HIVCBENCT02794415
Evaluating a Community-Based Exercise Intervention With Adults Living With HIV: An Interrupted Time Series Study
A study testing Community-based exercise in people with HIV, run by University of Toronto at 1 site in Canada.
Trial summary
The primary aim of this research is to evaluate a community-based exercise (CBE) intervention for adults living with HIV within the community with the goal of reducing disability and enhancing health (cardiopulmonary, strength, weight and body composition, and neurocognitive outcomes) and contextual factor outcomes… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- Community-based exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2016to Mar 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (18 years and older) living with HIV in Toronto who consider themselves medically stable and safe to engage in exercise and who are willing to participate in a 22 month study involving a 14 month CBE intervention at the YMCA.
Who cannot join
- Not applicable.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Translating Exercise Into the HIV Community: Evaluating a Community-based Exercise Intervention to Improve the Health of Adults Living With HIV
The primary aim of this research is to evaluate a community-based exercise (CBE) intervention for adults living with HIV within the community with the goal of reducing disability and enhancing health (cardiopulmonary, strength, weight and body composition, and neurocognitive outcomes) and contextual factor outcomes (social support, stigma, mastery, coping) for adults living with HIV.
Read the detailed description
Investigators will use the RE-AIM Framework to evaluate the community-based exercise (CBE) intervention. The RE-AIM Framework includes criteria to evaluate the impact and translation of an intervention at both individual and organizational-levels in order to promote uptake, transferability and ultimately enhance the public health impact of health promotion interventions.
Specific study objectives are: 1) To determine the extent (proportion of sessions attended, frequency, intensity, time, type) to which adults with HIV participate in a CBE intervention; 2) To assess the effect of a CBE intervention on disability and health outcomes and intrinsic and extrinsic factor outcomes for people living with HIV; 3) To assess engagement in CBE for adults with HIV over time (adherence, level of physical activity); and 4) To evaluate the process (strengths and challenges; feasibility; accessibility, long term sustainability) of implementing a CBE intervention within the community from the perspective of recreation providers (fitness instructors; managers) and people living with HIV.
Investigators will conduct a prospective longitudinal study using mixed methods to evaluate a CBE intervention in the community with people living with HIV. They will use an interrupted time series (ITS) design in combination with qualitative interviews to assess outcomes at baseline (pre-testing phase), during (intervention phase) and after the CBE intervention (post-testing phase) to evaluate the short- and long-term effect of CBE.
- Conditions
- HIV
- Being tested
- Community-based exercise
- Keywords
- HIV, disability, rehabilitation, exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community-based exerciseOther
Intervention Phase (6 months): The HIV Community-Based Exercise (CBE) intervention is a 6-month exercise program at the Central Toronto YMCA. Participants will meet the fitness instructor to establish an individualized exercise program that will include a combination of aerobic, resistive, neuromotor and flexibility training. Participants will attend exercise sessions for ~1.5 hour, 3 times per week for 24 weeks. Sessions will be supervised weekly by a fitness instructor.
Post-Intervention Phase (8 months): At the end of the 24 week intervention, participants will be encouraged to continue to engage in unsupervised exercise 3 times per week. As per usual practice at the YMCA, a fitness instructor will be available to monitor participants monthly.
| Study group | Role | What they receive |
|---|---|---|
| Community-based exercise | Other | Not described Receives: Other: Community-based exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum oxygen consumption (VO2max)
Maximum oxygen consumption (VO2max) ml/kg/min
Measured: Bimonthly outcome assessment throughout baseline monitoring (8 months), intervention (6 months) and follow-up (8 months) for a total of 22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2016 (estimated)
- Study startAug 2016
- Primary completionMar 2020
- Study completionMar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- YMCA
- Responsible party
- Principal investigator, Kelly O'Brien, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02794415
- Sponsor's protocol ID
- REB Protocol #32910
- Acronym
- CBE
- Status last verified
- Jan 2023
- First submitted
- 1 Jun 2016
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: The data supporting the conclusions of this article are included within the article and its supplemental files. The data used and/or analysed during the current study are available from the corresponding author on reasonable request.
