Clinical trial NCT03748797: Effects of Supervised Exercise on Physical Health and Quality of Life Among Older HIV Adults
Official title: Effects of Supervised Exercise Program on Physical Health and Quality of Life Among Older Adults Living With HIV in Hong Kong
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Keywords: HIV, exercise, aging, physical health, quality of life
Lead sponsor: The Society for AIDS Care
Sponsor class: OTHER
Collaborators: name: The University of Hong Kong
First posted: 2018-11-21
Enrollment: 21
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Exercise group: Performed an 8-week, 2 times/week exercise training (moderate intensity) under physiotherapist supervision.

Control group: No supervised exercise training given. Participants were advised to continue their routine daily activities and self exercises if they have.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of SF-36 scores
timeFrame: Change from Baseline SF-36 scores at 8 weeks
measure: Change of Grip strength
timeFrame: Change from Baseline grip strength at 8 weeks
measure: Change of 30 seconds chair stand
timeFrame: Change from Baseline performance at 8 weeks
measure: Change of 6 minutes walk test
timeFrame: Change from Baseline performance at 8 weeks
Secondary outcomes:
measure: Subjective improvement
timeFrame: Subjective change after 8 weeks compare to baseline
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Society for AIDS Care Day Centre
Study officials:
affiliation: The Society for AIDS Care
name: Chi Hong Chung, MSc
role: PRINCIPAL_INVESTIGATOR
References: