Evaluation of Impaired Mobility in Chronic Illness Constitution of a Cohort (EVALMOB)

Chronic illness is a public health issue and mobility loss is frequent in this population. Among its' multiple physical and psychological consequences, increased mortality and cardiovascular morbidity seem the main concern. Therefore, the exploration of locomotor deficiencies, physical capacities and metabolism of patients with chronic illnesses constitutes a major challenge both for the treatment of causal pathologies, as well as for evaluating the impact of therapeutic interventions, the benefit of which will be an improvement in physical capacities and ultimately mobility. In view of the hypothesis of an increase in the prevalence of mobility disorders in this population, this approach is part of a logic of screening and improving the effectiveness of the care of these patients with a multidisciplinary evaluation of individual risks. The EVALMOB protocol was designed in order to try to determine a standard profile of "dysmobility" in patients with chronic illness

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease; Joint Osteoarthritis; Atherosclerosis of the Distal Arteries, Without Gangrene; Chronic Obstructive Pulmonary Disease, Unspecified; Obesity, Unspecified
• Intervention / Treatment: Other: Development of a screening algorithm designed to determine a "dysmobility" profile in patients with chronic illness.

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 5000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • Recruiting
    • CHU Clermont Ferrand
    • Principal Investigator: Frédéric Costes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Other: Development of a screening algorithm designed to determine a "dysmobility" profile in patients with chronic illness.; 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.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
dismobility score calculated from the results reported in secondary outcomes	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	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	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	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	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum voluntary isometric strength of the quadriceps muscles at 45° (Nm).	: Maximum voluntary isometric strength of the quadriceps muscles will be measured with the HUMA® /NORM™ device.	Day 0
Maximum voluntary isokinetic strength of the quadriceps muscles at 240°/s (Nm).	Maximum voluntary isokinetic strength of the quadriceps muscles at 240°/s will be measured with the HUMA® /NORM™ device.	Day 0
Maximum voluntary isokinetic strength of the quadriceps muscles at 30°/s (eccentric contraction) (Nm).	Maximum voluntary isokinetic strength of the quadriceps muscles at 30°/s will be measured with the HUMA® /NORM™ device.	Day 0
Maximum voluntary isokinetic strength of the hamstring muscles at 60°/s (Nm).	Maximum voluntary isokinetic strength of the hamstring muscles at 60°/s will be measured with the HUMA® /NORM™ device.	Day 0
Maximum voluntary isokinetic strength of the hamstring muscles at 30°/s (eccentric contraction) (Nm).	Maximum voluntary isokinetic strength of the hamstring muscles at 30°/s will be measured with the HUMA® /NORM™ device.	Day 0
Maximal deflection (forward, backward left and right).	Maximal deflection will be measured with the STATIPRO® static posturography platform.	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	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).	Weight will be measured with the medical body weight scale SECA® and according to the ISAK recommendations.	Day 0
Weight (Kg).	Weight will be measured with the medical body weight scale SECA® and according to the ISAK recommendations.	Month 6
Weight (Kg).	Weight will be measured with the medical body weight scale SECA® and according to the ISAK recommendations.	Year 1
Weight (Kg).	Weight will be measured with the medical body weight scale SECA® and according to the ISAK recommendations.	Year 2
Weight (Kg).	Weight will be measured with the medical body weight scale SECA® and according to the ISAK recommendations.	Year 5
Height (cm).	Height will be measured with a wall mounted tape measure and according to the ISAK recommendations	Day 0
Height (cm).	Height will be measured with a wall mounted tape measure and according to the ISAK recommendations	Month 6
Height (cm).	Height will be measured with a wall mounted tape measure and according to the ISAK recommendations	Year 1
Height (cm).	Height will be measured with a wall mounted tape measure and according to the ISAK recommendations	Year 2
Height (cm).	Height will be measured with a wall mounted tape measure and according to the ISAK recommendations	Year 5
Body fat percentage (%).	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 (%).	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 (%).	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 (%).	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 (%).	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).	Waist circumference will be measured with a medical body tape measure and according to the ISAK recommendations	Day 0
Waist circumference (cm).	Waist circumference will be measured with a medical body tape measure and according to the ISAK recommendations	Month 5
Waist circumference (cm).	Waist circumference will be measured with a medical body tape measure and according to the ISAK recommendations	Year 1
Waist circumference (cm).	Waist circumference will be measured with a medical body tape measure and according to the ISAK recommendations	Year 2
Waist circumference (cm).	Waist circumference will be measured with a medical body tape measure and according to the ISAK recommendations	Year 5
