Obesity, Sarcopenic, Risk of Falls in Spanish Postmenopausal Women
9 de septiembre de 2021 actualizado por: Agustín Aibar Almazán, University of Jaén
Effects of a Program of Pilates Exercises on Obesity, Sarcopenic, Risk of Falls and Health in Spanish Postmenopausal Women
To analyze the effects of a Pilates exercise program on obesity, sarcopenic, risk of falls and health in Spanish postmenopausal women.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a randomized clinical trial of single-blind with 2 arms (Control group and experimental group), in which a pre-treatment-postest design has been used.
The study will define two groups:
- A control group (CG) that will not be submitted to treatment, which will be evaluated in the pre and post phase of the study. Participants assigned to this group will receive general advice on the positive effects of regular physical activity and will be given a guide to recommendations for promoting physical activity.
- An experimental group (GE) that after an initial evaluation will undergo a physical training program based on Pilates exercises.
Once the intervention is finished, it will be submitted to a final evaluation to see if there is a difference or not with the results obtained at the beginning.
Tipo de estudio
Intervencionista
Inscripción (Actual)
107
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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-
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Jaén, España, 23002
- Center of active participation of seniors of Jaén "Catedral"
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
50 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Femenino
Descripción
Inclusion Criteria:
- No menstrual activity for at least 12 months.
- Present obesity and / or sarcopenic.
- Do not participate in a weight loss program.
- Be able to understand the instructions, programs and protocols of this project.
Exclusion Criteria:
- Contraindications for conducting physical tests.
- Diseases that limit the static and dynamic balance and physical activity. -
- Central or peripheral vestibular or nerve alterations.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Grupo pilates
Este grupo recibe preparación física basada en ejercicios de pilates
|
Training based on a basic level Pilates exercise program will be as follows: A duration of weeks with a frequency of 2 sessions a week and with a duration of 55 minutes each. The exercises to be performed will be divided into three distinct phases: warm-up, lasting 15 minutes; Main part with a duration of 30 minutes and the return to calm, based mostly on stretching and with a duration of 10 minutes. The repetitions of the exercises will be between 5 and 10 according to the difficulty. |
|
Sin intervención: Sin grupo de intervención
Este grupo no recibe ningún tratamiento.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Masa muscular esquelética (kg)
Periodo de tiempo: Al principio y a los tres meses
|
Se calcula en función de la masa muscular de las extremidades, que está compuesta casi por músculo esquelético y ocupa alrededor del 70 % del músculo esquelético total del cuerpo.
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Al principio y a los tres meses
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TUG (prueba Timed Up and Go)
Periodo de tiempo: Al principio y a los tres meses
|
Es una prueba simple que se utiliza para evaluar la movilidad y la función física de una persona.
|
Al principio y a los tres meses
|
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X media
Periodo de tiempo: Al principio y a los tres meses
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Valor medio de las oscilaciones laterales del Centro de Presión
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Al principio y a los tres meses
|
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Y significa
Periodo de tiempo: Al principio y a los tres meses
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Valor medio de las oscilaciones anteroposteriores del Centro de Presión
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Al principio y a los tres meses
|
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Dynamometer
Periodo de tiempo: At the beginning and at three months
|
Dynamometer will be employed to assess hand grip stregth.
|
At the beginning and at three months
|
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ABC-16 (Activities Specific Balance Confidence Scale)
Periodo de tiempo: At the beginning and at three months
|
Questionnaire that assesses balance confidence in performing activities of daily living.
|
At the beginning and at three months
|
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FES-I (Falls Efficacy Scale-International)
Periodo de tiempo: At the beginning and at three months
|
Questionnaire that evaluates the fear of falling.
|
At the beginning and at three months
|
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Barthel index
Periodo de tiempo: At the beginning and at three months
|
Measures disability or dependence in activities of daily living
|
At the beginning and at three months
|
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KATZ INDEX
Periodo de tiempo: At the beginning and at three months
|
Is a widely used tool to assess the level of independency in older adults.
|
At the beginning and at three months
|
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FSS (Fatigue Severity Scale)
Periodo de tiempo: At the beginning and at three months
|
A self-report scale describing the severity of fatigue and the impact of fatigue on activities of daily living.
|
At the beginning and at three months
|
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PSQI (Pittsburgh Sleep Quality Index)
Periodo de tiempo: At the beginning and at three months
|
A simple and valid assessment of both sleep quality and disturbance that might affect sleep quality.
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At the beginning and at three months
|
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HADS (The Hospital Anxiety And Depression)
Periodo de tiempo: At the beginning and at three months
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A reliable, valid and practical screening tool for identifying and quantifying anxiety and/or depression in non- patients.
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At the beginning and at three months
|
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SF-36 (The Short Form-36 Health Survey)
Periodo de tiempo: At the beginning and at three months
|
Used extensively for assessing health-related quality of life.
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At the beginning and at three months
|
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MRS (Menopause Rating Scale):
Periodo de tiempo: At the beginning and at three months
|
Assesses the severity of menopause-related complaints and the impact on health-related quality of life.
