- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03521752
Influence of an Exercise Program in the Elderly Balance
Influence of a Specific Exercise Program in the Institutionalized Elderly Balance
This study has the objective to determinate the effectiveness of a specific exercise program on balance and functional capacity of the daily activities of institutionalized elderly.
It was a randomized controlled trial with a total of 21 elderly that were randomly distributed into experimental (n = 11) and control groups (n=10). The experimental group performed a specific program exercises during 4 weeks, while the control group wasn't subjected to any intervention. Evaluations were carried out at the beginning and end of the exercise program, for both groups. After the intervention there were no statistically significant differences between groups in total balance and dynamic balance subscale, except static balance subscale.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Age ≥ 65 years
- institutionalized elderly
- Both genders
- Mini-Mental ≥19 pontos
- Protocol attendance ≥ 90%
Exclusion Criteria:
- Cardiovascular diseases
- Contraindication to physical exercise
- Medication (anxiolytics, antidepressants)
- Vestibular disorders
- Previous physiotherapy of 6 months to the present study
- Neurological and neuromuscular diseases
- Use of gaiters
- Another type of physical exercise during the study
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Experimental
Performed a specific program exercises (resistance training, balance, coordination and flexibility) during 4 weeks.
|
4 weeks of exercise classes, 2 to 3 times a week for a total of 10 sessions.
Classes last approximately 40 minutes.
The sessions included balance training, motor strength, endurance and flexibility.
The training sessions were divided into warm-up, main activity and finally relaxation.
|
|
Sin intervención: Control
The control group wasn't subjected to any intervention
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Balance
Periodo de tiempo: 4 weeks
|
Performance Oriented Mobility Assessment (POMA) This scale measures the static and dynamic balance, through the evaluation of some daily activities. This scale's scores are between 9 to 28 points, when 9 means hig risk of falling, and 28 means low risk of falling. It was used before and after the intervention. |
4 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Functional capacity
Periodo de tiempo: 4 weeks
|
Timed up and Go (TUG) This scale measures the mobility and locomotor performance, through the timing of an activity (lift from a chair, walk 3 meters, change direction and return to starting position). The cut-off points of the scale are divided into fully independent elderly (<10 seconds), independent elderly (10-19 seconds), and elderly people with difficulties in the tasks of daily living (20-29 seconds). It was evaluated before and after the intervention. |
4 weeks
|
Colaboradores e Investigadores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 1CESPU
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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