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HivNCT05006391

Tele-Coaching Community-Based Exercise (CBE) Study

A study testing Tele-Coaching (Online) Community-Based Exercise in people with Hiv, run by University of Toronto at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary aim of this research is to evaluate the implementation of an online tele-coaching community-based exercise (CBE) intervention with adults living with HIV. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hiv
What is being tested?
Tele-Coaching (Online) Community-Based Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteCanada
Study dates
17 May 2021to 30 Apr 2023
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 who consider themselves medically stable and safe to engage in exercise.
  • Access to technology (computer/tablet, Wi-Fi, web-cam).
  • Willing to take part in a 12 month study involving thrice weekly exercise.

Who cannot join

  • Not applicable.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • University of Toronto

    Toronto, Ontario, M5G 1V7

Other trials in Canada

About this study

Official title: Tele-Coaching CBE Study: Evaluating the Implementation of an Online Community-Based Exercise (CBE) Intervention Using Tele-Coaching to Enhance Physical Activity Among Adults Living With HIV

The primary aim of this research is to evaluate the implementation of an online tele-coaching community-based exercise (CBE) intervention with adults living with HIV.

Read the detailed description

Investigators will use the RE-AIM (Reach-Effectiveness-Adoption-Implementation-Maintenance) Framework to evaluate the tele-coaching 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 ultimate enhance the 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 living with HIV participate in the intervention (Reach); 2) To assess the impact of the intervention on physical activity, health, and engagement in the care cascade (Effectiveness); 3) To assess engagement in exercise for adults living with HIV over time (physical activity, adherence) (Maintenance); and 4) To evaluate the a) process (strengths, challenges, accessibility, cost, fidelity) and b) feasibility of sustainability of the implementation, from the perspective of adults living with HIV, representatives of community-based organizations (CBOs), health and fitness centres, health providers, and policy stakeholders to build capacity, products, and considerations for broader implementation (Implementation and Adoption).

Investigators will conduct a prospective longitudinal mixed methods intervention study to evaluate the implementation of an innovative online tele-coaching CBE intervention with adults living with HIV. They will use a combination of quantitative (self-reported questionnaires, fitness assessments) to assess outcomes bimonthly during the tele-coaching CBE intervention (6 months) and during a follow-up monitoring phase (6 months) to evaluate the short and long term impact of online CBE. Investigators will use a qualitative longitudinal design using interviews to assess processes and outcomes at baseline (0 months), post-intervention (6 months) and post-follow-up (12 months).

Conditions
Hiv
Being tested
Tele-Coaching (Online) Community-Based Exercise
Keywords
HIV, exercise, community-based exercise, tele-rehabilitation, tele-health, rehabilitation, disability, tele-coaching
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.

  • Tele-Coaching (Online) Community-Based ExerciseOther

    PHASE 1-Intervention Phase (6 months): Participants will engage in an individual tailored home-based exercise program involving aerobic, resistance, balance and flexibility training ~60min, 3 times per week for 24 weeks. Intervention will include: Component 1) biweekly 60 min personal online coaching with a certified trainer from the YMCA (13 sessions) who will monitor and progress exercise intensity; Component 2) weekly online group-based exercise classes ~60 min each led by a trainer at YMCA; Component 3) monthly online evidence-based self-management education sessions focused on topics related to self-management and health, and physical activity living with HIV; and Component 4) a wireless physical activity monitor (WPAM) to self-monitor steps, distance, calories burned, and active minutes.

    PHASE 2: Post-Intervention (6 months): Participants will be encouraged to continue with unsupervised home / outdoor-based exercise 3 times per week and to continue using their WPAM throughout.

Study groups in NCT05006391
Study groupRoleWhat they receive
Tele-Coaching (Online) Community-Based ExerciseExperimentalThis study involves two phases: a six month online Community-Based Exercise Intervention (Phase 1), followed by a six month Follow-Up Monitoring Phase (Phase 2).
Receives: Other: Tele-Coaching (Online) Community-Based Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Physical Activity

    Change in trend (slope) in self-reported physical activity during the intervention phase (6 months) and the follow-up phase (6 months) as measured by i) whether they achieved the weekly recommended Canadian Physical Activity Guidelines, and ii) the number of days in the past week engaged in ≥30 min of moderate to vigorous physical activity (single item physical activity questionnaire).