Hip circumference (cm).	Hip circumference will be measured with a medical body tape measure and according to the ISAK recommendations.	Day 0
Hip circumference (cm).	Hip circumference will be measured with a medical body tape measure and according to the ISAK recommendations.	Month 6
Hip circumference (cm).	Hip circumference will be measured with a medical body tape measure and according to the ISAK recommendations.	Year 1
Hip circumference (cm).	Hip circumference will be measured with a medical body tape measure and according to the ISAK recommendations.	Year 2
Hip circumference (cm).	Hip circumference will be measured with a medical body tape measure and according to the ISAK recommendations.	Year 5
Brachial circumference (cm).	Brachial circumference will be measured with a medical body tape measure and according to the ISAK recommendations.	Day 0
Brachial circumference (cm).	Brachial circumference will be measured with a medical body tape measure and according to the ISAK recommendations.	Month 6
Brachial circumference (cm).	Brachial circumference will be measured with a medical body tape measure and according to the ISAK recommendations.	Year 1
Brachial circumference (cm).	Brachial circumference will be measured with a medical body tape measure and according to the ISAK recommendations.	Year 2
Brachial circumference (cm).	Brachial circumference will be measured with a medical body tape measure and according to the ISAK recommendations.	Year 5
Calf circumference (cm).	Calf circumference will be measured with a medical body tape measure and according to the ISAK recommendations	Day 0
Calf circumference (cm).	Calf circumference will be measured with a medical body tape measure and according to the ISAK recommendations	Month 6
Calf circumference (cm).	Calf circumference will be measured with a medical body tape measure and according to the ISAK recommendations	Year 1
Calf circumference (cm).	Calf circumference will be measured with a medical body tape measure and according to the ISAK recommendations	Year 2
Calf circumference (cm).	Calf circumference will be measured with a medical body tape measure and according to the ISAK recommendations	Year 5
Body Mass Index (Kg/m²).	BMI will be calculated (weight in kilograms divided by height in meters squared).	Day 0
Body Mass Index (Kg/m²).	BMI will be calculated (weight in kilograms divided by height in meters squared).	Month 6
Body Mass Index (Kg/m²).	BMI will be calculated (weight in kilograms divided by height in meters squared).	Year 1
Body Mass Index (Kg/m²).	BMI will be calculated (weight in kilograms divided by height in meters squared).	Year 2
Body Mass Index (Kg/m²).	BMI will be calculated (weight in kilograms divided by height in meters squared).	Year 5
Body composition	Body composition (muscle and fat) will be measured using he Bodystat® Impedance-meter.	Day 0
Body composition	Body composition (muscle and fat) will be measured using he Bodystat® Impedance-meter.	Month 6
Body composition	Body composition (muscle and fat) will be measured using he Bodystat® Impedance-meter.	Year 1
Body composition	Body composition (muscle and fat) will be measured using he Bodystat® Impedance-meter.	Year 2
Body composition	Body composition (muscle and fat) will be measured using he Bodystat® Impedance-meter.	Year 5
T-score (DS).	- Description: T-score will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.	DAy 0
T-score (DS).	- Description: T-score will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.	Month 6
T-score (DS).	- Description: T-score will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.	Year 1
T-score (DS).	- Description: T-score will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.	Year 2
T-score (DS).	- Description: T-score will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.	Year 5
Z-score (DS).	Z-score will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer	Day 0
Z-score (DS).	Z-score will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer	Month 6
Z-score (DS).	Z-score will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer	Year 1
Z-score (DS).	Z-score will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer	Year 2
Z-score (DS).	Z-score will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer	Year 5
Fat mass	Fat mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.	Day 0
Fat mass	Fat mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.	Month 6
Fat mass	Fat mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.	Year 1
Fat mass	Fat mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.	Year 2
Fat mass	Fat mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.	Year 5
Fat-free mass (%).	: Fat free mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.	Day 0
Fat-free mass (%).	: Fat free mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.	Month 6
Fat-free mass (%).	: Fat free mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.	Year 1
Fat-free mass (%).	: Fat free mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.	Year 2
Fat-free mass (%).	: Fat free mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.	Year 5
Fat mas index (Kg/m²).	Fat mas index will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.	Day 0
Fat mas index (Kg/m²).	Fat mas index will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.	Month 6
Fat mas index (Kg/m²).	Fat mas index will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.	Year 1
Fat mas index (Kg/m²).	Fat mas index will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.	Year 2
Fat mas index (Kg/m²).	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.	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.	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.	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.	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.	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).	Visceral fat mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.	Day 0
