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

HIV/AIDS Clinical Trial

Official title:

Effects of Supervised Exercise Program on Physical Health and Quality of Life Among Older Adults Living With HIV in Hong Kong

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03748797
• Other study ID #: supervised exercise
• Status: Completed
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: March 31, 2018

Study information

• Verified date: November 2018
• Source: The Society for AIDS Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: March 31, 2018
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV/AIDS

Intervention

Other:
• Moderate intensity exercise training under supervision
Upper and lower limbs cycling, treadmill walking, multi-gym strengthening, stepper exercise, dumb bell and squatting exercise

Locations

Country	Name	City	State
Hong Kong	The Society for AIDS Care Day Centre	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The Society for AIDS Care	The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of SF-36 scores	Short Form 36 (SF-36) questionnaire is used to assess health related quality of life	Change from Baseline SF-36 scores at 8 weeks
Primary	Change of Grip strength	Maximum grip strength of the participant in kg	Change from Baseline grip strength at 8 weeks
Primary	Change of 30 seconds chair stand	Number of times that the participant stand up and sit down within 30 seconds	Change from Baseline performance at 8 weeks
Primary	Change of 6 minutes walk test	The distance (in meters) which the participant is able to walk in 6 minutes	Change from Baseline performance at 8 weeks
Secondary	Subjective improvement	Subjective physical improvement reported by participant (from -100% to +100%)	Subjective change after 8 weeks compare to baseline