    Measured: Weekly outcome assessment throughout the intervention phase (6 months) and follow-up monitoring phase (6 months) for a total of 12 months (48 weeks).

Secondary outcomes (4)

  1. Disability

    Change in trend (slope) in disability as during the intervention phase (6 months) and the follow-up phase (6 months) as measured by the Short Form HIV Disability Questionnaire (SF-HDQ).

    Measured: Bimonthly outcome assessment throughout the intervention phase (6 months) and follow-up monitoring phase (6 months) for a total of 13 time points.

  2. Health

    Change in trend (slope) in disability as during the intervention phase (6 months) and the follow-up phase (6 months) as measured by the EQ-5D-5L.

    Measured: Bimonthly outcome assessment throughout the intervention phase (6 months) and follow-up monitoring phase (6 months) for a total of 13 time points.

  3. Mental Health

    Change in trend (slope) in disability as during the intervention phase (6 months) and the follow-up phase (6 months) as measured by the Patient Health Questionnaire (PHQ-8).

    Measured: Bimonthly outcome assessment throughout the intervention phase (6 months) and follow-up monitoring phase (6 months) for a total of 13 time points.

  4. Engagement in Care

    Change in trend (slope) in disability as during the intervention phase (6 months) and the follow-up phase (6 months) as measured by the HIV Index of Engagement questionnaire.

    Measured: Bimonthly outcome assessment throughout the intervention phase (6 months) and follow-up monitoring phase (6 months) for a total of 13 time points.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2021
  2. Study start17 May 2021
  3. Primary completion31 Jan 2023
  4. Study completion30 Apr 2023

Resources

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
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05006391
Sponsor's protocol ID
REB Protocol #40410
Status last verified
May 2023
First submitted
21 Jul 2021
Last updated
21 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data Availability Statement: Data are available upon reasonable request. Members of the research team will have access to an anonymized aggregated dataset for this study. An aggregated dataset for the study will be made available upon reasonable request to the corresponding author in accordance with the Research Ethics Board requirements of the University of Toronto.

Publications

  • Ibanez-Carrasco F, McDuff K, Da Silva G, Bayoumi AM, Chan Carusone S, Loutfy M, Tang A, Ahluwalia P, Avery L, O'Brien KK. Qualitative insights from an online community-based exercise intervention for persons living with HIV. Front Rehabil Sci. 2025 Aug 25;6:1602007. doi: 10.3389/fresc.2025.1602007. eCollection 2025.

    PubMed 40927745

  • Su TT, Chan Carusone S, McDuff K, Ibanez-Carrasco F, Tang A, Bayoumi AM, Loutfy M, Avery L, Da Silva G, Furlan A, Trent H, Ilic I, Pandovski Z, Zobeiry M, Ahluwalia P, Krizmancic K, Jiancaro T, Torres B, Solomon P, O'Brien KK. Goals in motion: exploring goal setting among adults living with HIV who participated in an online community-based exercise intervention. Front Rehabil Sci. 2025 Jul 31;6:1644139. doi: 10.3389/fresc.2025.1644139. eCollection 2025.

    PubMed 40820990

  • O'Brien KK, Ibanez-Carrasco F, Carusone SC, Bayoumi AM, Tang A, McDuff K, Jiancaro T, Da Silva G, Torres B, Loutfy MR, Islam S, Lindsay J, Price C, Zobeiry M, Pandovski Z, Illic I, Ahluwalia P, Brown DA, Avery L, Solomon P. Piloting an online telecoaching community-based exercise intervention with adults living with HIV: protocol for a mixed-methods implementation science study. BMJ Open. 2023 Mar 30;13(3):e067703. doi: 10.1136/bmjopen-2022-067703.

    PubMed 36997255

Questions about this trial

What is this clinical trial studying?

A study testing Tele-Coaching (Online) 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 3 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 21 May 2025. 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?

Physical Activity (time frame: Weekly outcome assessment throughout the intervention phase (6 months) and follow-up monitoring phase (6 months) for a total of 12 months (48 weeks).). 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 NCT05006391, which also lists 3 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 21 May 2025.

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