Visceral adipose tissue (Kg).	Visceral fat mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.	Month 6
Visceral adipose tissue (Kg).	Visceral fat mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.	Year 1
Visceral adipose tissue (Kg).	Visceral fat mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.	Year 2
Visceral adipose tissue (Kg).	Visceral fat mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.	Year 5
Fat-free mass index (kg/m²).	: 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).	: 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).	: 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).	: 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).	: 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).	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).	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).	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).	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).	Appendicular fat-free mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.	Year 5
Bone mass (Kg)	- Description: Bone mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.	Day 0
Bone mass (Kg)	- Description: Bone mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.	Month 6
Bone mass (Kg)	- Description: Bone mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.	Year 1
Bone mass (Kg)	- Description: Bone mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.	Year 2
Bone mass (Kg)	- Description: Bone mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.	Year 5
Daily caloric intake (Kcal/24h).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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	Nutritional status assessment will be assessed with the Mini Nutritional Assessment Questionnaire.	Day 0
Nutritional status assessment	Nutritional status assessment will be assessed with the Mini Nutritional Assessment Questionnaire.	Month 6
Nutritional status assessment	Nutritional status assessment will be assessed with the Mini Nutritional Assessment Questionnaire.	Year 1
Nutritional status assessment	Nutritional status assessment will be assessed with the Mini Nutritional Assessment Questionnaire.	Year 2
Nutritional status assessment	Nutritional status assessment will be assessed with the Mini Nutritional Assessment Questionnaire.	Year 5
Risk of undernutrition.	Risk of undernutrition will be assessed with the Brocker Questionnaire	Day 0
Risk of undernutrition.	Risk of undernutrition will be assessed with the Brocker Questionnaire	Month 6
Risk of undernutrition.	Risk of undernutrition will be assessed with the Brocker Questionnaire	Year 1
Risk of undernutrition.	Risk of undernutrition will be assessed with the Brocker Questionnaire	Year 2
Risk of undernutrition.	Risk of undernutrition will be assessed with the Brocker Questionnaire	Year 5
Basic biology.	: Basic biology will be measured using endocrine assays (fasting blood glucose, HbA1c, HDL-c and LDL-c, TG, CPK)	Day 0
Basic biology.	: Basic biology will be measured using endocrine assays (fasting blood glucose, HbA1c, HDL-c and LDL-c, TG, CPK)	Month 6
Basic biology.	: Basic biology will be measured using endocrine assays (fasting blood glucose, HbA1c, HDL-c and LDL-c, TG, CPK)	Year 1
Basic biology.	: Basic biology will be measured using endocrine assays (fasting blood glucose, HbA1c, HDL-c and LDL-c, TG, CPK)	Year 2
Basic biology.	: 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).	: 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).	: 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).	: 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).	: 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).	- 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).	- 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).	- 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).	- 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).	- 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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	- 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).	- 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).	- 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).	- 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).	- 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).	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).	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).	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).	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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	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	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	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	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	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	- 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	- 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	- 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	- 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	- 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).	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).	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).	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).	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).	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).	Maximum voluntary pinch strength will be measured with the Baseline® pinch gauche test mechanical dynamometer.	Day 0
Maximum voluntary pinch strength (Kg).	Maximum voluntary pinch strength will be measured with the Baseline® pinch gauche test mechanical dynamometer.	Month 6
