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

Sponsor
The Society for AIDS Care (Other)
Overall Status
Completed
CT.gov ID
NCT03748797
Collaborator
The University of Hong Kong (Other)
21
1
2
4.9
4.3

Study Details

Study Description

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
  • Other: Moderate intensity exercise training under supervision
N/A

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.

Study Design

Study Type:
Interventional
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.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 :
Nov 1, 2017
Actual Primary Completion Date :
Mar 31, 2018
Actual Study Completion Date :
Mar 31, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change of SF-36 scores [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 [Change from Baseline grip strength at 8 weeks]

    Maximum grip strength of the participant in kg

  3. Change of 30 seconds chair stand [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 [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 [Subjective change after 8 weeks compare to baseline]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 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

  • Principal Investigator: Chi Hong Chung, MSc, The Society for AIDS Care

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chi Hong, CHUNG, Physiotherapist, The Society for AIDS Care
ClinicalTrials.gov Identifier:
NCT03748797
Other Study ID Numbers:
  • supervised exercise
First Posted:
Nov 21, 2018
Last Update Posted:
Nov 23, 2018
Last Verified:
Nov 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Chi Hong, CHUNG, Physiotherapist, The Society for AIDS Care

Study Results

No Results Posted as of Nov 23, 2018