Publications
O'Brien KK, Bayoumi AM, Solomon P, Tang A, Murzin K, Chan Carusone S, Zobeiry M, Nayar A, Davis AM. Evaluating a community-based exercise intervention with adults living with HIV: protocol for an interrupted time series study. BMJ Open. 2016 Oct 20;6(10):e013618. doi: 10.1136/bmjopen-2016-013618.
PubMed 27798038O'Brien KK, Davis AM, Chan Carusone S, Avery L, Tang A, Solomon P, Aubry R, Zobeiry M, Ilic I, Pandovski Z, Bayoumi AM. Examining the impact of a community-based exercise intervention on cardiorespiratory fitness, cardiovascular health, strength, flexibility and physical activity among adults living with HIV: A three-phased intervention study. PLoS One. 2021 Sep 24;16(9):e0257639. doi: 10.1371/journal.pone.0257639. eCollection 2021.
PubMed 34559851Solomon P, Carusone SC, Davis AM, Aubry R, O'Brien KK. Experiences of People Living With HIV in Community Based Exercise: A Qualitative Longitudinal Study. J Int Assoc Provid AIDS Care. 2021 Jan-Dec;20:2325958221995344. doi: 10.1177/2325958221995344.
PubMed 33611978Solomon P, Chan Carusone S, Davis AM, Aubry R, O'Brien KK. A Qualitative Study of Fitness Coaches' Experiences in Community Based Exercise with People Living with HIV. J Int Assoc Provid AIDS Care. 2021 Jan-Dec;20:23259582211046762. doi: 10.1177/23259582211046762.
PubMed 34668422Turner JR, Chow J, Cheng J, Hassanali F, Sevigny H, Sperduti M, Chan Carusone S, Dagenais M, O'Brien KK. Wireless physical activity monitor use among adults living with HIV in a community-based exercise intervention study: a quantitative, longitudinal, observational study. BMJ Open. 2023 Apr 5;13(4):e068754. doi: 10.1136/bmjopen-2022-068754.
PubMed 37019491
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translating Exercise Into the HIV Community: Evaluating a Community-based Exercise Intervention to Improve the Health of Adults Living With HIV
- ClinicalTrials.gov ID
- NCT02794415
- Acronym / sponsor ID
- CBE / REB Protocol #32910
- Conditions
- HIV
- Keywords
- HIV, disability, rehabilitation, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- YMCA
- Study start
- Aug 2016 (actual)
- Primary completion
- Mar 2020 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 9 Jun 2016 (estimated)
- 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 primary aim of this research is to evaluate a community-based exercise (CBE) intervention for adults living with HIV within the community with the goal of reducing disability and enhancing health (cardiopulmonary, strength, weight and body composition, and neurocognitive outcomes) and contextual factor outcomes (social support, stigma, mastery, coping) for adults living with HIV.
Detailed description
Investigators will use the RE-AIM Framework to evaluate the community-based exercise (CBE) intervention. The RE-AIM Framework includes criteria to evaluate the impact and translation of an intervention at both individual and organizational-levels in order to promote uptake, transferability and ultimately enhance the public health impact of health promotion interventions.
Specific study objectives are: 1) To determine the extent (proportion of sessions attended, frequency, intensity, time, type) to which adults with HIV participate in a CBE intervention; 2) To assess the effect of a CBE intervention on disability and health outcomes and intrinsic and extrinsic factor outcomes for people living with HIV; 3) To assess engagement in CBE for adults with HIV over time (adherence, level of physical activity); and 4) To evaluate the process (strengths and challenges; feasibility; accessibility, long term sustainability) of implementing a CBE intervention within the community from the perspective of recreation providers (fitness instructors; managers) and people living with HIV.
Investigators will conduct a prospective longitudinal study using mixed methods to evaluate a CBE intervention in the community with people living with HIV. They will use an interrupted time series (ITS) design in combination with qualitative interviews to assess outcomes at baseline (pre-testing phase), during (intervention phase) and after the CBE intervention (post-testing phase) to evaluate the short- and long-term effect of CBE.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Community-based exercise | Other | Other: Community-based exercise |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults (18 years and older) living with HIV in Toronto who consider themselves medically stable and safe to engage in exercise and who are willing to participate in a 22 month study involving a 14 month CBE intervention at the YMCA.