Maximum voluntary pinch strength (Kg).	Maximum voluntary pinch strength will be measured with the Baseline® pinch gauche test mechanical dynamometer.	Year 1
Maximum voluntary pinch strength (Kg).	Maximum voluntary pinch strength will be measured with the Baseline® pinch gauche test mechanical dynamometer.	Year 2
Maximum voluntary pinch strength (Kg).	Maximum voluntary pinch strength will be measured with the Baseline® pinch gauche test mechanical dynamometer.	Year 5
Hip passive joint range	Hip joint range will be measured with a medical goniometer.	Day 0
Hip passive joint range	Hip joint range will be measured with a medical goniometer.	Month 6
Hip passive joint range	Hip joint range will be measured with a medical goniometer.	Year 1
Hip passive joint range	Hip joint range will be measured with a medical goniometer.	Year 2
Hip passive joint range	Hip joint range will be measured with a medical goniometer.	Year 5
Knee passive joint range.	Knee joint range will be measured with a medical goniometer.	Day 0
Knee passive joint range.	Knee joint range will be measured with a medical goniometer.	Month 6
Knee passive joint range.	Knee joint range will be measured with a medical goniometer.	Year 1
Knee passive joint range.	Knee joint range will be measured with a medical goniometer.	Year 2
Knee passive joint range.	Knee joint range will be measured with a medical goniometer.	Year 5
Ankle passive joint range	Ankle joint range will be measured with a medical goniometer.	Day 0
Ankle passive joint range	Ankle joint range will be measured with a medical goniometer.	Month 6
Ankle passive joint range	Ankle joint range will be measured with a medical goniometer.	Year 1
Ankle passive joint range	Ankle joint range will be measured with a medical goniometer.	Year 2
Ankle passive joint range	Ankle joint range will be measured with a medical goniometer.	Year 5
Lower and upper limb muscle power assessment (MRC)	Lower and upper limb muscle power assessment will be performed by an experienced physician.	Day 0
Lower and upper limb muscle power assessment (MRC)	Lower and upper limb muscle power assessment will be performed by an experienced physician.	Month 6
Lower and upper limb muscle power assessment (MRC)	Lower and upper limb muscle power assessment will be performed by an experienced physician.	Year 1
Lower and upper limb muscle power assessment (MRC)	Lower and upper limb muscle power assessment will be performed by an experienced physician.	Year 2
Lower and upper limb muscle power assessment (MRC)	Lower and upper limb muscle power assessment will be performed by an experienced physician.	Year 5
Statokinesigram surface area (mm²)	Statokinesigram surface area will be measured with the STATIPRO® static posturography platform.	Day 0
Statokinesigram surface area (mm²)	Statokinesigram surface area will be measured with the STATIPRO® static posturography platform.	Month 6
Statokinesigram surface area (mm²)	Statokinesigram surface area will be measured with the STATIPRO® static posturography platform.	Year 1
Statokinesigram surface area (mm²)	Statokinesigram surface area will be measured with the STATIPRO® static posturography platform.	Year 2
Statokinesigram surface area (mm²)	Statokinesigram surface area will be measured with the STATIPRO® static posturography platform.	Year 5
Stabilogram length (mm).	Stabilogram length will be measured with the STATIPRO® static posturography platform	Day 0
Stabilogram length (mm).	Stabilogram length will be measured with the STATIPRO® static posturography platform	Month 6
Stabilogram length (mm).	Stabilogram length will be measured with the STATIPRO® static posturography platform	Year 1
Stabilogram length (mm).	Stabilogram length will be measured with the STATIPRO® static posturography platform	Year 2
Stabilogram length (mm).	Stabilogram length will be measured with the STATIPRO® static posturography platform	Year 5
Maximal deflection (forward, backward left and right).	Maximal deflection will be measured with the STATIPRO® static posturography platform.	Month 6
Maximal deflection (forward, backward left and right).	Maximal deflection will be measured with the STATIPRO® static posturography platform.	Year 1
Maximal deflection (forward, backward left and right).	Maximal deflection will be measured with the STATIPRO® static posturography platform.	Year 2
Maximal deflection (forward, backward left and right).	Maximal deflection will be measured with the STATIPRO® static posturography platform.	Year 5
Velocity variations (mm/s).	: Velocity variations will be measured with the STATIPRO® static posturography platform.	Day 0
Velocity variations (mm/s).	: Velocity variations will be measured with the STATIPRO® static posturography platform.	Month 6
Velocity variations (mm/s).	: Velocity variations will be measured with the STATIPRO® static posturography platform.	Year 1
Velocity variations (mm/s).	: Velocity variations will be measured with the STATIPRO® static posturography platform.	Year 2
Velocity variations (mm/s).	: Velocity variations will be measured with the STATIPRO® static posturography platform.	Year 5
: Romberg ratio according to sway area	Romberg ratio will be measured with the STATIPRO® static posturography platform.	Day 0
: Romberg ratio according to sway area	Romberg ratio will be measured with the STATIPRO® static posturography platform.	Month 6
: Romberg ratio according to sway area	Romberg ratio will be measured with the STATIPRO® static posturography platform.	Year 1
: Romberg ratio according to sway area	Romberg ratio will be measured with the STATIPRO® static posturography platform.	Year 2
: Romberg ratio according to sway area	Romberg ratio will be measured with the STATIPRO® static posturography platform.	Year 5
Romberg ratio according to center of pressure path length	Romberg ratio will be measured with the STATIPRO® static posturography platform.	Day 0
