- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07854860
Four-Week Multicomponent Exercise Program in Older Adults
Effects of a 4-Week Multicomponent Exercise Program on Physical Function and Body Composition in Older Adults: A Non-Randomised Controlled Trial
This study evaluated the effects of a four-week supervised multicomponent exercise program on physical function and body composition in older adults. Participants were allocated non-randomly to an intervention group or a control group based on their ability to attend the scheduled training sessions. The intervention group completed eight supervised 30-minute exercise sessions over four weeks, while the control group maintained their usual daily activity and did not begin a new exercise program. Physical function, muscle strength, gait, static balance, body mass, and body composition were assessed at baseline and after four weeks.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
This prospective, non-randomised controlled intervention study investigated the effects of a short-term multicomponent exercise program in older adults. Participants were allocated to either an intervention group or a control group according to their ability to attend the scheduled training sessions, primarily based on logistical factors such as place of residence and travel feasibility.
The intervention consisted of eight supervised 30-minute training sessions performed twice weekly for four weeks. The program included exercises targeting muscle strength, mobility, balance, coordination, and functional performance. Exercise volume was progressively increased during the second half of the intervention by increasing the number of repetitions and sets.
The control group received no additional exercise intervention and was instructed to maintain usual daily activity and not initiate a new exercise program during the study period. Assessments were performed at baseline and after four weeks and included muscle strength, functional mobility, gait, static balance, body mass, and body composition.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Gorzów Wielkopolski, Polonia, 66-400
- Poznan University of Physical Education, Faculty of Sport Sciences in Gorzow Wielkopolski
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
Age 55-90 years Ability to ambulate independently without assistance from another person Ability to complete the full study protocol, including baseline and final assessments and, for the intervention group, participation in the four-week exercise program Provision of written informed consent
Exclusion Criteria:
Medical contraindications to physical exertion Cardiovascular, respiratory, neurological, or musculoskeletal conditions that could prevent safe performance of the tests or exercises Musculoskeletal injury or surgery within the previous six months Substantial balance or gait impairments requiring continuous assistance from another person Cognitive impairment preventing comprehension of instructions
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Multicomponent Exercise
Participants completed a four-week supervised multicomponent exercise program consisting of eight 30-minute sessions performed twice weekly. |
A supervised four-week multicomponent exercise program comprising eight 30-minute sessions performed twice weekly. The program included handgrip squeezing with a soft ball, hip flexion with a resistance band, glute bridges, single-leg stance with multidirectional reaching, supine trunk rotation, cervical spine mobility exercises, and stepping over an obstacle. The program was divided into two stages, with progression during weeks 3-4 achieved by increasing the number of repetitions and sets. |
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Sin intervención: Control
Participants received no additional exercise intervention between assessments and were instructed to maintain their usual daily activity levels and not begin a new exercise program. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Handgrip Strength
Periodo de tiempo: Baseline to 4 weeks
|
Change in mean bilateral handgrip strength measured with a digital hand dynamometer, expressed in kg. |
Baseline to 4 weeks
|
|
Change in Isometric Hip Flexion Strength
Periodo de tiempo: Baseline to 4 weeks
|
Change in mean bilateral isometric hip flexion strength measured using an EasyForce dynamometer, expressed in kg. |
Baseline to 4 weeks
|
|
Change in Isometric Hip Extension Strength
Periodo de tiempo: Baseline to 4 weeks
|
Change in mean bilateral isometric hip extension strength measured using an EasyForce dynamometer, expressed in kg. |
Baseline to 4 weeks
|
|
Change in Timed Up and Go Test Time
Periodo de tiempo: Baseline to 4 weeks
|
Change in time required to complete the Timed Up and Go test, expressed in seconds. |
Baseline to 4 weeks
|
|
Change in Step Length
Periodo de tiempo: Baseline to 4 weeks
|
Change in mean bilateral step length measured using the Zebris FDM-THQ instrumented treadmill, expressed in cm. |
Baseline to 4 weeks
|
|
Change in COP Sway Area
Periodo de tiempo: Baseline to 4 weeks
|
Change in center-of-pressure sway area measured during 30-second quiet standing using a dual-plate posturographic platform, expressed in mm². |
Baseline to 4 weeks
|
|
Change in Body Mass
Periodo de tiempo: Baseline to 4 weeks
|
Change in body mass measured using bioelectrical impedance analysis, expressed in kg. |
Baseline to 4 weeks
|
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Change in Estimated Muscle Mass
Periodo de tiempo: Baseline to 4 weeks
|
Change in estimated muscle mass measured using bioelectrical impedance analysis, expressed in kg. |
Baseline to 4 weeks
|
|
Change in Fat Mass
Periodo de tiempo: Baseline to 4 weeks
|
Change in fat mass measured using bioelectrical impedance analysis, expressed in kg. |
Baseline to 4 weeks
|
|
Change in Bone Mass
Periodo de tiempo: Baseline to 4 weeks
|
Change in estimated bone mass measured using bioelectrical impedance analysis, expressed in kg. |
Baseline to 4 weeks
|
Colaboradores e Investigadores
Patrocinador
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
Palabras clave
Otros números de identificación del estudio
- AWF-SENIORS-44024
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
De-identified individual participant data underlying the reported results are available from the corresponding author upon reasonable request.
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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