Tele-Coaching Community-Based Exercise (CBE) Study

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.

Study Overview

• Status: Completed
• Conditions: Hiv
• Intervention / Treatment: Other: Tele-Coaching (Online) Community-Based Exercise

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).

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1V7
      • University of Toronto

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Not applicable.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Tele-Coaching (Online) Community-Based Exercise; This 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).

Other: Tele-Coaching (Online) Community-Based Exercise; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Bimonthly outcome assessment throughout the intervention phase (6 months) and follow-up monitoring phase (6 months) for a total of 13 time points.
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.	Bimonthly outcome assessment throughout the intervention phase (6 months) and follow-up monitoring phase (6 months) for a total of 13 time points.
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).	Bimonthly outcome assessment throughout the intervention phase (6 months) and follow-up monitoring phase (6 months) for a total of 13 time points.
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.	Bimonthly outcome assessment throughout the intervention phase (6 months) and follow-up monitoring phase (6 months) for a total of 13 time points.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Extrinsic Contextual Factor - HIV Stigma	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 Stigma Scale.	Bimonthly outcome assessment throughout the intervention phase (6 months) and follow-up monitoring phase (6 months) for a total of 13 time points.
Intrinsic Contextual Factor - Mastery	Change in trend (slope) in disability as during the intervention phase (6 months) and the follow-up phase (6 months) as measured by the Pearlin Mastery Scale.	Bimonthly outcome assessment throughout the intervention phase (6 months) and follow-up monitoring phase (6 months) for a total of 13 time points.

Collaborators and Investigators

• Sponsor: University of Toronto
• Collaborators: YMCA; Ontario HIV Treatment Network

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2021
• Primary Completion (Actual): January 31, 2023
• Study Completion (Actual): April 30, 2023

Study Registration Dates

• First Submitted: July 21, 2021
• First Submitted That Met QC Criteria: August 8, 2021
• First Posted (Actual): August 16, 2021

Study Record Updates

• Last Update Posted (Actual): May 21, 2025
• Last Update Submitted That Met QC Criteria: May 15, 2025
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: exercise; HIV; rehabilitation; disability; community-based exercise; tele-rehabilitation; tele-health; tele-coaching
• Other Study ID Numbers: REB Protocol #40410

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data sharing may occur within 5 years from study completion as this is the timeframe outlined in the Research Ethics Board (REB) approval, after which the data will be destroyed.
• IPD Sharing Access Criteria: Data are available upon reasonable request. 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. The request should include the research objectives in which the team is requesting use of the data, details of the team / individuals requesting the data, the variables requested, and any funding to support.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No