Romberg ratio according to center of pressure path length	Romberg ratio will be measured with the STATIPRO® static posturography platform.	Month 6
Romberg ratio according to center of pressure path length	Romberg ratio will be measured with the STATIPRO® static posturography platform.	Year 1
Romberg ratio according to center of pressure path length	Romberg ratio will be measured with the STATIPRO® static posturography platform.	Year 2
Romberg ratio according to center of pressure path length	Romberg ratio will be measured with the STATIPRO® static posturography platform.	Year 5
: Plantar pressure ratio sway area.	Plantar pressure ratio sway area will be measured with the STATIPRO® static posturography platform.	Day 0
: Plantar pressure ratio sway area.	Plantar pressure ratio sway area will be measured with the STATIPRO® static posturography platform.	Month 6
: Plantar pressure ratio sway area.	Plantar pressure ratio sway area will be measured with the STATIPRO® static posturography platform.	Year 1
: Plantar pressure ratio sway area.	Plantar pressure ratio sway area will be measured with the STATIPRO® static posturography platform.	Year 2
: Plantar pressure ratio sway area.	Plantar pressure ratio sway area will be measured with the STATIPRO® static posturography platform.	Year 5
Plantar pressure ratio length.	Plantar pressure ratio length will be measured with the STATIPRO® static posturography platform.	Day 0
Plantar pressure ratio length.	Plantar pressure ratio length will be measured with the STATIPRO® static posturography platform.	Month 6
Plantar pressure ratio length.	Plantar pressure ratio length will be measured with the STATIPRO® static posturography platform.	Year 1
Plantar pressure ratio length.	Plantar pressure ratio length will be measured with the STATIPRO® static posturography platform.	Year 2
Plantar pressure ratio length.	Plantar pressure ratio length will be measured with the STATIPRO® static posturography platform.	Year 5
Walking velocity (cm/s).	Walking velocity will be measured with the GAITRite® Electronic Walkway.	Day 0
Walking velocity (cm/s).	Walking velocity will be measured with the GAITRite® Electronic Walkway.	Month 6
Walking velocity (cm/s).	Walking velocity will be measured with the GAITRite® Electronic Walkway.	Year 1
Walking velocity (cm/s).	Walking velocity will be measured with the GAITRite® Electronic Walkway.	Year 2
Walking velocity (cm/s).	Walking velocity will be measured with the GAITRite® Electronic Walkway.	Year 5
Cadence (steps/min).	: Cadence will be measured with the GAITRite® Electronic Walkway.	Day 0
Cadence (steps/min).	: Cadence will be measured with the GAITRite® Electronic Walkway.	Month 6
Cadence (steps/min).	: Cadence will be measured with the GAITRite® Electronic Walkway.	Year 1
Cadence (steps/min).	: Cadence will be measured with the GAITRite® Electronic Walkway.	Year 2
Cadence (steps/min).	: Cadence will be measured with the GAITRite® Electronic Walkway.	Year 5
Step length (left and right foot) (cm)	Step length will be measured with the GAITRite® Electronic Walkway.	DAy 0
Step length (left and right foot) (cm)	Step length will be measured with the GAITRite® Electronic Walkway.	Month 6
Step length (left and right foot) (cm)	Step length will be measured with the GAITRite® Electronic Walkway.	Year 1
Step length (left and right foot) (cm)	Step length will be measured with the GAITRite® Electronic Walkway.	Year 2
Step length (left and right foot) (cm)	Step length will be measured with the GAITRite® Electronic Walkway.	Year 5
Stride length (cm).	Stride length will be measured with the GAITRite® Electronic Walkway.	Day 0
Stride length (cm).	Stride length will be measured with the GAITRite® Electronic Walkway.	month 6
Stride length (cm).	Stride length will be measured with the GAITRite® Electronic Walkway.	year 1
Stride length (cm).	Stride length will be measured with the GAITRite® Electronic Walkway.	year 2
Stride length (cm).	Stride length will be measured with the GAITRite® Electronic Walkway.	year 5
Single support time left and right foot (s).	Single support time will be measured with the GAITRite® Electronic Walkway.	Day 0
Single support time left and right foot (s).	Single support time will be measured with the GAITRite® Electronic Walkway.	Month 6
Single support time left and right foot (s).	Single support time will be measured with the GAITRite® Electronic Walkway.	Year 1
Single support time left and right foot (s).	Single support time will be measured with the GAITRite® Electronic Walkway.	Year 2
Single support time left and right foot (s).	Single support time will be measured with the GAITRite® Electronic Walkway.	Year 5
Double support time (s).	: Double support time will be measured with the GAITRite® Electronic Walkway.	Day 0
Double support time (s).	: Double support time will be measured with the GAITRite® Electronic Walkway.	Month 6
Double support time (s).	: Double support time will be measured with the GAITRite® Electronic Walkway.	YEar 1
Double support time (s).	: Double support time will be measured with the GAITRite® Electronic Walkway.	Year 2
Double support time (s).	: Double support time will be measured with the GAITRite® Electronic Walkway.	Year 5
Swing time (s).	: Swing time will be measured with the GAITRite® Electronic Walkway.	Day 0
Swing time (s).	: Swing time will be measured with the GAITRite® Electronic Walkway.	Month 6
Swing time (s).	: Swing time will be measured with the GAITRite® Electronic Walkway.	Year 1
Swing time (s).	: Swing time will be measured with the GAITRite® Electronic Walkway.	Year 2
Swing time (s).	: Swing time will be measured with the GAITRite® Electronic Walkway.	Year 5
Swing phase (as a % of walking cycle).	: Swing phase will be measured with the GAITRite® Electronic Walkway.	DAy 0
