HIV/AIDSNCT03748797
Effects of Supervised Exercise on Physical Health and Quality of Life Among Older HIV Adults
A study testing Moderate intensity exercise training under supervision in people with HIV/AIDS, run by The Society for AIDS Care at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- Moderate intensity exercise training under supervision
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Nov 2017to 31 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Supervised Exercise Program on Physical Health and Quality of Life Among Older Adults Living With HIV in Hong Kong
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.
Read more
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.
Read the 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.
- Conditions
- HIV/AIDS
- Being tested
- Moderate intensity exercise training under supervision
- Keywords
- HIV, exercise, aging, physical health, quality of life
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate intensity exercise training under supervisionOther
Upper and lower limbs cycling, treadmill walking, multi-gym strengthening, stepper exercise, dumb bell and squatting exercise
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | 8-week moderate intensity exercise training under supervision Receives: Other: Moderate intensity exercise training under supervision |
| Control group | No intervention | No supervised exercise training given. Participants were advised to continue their routine daily activities and self exercises if they have |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of SF-36 scores
Short Form 36 (SF-36) questionnaire is used to assess health related quality of life
Measured: Change from Baseline SF-36 scores at 8 weeks
Change of Grip strength
Maximum grip strength of the participant in kg
Measured: Change from Baseline grip strength at 8 weeks
Change of 30 seconds chair stand
Number of times that the participant stand up and sit down within 30 seconds
Measured: Change from Baseline performance at 8 weeks
Change of 6 minutes walk test
The distance (in meters) which the participant is able to walk in 6 minutes
Measured: Change from Baseline performance at 8 weeks
Secondary outcomes (1)
Subjective improvement
Subjective physical improvement reported by participant (from -100% to +100%)
Measured: Subjective change after 8 weeks compare to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2018
- Study start1 Nov 2017
- Primary completion31 Mar 2018
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Society for AIDS Care
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Hong Kong
- Responsible party
- Principal investigator, Chi Hong, CHUNG, The Society for AIDS Care
- Investigators
- Chi Hong Chung, MSc, Principal investigator, The Society for AIDS Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03748797
- Sponsor's protocol ID
- supervised exercise
- Status last verified
- Nov 2018
- First submitted
- 16 Nov 2018
- Last updated
- 23 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Supervised Exercise Program on Physical Health and Quality of Life Among Older Adults Living With HIV in Hong Kong
- ClinicalTrials.gov ID
- NCT03748797
- Acronym / sponsor ID
- supervised exercise
- Conditions
- HIV/AIDS
- Keywords
- HIV, exercise, aging, physical health, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- The Society for AIDS CareUniversity, hospital or other
- Collaborators
- The University of Hong Kong
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 21 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Other: Moderate intensity exercise training under supervision8-week moderate intensity exercise training under supervision |
| Control group | No intervention | –No supervised exercise training given. Participants were advised to continue their routine daily activities and self exercises if they have |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderate intensity exercise training under supervisionUpper and lower limbs cycling, treadmill walking, multi-gym strengthening, stepper exercise, dumb bell and squatting exercise | Other | Exercise group |
Primary outcome
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
Change of Grip strength
Time frame: Change from Baseline grip strength at 8 weeks
Maximum grip strength of the participant in kg
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
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
1 secondary outcome
Subjective improvement
Time frame: Subjective change after 8 weeks compare to baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chi Hong Chung, MSc principal investigator
The Society for AIDS Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate intensity exercise training under supervision in people with HIV/AIDS, run by The Society for AIDS Care at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of SF-36 scores (time frame: Change from Baseline SF-36 scores at 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2018.