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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03748797
Recruitment Status : Completed
First Posted : November 21, 2018
Last Update Posted : November 23, 2018
Sponsor:
Collaborator:
The University of Hong Kong
Information provided by (Responsible Party):
Chi Hong, CHUNG, The Society for AIDS Care

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.


Condition or disease Intervention/treatment Phase
HIV/AIDS Other: Moderate intensity exercise training under supervision Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.

Masking: Single (Outcomes Assessor)
Masking Description: A research assistant who was blinded for the participants grouping was responsible for data collection.
Primary Purpose: Treatment
Official Title: Effects of Supervised Exercise Program on Physical Health and Quality of Life Among Older Adults Living With HIV in Hong Kong
Actual Study Start Date : November 1, 2017
Actual Primary Completion Date : March 31, 2018
Actual Study Completion Date : March 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exercise group
8-week moderate intensity exercise training under supervision
Other: Moderate intensity exercise training under supervision
Upper and lower limbs cycling, treadmill walking, multi-gym strengthening, stepper exercise, dumb bell and squatting exercise

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



Primary Outcome Measures :
  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 Outcome Measures :
  1. Subjective improvement [ Time Frame: Subjective change after 8 weeks compare to baseline ]
    Subjective physical improvement reported by participant (from -100% to +100%)



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03748797


Locations
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Hong Kong
The Society for AIDS Care Day Centre
Hong Kong, Hong Kong
Sponsors and Collaborators
The Society for AIDS Care
The University of Hong Kong
Investigators
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Principal Investigator: Chi Hong Chung, MSc The Society for AIDS Care
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Responsible Party: Chi Hong, CHUNG, Physiotherapist, The Society for AIDS Care
ClinicalTrials.gov Identifier: NCT03748797    
Other Study ID Numbers: supervised exercise
First Posted: November 21, 2018    Key Record Dates
Last Update Posted: November 23, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chi Hong, CHUNG, The Society for AIDS Care:
HIV, exercise, aging, physical health, quality of life