Swing phase (as a % of walking cycle).	: Swing phase will be measured with the GAITRite® Electronic Walkway.	Month 6
Swing phase (as a % of walking cycle).	: Swing phase will be measured with the GAITRite® Electronic Walkway.	Year 1
Swing phase (as a % of walking cycle).	: Swing phase will be measured with the GAITRite® Electronic Walkway.	Year 2
Swing phase (as a % of walking cycle).	: Swing phase will be measured with the GAITRite® Electronic Walkway.	Year 5
Stance phase (as a % of walking cycle).	Stance phase will be measured with the GAITRite® Electronic Walkway.	Day 0
Stance phase (as a % of walking cycle).	Stance phase will be measured with the GAITRite® Electronic Walkway.	Month 6
Stance phase (as a % of walking cycle).	Stance phase will be measured with the GAITRite® Electronic Walkway.	Year 1
Stance phase (as a % of walking cycle).	Stance phase will be measured with the GAITRite® Electronic Walkway.	Year 2
Stance phase (as a % of walking cycle).	Stance phase will be measured with the GAITRite® Electronic Walkway.	Year 5
Vo2max (maximal oxygen consumption) (mL/Kg/min).	: 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).	: 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).	: 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).	: 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).	: 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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	: Forced vital Capacity will be measured with a spirometry test.	Day 0
Forced vital Capacity (L).	: Forced vital Capacity will be measured with a spirometry test.	Month 6
Forced vital Capacity (L).	: Forced vital Capacity will be measured with a spirometry test.	Year 1
Forced vital Capacity (L).	: Forced vital Capacity will be measured with a spirometry test.	Year 2
Forced vital Capacity (L).	: Forced vital Capacity will be measured with a spirometry test.	Year 5
Forced Expiratory volume (L)	Forced Expiratory volume will be measured with a spirometry test.	Day 0
Forced Expiratory volume (L)	Forced Expiratory volume will be measured with a spirometry test.	Month 6
Forced Expiratory volume (L)	Forced Expiratory volume will be measured with a spirometry test.	Year 1
Forced Expiratory volume (L)	Forced Expiratory volume will be measured with a spirometry test.	Year 2
Forced Expiratory volume (L)	Forced Expiratory volume will be measured with a spirometry test.	Year 5
Tiffeneau ratio (%).	Tiffeneau ratio will be calculated by dividing the Forced Expiratory volume to the Forced vital Capacity.	Day 0
Tiffeneau ratio (%).	Tiffeneau ratio will be calculated by dividing the Forced Expiratory volume to the Forced vital Capacity.	Month 6
Tiffeneau ratio (%).	Tiffeneau ratio will be calculated by dividing the Forced Expiratory volume to the Forced vital Capacity.	Year 1
Tiffeneau ratio (%).	Tiffeneau ratio will be calculated by dividing the Forced Expiratory volume to the Forced vital Capacity.	Year 2
Tiffeneau ratio (%).	Tiffeneau ratio will be calculated by dividing the Forced Expiratory volume to the Forced vital Capacity.	Year 5
Ventilatory reserve (%).	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 (%).	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 (%).	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 (%).	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 (%).	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	Physical activity will be measured using the Global Physical Activity Questionnaire (GPAQ)	Day 0
Physical activity	Physical activity will be measured using the Global Physical Activity Questionnaire (GPAQ)	Month 6
Physical activity	Physical activity will be measured using the Global Physical Activity Questionnaire (GPAQ)	Year 1
Physical activity	Physical activity will be measured using the Global Physical Activity Questionnaire (GPAQ)	Year 2
Physical activity	Physical activity will be measured using the Global Physical Activity Questionnaire (GPAQ)	Year 5
Functional capacity timed-up and go	Functional capacity will be evaluated using the Timed-Up and Go test.	Day 0
Functional capacity timed-up and go	Functional capacity will be evaluated using the Timed-Up and Go test.	Month 6
Functional capacity timed-up and go	Functional capacity will be evaluated using the Timed-Up and Go test.	Year 1
Functional capacity timed-up and go	Functional capacity will be evaluated using the Timed-Up and Go test.	Year 2
Functional capacity timed-up and go	Functional capacity will be evaluated using the Timed-Up and Go test.	Year 5
Functional capacity TDM6	Functional capacity will be evaluated using the 6-minute walk test.	Day 0
Functional capacity TDM6	Functional capacity will be evaluated using the 6-minute walk test.	Month 6
Functional capacity TDM6	Functional capacity will be evaluated using the 6-minute walk test.	Year 1
Functional capacity TDM6	Functional capacity will be evaluated using the 6-minute walk test.	Year 2
Functional capacity TDM6	Functional capacity will be evaluated using the 6-minute walk test.	Year 5
Functional capacity Five Times Sit to Stand test.	Functional capacity will be evaluated using the Five Times Sit to Stand test.	Day 0
Functional capacity Five Times Sit to Stand test.	Functional capacity will be evaluated using the Five Times Sit to Stand test.	Month 6
Functional capacity Five Times Sit to Stand test.	Functional capacity will be evaluated using the Five Times Sit to Stand test.	Year 1
Functional capacity Five Times Sit to Stand test.	Functional capacity will be evaluated using the Five Times Sit to Stand test.	Year 2
Functional capacity Five Times Sit to Stand test.	Functional capacity will be evaluated using the Five Times Sit to Stand test.	Year 5
