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NCT Number: NCT03748797

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Moderate intensity exercise training under supervision

Other

Upper and lower limbs cycling, treadmill walking, multi-gym strengthening, stepper exercise, dumb bell and squatting exercise

Primary outcomes

  1. Change of SF-36 scores

    Time frame: Change from Baseline SF-36 scores at 8 weeks

    Short Form 36 (SF-36) questionnaire is used to assess health related quality of life

  2. Change of Grip strength

    Time frame: Change from Baseline grip strength at 8 weeks

    Maximum grip strength of the participant in kg

  3. Change of 30 seconds chair stand

    Time frame: Change from Baseline performance at 8 weeks

    Number of times that the participant stand up and sit down within 30 seconds

  4. Change of 6 minutes walk test

    Time frame: Change from Baseline performance at 8 weeks

    The distance (in meters) which the participant is able to walk in 6 minutes

Secondary outcomes

  1. Subjective improvement

    Time frame: Subjective change after 8 weeks compare to baseline

    Subjective physical improvement reported by participant (from -100% to +100%)

Sponsors and collaborators

Lead sponsor

The Society for AIDS Care

Other

Collaborators

  • The University of Hong Kong

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 21, 2018
Registry last updated
Nov 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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