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At the beginning and at three months
|
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FSFI (Female Sexual Function Index)
Periodo de tiempo: At the beginning and at three months
|
Is a brief questionnaire that evaluates sexual functioning in women.
|
At the beginning and at three months
|
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INBODY
Periodo de tiempo: At the beginning and at three months
|
Valid and reliable tool to quantify and measure the 4 major components of body composition: Water, Protein, Minerals and Fat.
|
At the beginning and at three months
|
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Bone Mineral Content (BMC)
Periodo de tiempo: At the beginning and at three months
|
Is mineral mass in bone.
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At the beginning and at three months
|
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Body Weight
Periodo de tiempo: At the beginning and at three months
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Is the sum of Body Fat and Fat Free Mass.
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At the beginning and at three months
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Lean Body Mass
Periodo de tiempo: At the beginning and at three months
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The amount of lean body mass.
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At the beginning and at three months
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Body Fat Mass
Periodo de tiempo: At the beginning and at three months
|
The standard range of Body Fat Mass is ascertained by calculating an examinee Body Fat Mass as compared to the standard weight and standard Body Fat Mass.
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At the beginning and at three months
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Percent of Body Fat (%)
Periodo de tiempo: At the beginning and at three months
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Indicates the percentage of body fat to body weight.
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At the beginning and at three months
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BMI (Body Mass Index)
Periodo de tiempo: At the beginning and at three months
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Is calculated from the formula, Weight (kg) / Height2 (m2), whose unit is kg/m2.
It is a rough indicator of total body fat.
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At the beginning and at three months
|
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Segmental Analysis
Periodo de tiempo: At the beginning and at three months
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Is the technology that assumes the body as five cylinders of four limbs and trunk and measures the impedance of these parts separately.
Segmental body composition analysis provides segmental measurement of body water, muscle mass, and fat free mass.
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At the beginning and at three months
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OPTOGAIT
Periodo de tiempo: At the beginning and at three months
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Is an innovative system for movement analysis and functional assessment of patients with normal or pathological conditions.
REACTION TEST: This test detects the time between one optical/acoustic impulse and the patient's movement.
It can be used to measure simple reactions or more complex movements
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At the beginning and at three months
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CT10P
Periodo de tiempo: At the beginning and at three months
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Test that evaluates the balance by walking along a straight line.
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At the beginning and at three months
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STABILOMETRIC PLATFORM
Periodo de tiempo: At the beginning and at three months
|
Instrument composed of resistive pressure sensors, used to measure the static or postural balance.
The test was performed under both eyes-open and eyes-closed conditions.
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At the beginning and at three months
|
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RMS X
Periodo de tiempo: At the beginning and at three months
|
Mean position of the center of pressure in the mediolateral plane.
|
At the beginning and at three months
|
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RMS Y
Periodo de tiempo: At the beginning and at three months
|
Mean position of the center of pressure in the anteroposterior plane
|
At the beginning and at three months
|
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Length
Periodo de tiempo: At the beginning and at three months
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Length of the path described by the center of pressure.
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At the beginning and at three months
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Area
Periodo de tiempo: At the beginning and at three months
|
Area of the path described by the center of pressure.
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At the beginning and at three months
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Velocity
Periodo de tiempo: At the beginning and at three months
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Is an estimate of the average velocity of displacement of the center of pressures of the subject during the whole test.
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At the beginning and at three months
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Isaac test
Periodo de tiempo: At the beginning and at three months
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Questionnaire that measures verbal fluency.
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At the beginning and at three months
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trail making test part a y b
Periodo de tiempo: At the beginning and at three months
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Neuropsychological test of visual attention and task switching.
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At the beginning and at three months
|
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mmse (mini-mental state examination)
Periodo de tiempo: At the beginning and at three months
|
A tool that can be used to systematically and thoroughly assess mental status.
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At the beginning and at three months
|
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chair sit and reach test
Periodo de tiempo: At the beginning and at three months
|
To test low back and hamstring flexibility.
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At the beginning and at three months
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back scratch test
Periodo de tiempo: At the beginning and at three months
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To measure general shoulder range of motion.
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At the beginning and at three months
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30-second chair stand test
Periodo de tiempo: At the beginning and at three months
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To test leg strength and endurance.
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At the beginning and at three months
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height
Periodo de tiempo: At the beginning and at three months
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The distance between the lowest and highest points of a person standing upright.
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At the beginning and at three months
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waist circumference
Periodo de tiempo: At the beginning and at three months
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Is used to assess central fat distribution and degree of abdominal obesity.
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At the beginning and at three months
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hip circumference
Periodo de tiempo: At the beginning and at three months
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It is the greatest circumference of hip
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At the beginning and at three months
|
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waist-to-hip ratio
Periodo de tiempo: At the beginning and at three months
|
Is the dimensionless ratio of the circumference of the waist to that of the hips.
This is calculated as waist measurement divided by hip measurement.
|
At the beginning and at three months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de agosto de 2017
Finalización primaria (Actual)
1 de noviembre de 2017
Finalización del estudio (Actual)
27 de febrero de 2018
Fechas de registro del estudio
Enviado por primera vez
22 de junio de 2017
Primero enviado que cumplió con los criterios de control de calidad
23 de junio de 2017
Publicado por primera vez (Actual)
28 de junio de 2017
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
16 de septiembre de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
9 de septiembre de 2021
Última verificación
1 de septiembre de 2021
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- UJaen
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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. .