- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03748797
Effects of Supervised Exercise on Physical Health and Quality of Life Among Older HIV Adults
Effects of Supervised Exercise Program on Physical Health and Quality of Life Among Older Adults Living With HIV in Hong Kong
The effects of exercise for older HIV-infected adults have not been well studied, especially in Chinese population. This study aimed to investigate the effect of supervised exercise on physical health and quality of life among older people living with HIV (PLWH) in Hong Kong.
HIV-infected adults were recruited from a community-based Non-Governmental Organization (NGO) for HIV patient services. Participants were randomized into exercise group or control group. The participants in exercise group performed an 8-week moderate intensity supervised exercise program. In the control group, participants were not given any supervised exercises. They were advised to continue their routine daily activities and self exercises.
Outcomes were measured for both groups at baseline and after 8 weeks. Primary outcomes: grip strength, 30 seconds chair stand, 6 minutes-walk test and Short Form-36 questionnaire (SF-36). Secondary outcome: Subjective improvement
At the end of the program, all participants from exercise group were interviewed individually by principle investigator to allow feedbacks.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
It is a randomized controlled trial. HIV-infected adults were recruited from a community-based Non-Governmental Organization (NGO) for HIV patient services.They were randomized into exercise group or control group by drawing lots which contained equal number of orange balls (exercise) and white balls (control)
The participants in exercise group performed an 8-week, 2 times/week supervised exercise program in the community day center of the recruiting NGO. Exercise sessions were organized in a group of 2 to 3 participants. The exercises were supervised by a registered physiotherapist to ensure exercise safety and quality. Exercise intensity was moderate. We monitored the heart rate of participants during exercise and maintained around 50% to 70% of maximum heart rate. Blood pressure and oxygen saturation were also checked for safety purposes. The mode of exercise was combined aerobic and resistance training. It involved upper and lower limbs cycling, treadmill walking, multi-gym strengthening, stepper exercise, dumb bell and squatting exercise. The duration for each exercise session was around 45 minutes. Duration and intensity of exercises were adjusted depending on the tolerance and physical capacity of each participant. In the control group, participants were not given any supervised exercises. They were advised to continue their routine daily activities and self exercises. Control group participants were allowed to join into the same training program after the research had finished.
Outcomes were measured for both groups at baseline and after 8 weeks in the same community day center. A research assistant who was blinded for the participants grouping was responsible for data collection. Physical health parameters included grip strength, 30 seconds chair stand and 6 minutes-walk test. Health related quality of life was measured by Short Form-36 questionnaire (SF-36). Subjective improvement was taken in form of Likert scale, from -100% to +100% with 10% interval in each possible response.
At the end of the program, all participants from exercise group were interviewed individually by principle investigator to allow feedbacks.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Hong Kong, Hong Kong
- The Society for AIDS Care Day Centre
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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:
- Participants with HIV age > 50, treating with antiretroviral therapy
- No contraindication to moderate intensity exercise
- Independent Outdoor walker without assistance
- Sedentry participants who have not received any structural / supervised exercise program in the past 1 year
Exclusion Criteria:
- Age <50
- Unstable or unfit for exercise
- Wheelchair user or assisted walker
- Already had regular exercise habit or under structural exercise program in the past 1 year
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Exercise group
8-week moderate intensity exercise training under supervision
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Upper and lower limbs cycling, treadmill walking, multi-gym strengthening, stepper exercise, dumb bell and squatting exercise
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Sin intervención: Control group
No supervised exercise training given.
Participants were advised to continue their routine daily activities and self exercises if they have
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change of SF-36 scores
Periodo de tiempo: Change from Baseline SF-36 scores at 8 weeks
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Short Form 36 (SF-36) questionnaire is used to assess health related quality of life
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Change from Baseline SF-36 scores at 8 weeks
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Change of Grip strength
Periodo de tiempo: Change from Baseline grip strength at 8 weeks
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Maximum grip strength of the participant in kg
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Change from Baseline grip strength at 8 weeks
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Change of 30 seconds chair stand
Periodo de tiempo: Change from Baseline performance at 8 weeks
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Number of times that the participant stand up and sit down within 30 seconds
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Change from Baseline performance at 8 weeks
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Change of 6 minutes walk test
Periodo de tiempo: Change from Baseline performance at 8 weeks
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The distance (in meters) which the participant is able to walk in 6 minutes
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Change from Baseline performance at 8 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Subjective improvement
Periodo de tiempo: Subjective change after 8 weeks compare to baseline
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Subjective physical improvement reported by participant (from -100% to +100%)
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Subjective change after 8 weeks compare to baseline
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Chi Hong Chung, MSc, The Society for AIDS Care
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
- supervised exercise
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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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