Key exclusion criteria (1 listed)
- Not applicable.
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 |
|---|---|---|
| Community-based exerciseIntervention Phase (6 months): The HIV Community-Based Exercise (CBE) intervention is a 6-month exercise program at the Central Toronto YMCA. Participants will meet the fitness instructor to establish an individualized exercise program that will include a combination of aerobic, resistive, neuromotor and flexibility training. Participants will attend exercise sessions for ~1.5 hour, 3 times per week for 24 weeks. Sessions will be supervised weekly by a fitness instructor. Post-Intervention Phase (8 months): At the end of the 24 week intervention, participants will be encouraged to continue to engage in unsupervised exercise 3 times per week. As per usual practice at the YMCA, a fitness instructor will be available to monitor participants monthly. | Other | Community-based exercise |
Primary outcome
Maximum oxygen consumption (VO2max)
Time frame: Bimonthly outcome assessment throughout baseline monitoring (8 months), intervention (6 months) and follow-up (8 months) for a total of 22 months
Maximum oxygen consumption (VO2max) ml/kg/min
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 1 Feb 2023.
- Background: PubMed 27798038O'Brien KK, Bayoumi AM, Solomon P, Tang A, Murzin K, Chan Carusone S, Zobeiry M, Nayar A, Davis AM. Evaluating a community-based exercise intervention with adults living with HIV: protocol for an interrupted time series study. BMJ Open. 2016 Oct 20;6(10):e013618. doi: 10.1136/bmjopen-2016-013618.
- Background: PubMed 34559851O'Brien KK, Davis AM, Chan Carusone S, Avery L, Tang A, Solomon P, Aubry R, Zobeiry M, Ilic I, Pandovski Z, Bayoumi AM. Examining the impact of a community-based exercise intervention on cardiorespiratory fitness, cardiovascular health, strength, flexibility and physical activity among adults living with HIV: A three-phased intervention study. PLoS One. 2021 Sep 24;16(9):e0257639. doi: 10.1371/journal.pone.0257639. eCollection 2021.
- Background: PubMed 33611978Solomon P, Carusone SC, Davis AM, Aubry R, O'Brien KK. Experiences of People Living With HIV in Community Based Exercise: A Qualitative Longitudinal Study. J Int Assoc Provid AIDS Care. 2021 Jan-Dec;20:2325958221995344. doi: 10.1177/2325958221995344.
- Background: PubMed 34668422Solomon P, Chan Carusone S, Davis AM, Aubry R, O'Brien KK. A Qualitative Study of Fitness Coaches' Experiences in Community Based Exercise with People Living with HIV. J Int Assoc Provid AIDS Care. 2021 Jan-Dec;20:23259582211046762. doi: 10.1177/23259582211046762.
- Derived from this study: PubMed 37019491Turner JR, Chow J, Cheng J, Hassanali F, Sevigny H, Sperduti M, Chan Carusone S, Dagenais M, O'Brien KK. Wireless physical activity monitor use among adults living with HIV in a community-based exercise intervention study: a quantitative, longitudinal, observational study. BMJ Open. 2023 Apr 5;13(4):e068754. doi: 10.1136/bmjopen-2022-068754.
- Individual participant dataSharing planned: Yes. The data supporting the conclusions of this article are included within the article and its supplemental files. The data used and/or analysed during the current study are available from the corresponding author on reasonable request.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community-based exercise in people with HIV, run by University of Toronto at 1 site in Canada.
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 1 inclusion and 1 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 1 Feb 2023. 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 Canada. 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?
Maximum oxygen consumption (VO2max) (time frame: Bimonthly outcome assessment throughout baseline monitoring (8 months), intervention (6 months) and follow-up (8 months) for a total of 22 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02794415, which also lists 5 linked publications.
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 1 Feb 2023.