Functional capacity SPPB	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	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	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	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	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.	Functional capacity will be evaluated using the mini-BESTest.	Day 0
Functional capacity the mini-BESTest.	Functional capacity will be evaluated using the mini-BESTest.	Month 6
Functional capacity the mini-BESTest.	Functional capacity will be evaluated using the mini-BESTest.	Year 1
Functional capacity the mini-BESTest.	Functional capacity will be evaluated using the mini-BESTest.	Year 2
Functional capacity the mini-BESTest.	Functional capacity will be evaluated using the mini-BESTest.	Year 5
Functional capacity Berg Balance Scale.	Functional capacity will be evaluated using the Berg Balance Scale.	Day 0
Functional capacity Berg Balance Scale.	Functional capacity will be evaluated using the Berg Balance Scale.	Month 6
Functional capacity Berg Balance Scale.	Functional capacity will be evaluated using the Berg Balance Scale.	Year 1
Functional capacity Berg Balance Scale.	Functional capacity will be evaluated using the Berg Balance Scale.	Year 2
Functional capacity Berg Balance Scale.	Functional capacity will be evaluated using the Berg Balance Scale.	Year 5
Functional capacity 10-meter walk test	Functional capacity will be evaluated using the 10-meter walk test (at usual and maximal pace).	Day 0
Functional capacity 10-meter walk test	Functional capacity will be evaluated using the 10-meter walk test (at usual and maximal pace).	Month 6
Functional capacity 10-meter walk test	Functional capacity will be evaluated using the 10-meter walk test (at usual and maximal pace).	Year 1
Functional capacity 10-meter walk test	Functional capacity will be evaluated using the 10-meter walk test (at usual and maximal pace).	Year 2
Functional capacity 10-meter walk test	Functional capacity will be evaluated using the 10-meter walk test (at usual and maximal pace).	Year 5
Dyspnea	Dyspnea will be evaluated by a Numeric Rating scale ranging from 0 to 10.	Day 0
Dyspnea	Dyspnea will be evaluated by a Numeric Rating scale ranging from 0 to 10.	Month 6
Dyspnea	Dyspnea will be evaluated by a Numeric Rating scale ranging from 0 to 10.	Year 1
Dyspnea	Dyspnea will be evaluated by a Numeric Rating scale ranging from 0 to 10.	Year 2
Dyspnea	Dyspnea will be evaluated by a Numeric Rating scale ranging from 0 to 10.	Year 5
Perceived exertion before, during and after effort	Perceived exertion will be evaluated by a Numeric Rating scale ranging from 0 to 10.	DAy 0
Perceived exertion before, during and after effort	Perceived exertion will be evaluated by a Numeric Rating scale ranging from 0 to 10.	Month 6
Perceived exertion before, during and after effort	Perceived exertion will be evaluated by a Numeric Rating scale ranging from 0 to 10.	Year 1
Perceived exertion before, during and after effort	Perceived exertion will be evaluated by a Numeric Rating scale ranging from 0 to 10.	Year 2
Perceived exertion before, during and after effort	Perceived exertion will be evaluated by a Numeric Rating scale ranging from 0 to 10.	Year 5
Pain	: 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	: 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	: 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	: 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	: 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	Sarcopenia risk will be evaluated with the SARC-F Questionnaire.	Day 0
Sarcopenia risk	Sarcopenia risk will be evaluated with the SARC-F Questionnaire.	Month 6
Sarcopenia risk	Sarcopenia risk will be evaluated with the SARC-F Questionnaire.	Year 1
Sarcopenia risk	Sarcopenia risk will be evaluated with the SARC-F Questionnaire.	Year 2
Sarcopenia risk	Sarcopenia risk will be evaluated with the SARC-F Questionnaire.	Year 5
Social insecurity	Social insecurity will be evaluated with the EPICES Score Questionnaire.	Day 0
Social insecurity	Social insecurity will be evaluated with the EPICES Score Questionnaire.	Month 6
Social insecurity	Social insecurity will be evaluated with the EPICES Score Questionnaire.	Year 1
Social insecurity	Social insecurity will be evaluated with the EPICES Score Questionnaire.	Year 2
Social insecurity	Social insecurity will be evaluated with the EPICES Score Questionnaire.	Year 5
Kinesiophobia	Kinesiophobia will be evaluated with the TAMPA Scale.	Day 0
Kinesiophobia	Kinesiophobia will be evaluated with the TAMPA Scale.	Month 6
Kinesiophobia	Kinesiophobia will be evaluated with the TAMPA Scale.	Year 1
Kinesiophobia	Kinesiophobia will be evaluated with the TAMPA Scale.	Year 2
Kinesiophobia	Kinesiophobia will be evaluated with the TAMPA Scale.	Year 5
Quality of life	Quality of life will be evaluated with the 36-Item Short Form Survey.	Day 0
Quality of life	Quality of life will be evaluated with the 36-Item Short Form Survey.	Month 6
Quality of life	Quality of life will be evaluated with the 36-Item Short Form Survey.	Year 1
Quality of life	Quality of life will be evaluated with the 36-Item Short Form Survey.	Year 2
Quality of life	Quality of life will be evaluated with the 36-Item Short Form Survey.	Year 5
: Balance confidence in performing various activities	Self-report balance confidence will be evaluated with the Activities-specific Balance Confidence (ABC) Scale.vey.	Day 0
: Balance confidence in performing various activities	Self-report balance confidence will be evaluated with the Activities-specific Balance Confidence (ABC) Scale.vey.	Month 6
: Balance confidence in performing various activities	Self-report balance confidence will be evaluated with the Activities-specific Balance Confidence (ABC) Scale.vey.	Year 1
: Balance confidence in performing various activities	Self-report balance confidence will be evaluated with the Activities-specific Balance Confidence (ABC) Scale.vey.	Year 2
