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Effects of Supervised Exercise on Physical Health and Quality of Life Among Older HIV Adults

20 de noviembre de 2018 actualizado por: Chi Hong, CHUNG, The Society for AIDS Care

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

Terminado

Condiciones

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

Intervencionista

Inscripción (Actual)

21

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

      • Hong Kong, Hong Kong
        • The Society for AIDS Care Day Centre

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

Todos

Descripción

Inclusion Criteria:

  1. Participants with HIV age > 50, treating with antiretroviral therapy
  2. No contraindication to moderate intensity exercise
  3. Independent Outdoor walker without assistance
  4. Sedentry participants who have not received any structural / supervised exercise program in the past 1 year

Exclusion Criteria:

  1. Age <50
  2. Unstable or unfit for exercise
  3. Wheelchair user or assisted walker
  4. Already had regular exercise habit or under structural exercise program in the past 1 year

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: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Exercise group
8-week moderate intensity exercise training under supervision
Upper and lower limbs cycling, treadmill walking, multi-gym strengthening, stepper exercise, dumb bell and squatting exercise
Sin intervención: Control group
No supervised exercise training given. Participants were advised to continue their routine daily activities and self exercises if they have

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change of SF-36 scores
Periodo de tiempo: Change from Baseline SF-36 scores at 8 weeks
Short Form 36 (SF-36) questionnaire is used to assess health related quality of life
Change from Baseline SF-36 scores at 8 weeks
Change of Grip strength
Periodo de tiempo: Change from Baseline grip strength at 8 weeks
Maximum grip strength of the participant in kg
Change from Baseline grip strength at 8 weeks
Change of 30 seconds chair stand
Periodo de tiempo: Change from Baseline performance at 8 weeks
Number of times that the participant stand up and sit down within 30 seconds
Change from Baseline performance at 8 weeks
Change of 6 minutes walk test
Periodo de tiempo: Change from Baseline performance at 8 weeks
The distance (in meters) which the participant is able to walk in 6 minutes
Change from Baseline performance at 8 weeks

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Subjective improvement
Periodo de tiempo: Subjective change after 8 weeks compare to baseline
Subjective physical improvement reported by participant (from -100% to +100%)
Subjective change after 8 weeks compare to baseline

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Chi Hong Chung, MSc, The Society for AIDS Care

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 noviembre de 2017

Finalización primaria (Actual)

31 de marzo de 2018

Finalización del estudio (Actual)

31 de marzo de 2018

Fechas de registro del estudio

Enviado por primera vez

16 de noviembre de 2018

Primero enviado que cumplió con los criterios de control de calidad

19 de noviembre de 2018

Publicado por primera vez (Actual)

21 de noviembre de 2018

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

23 de noviembre de 2018

Última actualización enviada que cumplió con los criterios de control de calidad

20 de noviembre de 2018

Última verificación

1 de noviembre de 2018

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • supervised exercise

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

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. .

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