- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07598123
Effects of Multi-component Exercise on Physical Performance and Sleep Quality in Older Adults
Effects of a Multi-component Group Exercise Program on Physical Performance and Sleep Quality in Older Adults: A Quasi-Experimental Study
This quasi-experimental study evaluated the effects of an 8-week multi-component group exercise program on physical performance and sleep quality among community-dwelling older adults in Taiwan. Participants were recruited from four community care sites in central Taiwan. The intervention group participated in a structured exercise program consisting of aerobic, resistance, balance, and flexibility training conducted at a university-affiliated senior fitness club, while the control group maintained their usual community activities.
Primary outcomes included physical performance and sleep quality. Physical performance was assessed using gait speed, chair stand, arm curl, grip strength, balance, and walking tests. Sleep quality was measured using the Chinese version of the Pittsburgh Sleep Quality Index (CPSQI). Heart rate recovery was evaluated as a secondary outcome. Pre- and post-intervention assessments were conducted to determine the effectiveness of the intervention.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Population ageing increases the importance of interventions that promote healthy ageing and prevent functional decline. Exercise interventions have demonstrated benefits for mobility, muscular strength, balance, cardiovascular health, and quality of life in older adults. However, evidence regarding structured multi-component exercise programs integrated with senior-friendly smart fitness equipment and their effects on sleep quality remains limited.
This study aimed to evaluate the effects of an 8-week multi-component group exercise program on physical performance and sleep quality in community-dwelling older adults in Taiwan. The intervention was designed according to the American College of Sports Medicine (ACSM) recommendations for older adults and incorporated aerobic exercise, resistance training, balance training, and flexibility exercises.
Participants in the intervention group attended weekly 100-minute exercise sessions consisting of warm-up activities, whole-body vibration training, treadmill or stationary bicycle aerobic exercise, hydraulic-based isokinetic resistance training, and cool-down exercises. Exercise intensity was monitored using heart rate and session rating of perceived exertion (sRPE). The control group maintained their regular community activities without structured exercise intervention.
The primary outcomes were changes in physical performance and sleep quality. Secondary outcomes included heart rate recovery as an indicator of cardiovascular fitness. This study provides evidence regarding the feasibility and effectiveness of community-based multi-component exercise programs for older adults.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Taichung, Taiwán, 407224
- Tunghai University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Community-dwelling older adults aged 65 to 90 years.
- Able to communicate in Mandarin or Taiwanese.
- Able to participate in exercise activities.
- Provided written informed consent.
Exclusion Criteria:
- Contraindications to exercise, including recent myocardial infarction, acute cardiovascular events, acute infection, or renal disease symptoms.
- Use of ambulatory assistive devices.
- Regular physical activity exceeding 150 minutes per week.
- Positive responses indicating elevated exercise risk on the Physical Activity Readiness Questionnaire (PAR-Q).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- 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: an 8-week multi-component group exercise program
Participants attended weekly 100-minute supervised exercise sessions including warm-up stretching, aerobic exercise using treadmills and stationary bicycles, whole-body vibration training, resistance exercise using hydraulic isokinetic equipment, and cool-down activities.
Exercise intensity was monitored using heart rate and perceived exertion.
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Participants attended weekly 100-minute supervised exercise sessions including warm-up stretching, aerobic exercise using treadmills and stationary bicycles, whole-body vibration training, resistance exercise using hydraulic isokinetic equipment, and cool-down activities.
Exercise intensity was monitored using heart rate and perceived exertion.
Otros nombres:
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Sin intervención: Routine community activities
Control Group: Participants continued their routine community activities without participating in the structured exercise intervention.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Chair Stand Test
Periodo de tiempo: Baseline and week 8
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The Chair Stand Test assesses lower-body muscle strength by measuring the time required for participants to complete five chair stands consecutively with arms crossed over the chest.
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Baseline and week 8
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30-second Arm Curl Test
Periodo de tiempo: baseline and week 8
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The 30-second Arm Curl Test assesses upper-body muscle endurance by counting the number of arm curls completed within 30 seconds using a dumbbell weighing 2.27 kg for women and 3.63 kg for men.
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baseline and week 8
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Grip Strength Test
Periodo de tiempo: baseline and week 8
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The Grip Strength Test assesses hand muscle strength using a hand dynamometer.
Participants perform maximal grip force with the dominant hand, and the measured force is recorded in kilograms.
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baseline and week 8
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Side-by-Side Stand Test
Periodo de tiempo: baseline and week 8
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The Side-by-Side Stand Test assesses static balance by measuring the participant's ability to maintain a side-by-side standing position without assistance.
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baseline and week 8
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Tandem Stand Test
Periodo de tiempo: baseline and week 8
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The Tandem Stand Test assesses static balance by measuring the length of time participants can maintain a heel-to-toe standing position, up to a maximum of 10 seconds.
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baseline and week 8
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2.44-meter Timed Walk Test
Periodo de tiempo: baseline and week 8
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The 2.44-meter Timed Walk Test assesses mobility and dynamic balance by recording the time required for participants to stand up from a seated position, walk 2.44 meters around a cone, and return to the chair.
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baseline and week 8
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Time to Walk 4 Meters
Periodo de tiempo: Baseline and week 8
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Time required to walk 4 meters at usual pace.
Gait speed is expressed in meters per second (m/s).
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Baseline and week 8
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Sleep Quality
Periodo de tiempo: Baseline and week 8
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Sleep quality was assessed with the Chinese version of Pittsburgh Sleep Quality Index (CPSQI), a validated translation of the Pittsburgh Sleep Quality Index (PSQI).
It includes nine self-reported items scored across seven domains: subjective sleep quality, latency, duration, habitual efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction, all assessed over the past month.
Scores range from 0 to 21, with scores greater than 5 indicating poor sleep quality.
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Baseline and week 8
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Heart Rate Recovery
Periodo de tiempo: Week 1 and Week 8
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Heart rate recovery (HRR) was assessed two minutes after treadmill exercise and defined as the difference between heart rate immediately post-exercise and at two minutes recovery.
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Week 1 and Week 8
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Yi-Ling Tseng, MSN, Tunghai University
Publicaciones y enlaces útiles
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
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Nervioso
- Desordenes mentales
- Trastornos del sueño y la vigilia
- Trastornos del Sueño Intrínsecos
- Disomnias
- Comportamiento
- Trastornos de iniciación y mantenimiento del sueño
- Actividad del motor
- Actividad motora
- Movimiento
- Fenómenos fisiológicos musculoesqueléticos
- Fenómenos fisiológicos musculoesqueléticos y neuronales
- Ejercicio
Otros números de identificación del estudio
- CS1-24033
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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