evaluated with the Stanford Health Assessment Questionnaire.
|
Year 2
|
Physical function in myositis patients
Periodo de tiempo: Year 5
|
Physical function will be evaluated with the Stanford Health Assessment Questionnaire.
|
Year 5
|
Quality of life in Parkinson's Disease
Periodo de tiempo: Day 0
|
Quality of life will be measured with the Parkinson's Disease Questionnaire-39 (PDQ-39).
|
Day 0
|
Quality of life in Parkinson's Disease
Periodo de tiempo: Month 6
|
Quality of life will be measured with the Parkinson's Disease Questionnaire-39 (PDQ-39).
|
Month 6
|
Quality of life in Parkinson's Disease
Periodo de tiempo: Year 1
|
Quality of life will be measured with the Parkinson's Disease Questionnaire-39 (PDQ-39).
|
Year 1
|
Quality of life in Parkinson's Disease
Periodo de tiempo: Year 2
|
Quality of life will be measured with the Parkinson's Disease Questionnaire-39 (PDQ-39).
|
Year 2
|
Quality of life in Parkinson's Disease
Periodo de tiempo: Year 5
|
Quality of life will be measured with the Parkinson's Disease Questionnaire-39 (PDQ-39).
|
Year 5
|
Actimetry.
Periodo de tiempo: during 5 consecutive days after day 0
|
Actimetry data (energy expenditure, number of steps, sedentary time, total physical activity, etc.) will be obtained with the WGT3X-BT Actigraph inertial sensor unit.
|
during 5 consecutive days after day 0
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Frédéric Costes, University Hospital, Clermont-Ferrand
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Necrosis
- Enfermedades cardiovasculares
- Enfermedades Vasculares
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Enfermedades de las vías respiratorias
- Arteriosclerosis
- Enfermedades arteriales oclusivas
- Enfermedades pulmonares
- Atributos de la enfermedad
- Sobrenutrición
- Trastornos Nutricionales
- Exceso de peso
- Peso corporal
- Trastornos Parkinsonianos
- Enfermedades de los ganglios basales
- Trastornos del movimiento
- Sinucleinopatías
- Enfermedades neurodegenerativas
- Obesidad
- Enfermedades Pulmonares Obstructivas
- Enfermedad Pulmonar Obstructiva Crónica
- Enfermedad de Parkinson
- Enfermedad crónica
- Aterosclerosis
- Gangrena
Otros números de identificación del estudio
- RBHP 2019 COSTES
- 2019-A01017-50 (Otro identificador: 2019-A01017-50)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Enfermedad de Parkinson
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ProgenaBiomeReclutamientoEnfermedad de Parkinson | Enfermedad de Parkinson con demencia | Síndrome de Parkinson-Demencia | Enfermedad de Parkinson 2 | Enfermedad de Parkinson 3 | Enfermedad de Parkinson 4Estados Unidos
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