Tele-Coaching Community-Based Exercise (CBE) Study

May 15, 2025 updated by: Kelly O'Brien, University of Toronto

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and 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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
33

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Disability
Time Frame: Bimonthly outcome assessment throughout the intervention phase (6 months) and follow-up monitoring phase (6 months) for a total of 13 time points.
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
Time Frame: Bimonthly outcome assessment throughout the intervention phase (6 months) and follow-up monitoring phase (6 months) for a total of 13 time points.
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
Time Frame: Bimonthly outcome assessment throughout the intervention phase (6 months) and follow-up monitoring phase (6 months) for a total of 13 time points.
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
Time Frame: Bimonthly outcome assessment throughout the intervention phase (6 months) and follow-up monitoring phase (6 months) for a total of 13 time points.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Extrinsic Contextual Factor - HIV Stigma
Time Frame: Bimonthly outcome assessment throughout the intervention phase (6 months) and follow-up monitoring phase (6 months) for a total of 13 time points.
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
Time Frame: Bimonthly outcome assessment throughout the intervention phase (6 months) and follow-up monitoring phase (6 months) for a total of 13 time points.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Toronto

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
YMCA
Ontario HIV Treatment Network

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 17, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 21, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 8, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 16, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 21, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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