: Balance confidence in performing various activities	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.	Functioning will be evaluated with the Lawton Instrumental Activities of Daily Living (IADL) Scale.	Day 0
Functioning in regards to activities of daily living.	Functioning will be evaluated with the Lawton Instrumental Activities of Daily Living (IADL) Scale.	Month 6
Functioning in regards to activities of daily living.	Functioning will be evaluated with the Lawton Instrumental Activities of Daily Living (IADL) Scale.	Year 1
Functioning in regards to activities of daily living.	Functioning will be evaluated with the Lawton Instrumental Activities of Daily Living (IADL) Scale.	Year 2
Functioning in regards to activities of daily living.	Functioning will be evaluated with the Lawton Instrumental Activities of Daily Living (IADL) Scale.	Year 5
Exhaustion	Exhaustion will be evaluated with the FACIT-F Questionnaire.	Day 0
Exhaustion	Exhaustion will be evaluated with the FACIT-F Questionnaire.	Month 6
Exhaustion	Exhaustion will be evaluated with the FACIT-F Questionnaire.	Year 1
Exhaustion	Exhaustion will be evaluated with the FACIT-F Questionnaire.	Year 2
Exhaustion	Exhaustion will be evaluated with the FACIT-F Questionnaire.	Year 5
Patient's opinion about their knee and associated problems	: Outcomes will be evaluated with the Knee Injury and Osteoarthritis Outcome Score (KOOS).	Day 0
Patient's opinion about their knee and associated problems	: Outcomes will be evaluated with the Knee Injury and Osteoarthritis Outcome Score (KOOS).	Month 6
Patient's opinion about their knee and associated problems	: Outcomes will be evaluated with the Knee Injury and Osteoarthritis Outcome Score (KOOS).	Year 1
Patient's opinion about their knee and associated problems	: Outcomes will be evaluated with the Knee Injury and Osteoarthritis Outcome Score (KOOS).	Year 2
Patient's opinion about their knee and associated problems	: Outcomes will be evaluated with the Knee Injury and Osteoarthritis Outcome Score (KOOS).	Year 5
Patient's opinion about their hip and associated problems	Outcomes will be evaluated with the Hip Injury and Osteoarthritis Outcome Score (HOOS).	Day 0
Patient's opinion about their hip and associated problems	Outcomes will be evaluated with the Hip Injury and Osteoarthritis Outcome Score (HOOS).	Month 6
Patient's opinion about their hip and associated problems	Outcomes will be evaluated with the Hip Injury and Osteoarthritis Outcome Score (HOOS).	Year 1
Patient's opinion about their hip and associated problems	Outcomes will be evaluated with the Hip Injury and Osteoarthritis Outcome Score (HOOS).	Year 2
Patient's opinion about their hip and associated problems	Outcomes will be evaluated with the Hip Injury and Osteoarthritis Outcome Score (HOOS).	Year 5
Predicting discharge destination after total joint arthroplasty.	: Discharge destination will be evaluated with the Risk Assessment and Prediction Tool (RAPT);	Day 0
Predicting discharge destination after total joint arthroplasty.	: Discharge destination will be evaluated with the Risk Assessment and Prediction Tool (RAPT);	Month 6
Physical function in myositis patients	Physical function will be evaluated with the Stanford Health Assessment Questionnaire.	Day 0
Physical function in myositis patients	Physical function will be evaluated with the Stanford Health Assessment Questionnaire.	Month 6
Physical function in myositis patients	Physical function will be evaluated with the Stanford Health Assessment Questionnaire.	Year 1
Physical function in myositis patients	Physical function will be evaluated with the Stanford Health Assessment Questionnaire.	Year 2
Physical function in myositis patients	Physical function will be evaluated with the Stanford Health Assessment Questionnaire.	Year 5
Quality of life in Parkinson's Disease	Quality of life will be measured with the Parkinson's Disease Questionnaire-39 (PDQ-39).	Day 0
Quality of life in Parkinson's Disease	Quality of life will be measured with the Parkinson's Disease Questionnaire-39 (PDQ-39).	Month 6
Quality of life in Parkinson's Disease	Quality of life will be measured with the Parkinson's Disease Questionnaire-39 (PDQ-39).	Year 1
Quality of life in Parkinson's Disease	Quality of life will be measured with the Parkinson's Disease Questionnaire-39 (PDQ-39).	Year 2
Quality of life in Parkinson's Disease	Quality of life will be measured with the Parkinson's Disease Questionnaire-39 (PDQ-39).	Year 5
Actimetry.	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

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: I-SITE Cap 20-25 project
• Investigators: Principal Investigator: Frédéric Costes, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2020
• Primary Completion (Anticipated): September 1, 2030
• Study Completion (Anticipated): September 1, 2031

Study Registration Dates

• First Submitted: April 27, 2020
• First Submitted That Met QC Criteria: May 4, 2020
• First Posted (Actual): May 5, 2020

Study Record Updates

• Last Update Posted (Actual): August 28, 2020
• Last Update Submitted That Met QC Criteria: August 27, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Prevention; Risk factors; Mobility; Chronic pathologies; Activity limitations; Chronic illness; Altered mobility; Physical capacities; Physical test
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Respiratory Tract Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Lung Diseases; Disease Attributes; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Obesity; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Parkinson Disease; Chronic Disease; Atherosclerosis; Gangrene
• Other Study ID Numbers: RBHP 2019 COSTES; 2019-A01017-50 (Other Identifier: 2019-A01017-50)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No