NCT05006391

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at below P25 for not_applicable hiv

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 17, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2021

Completed
26 days until next milestone

First Posted

Study publicly available on registry

August 16, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

May 21, 2025

Status Verified

May 1, 2023

Enrollment Period

1.7 years

First QC Date

July 21, 2021

Last Update Submit

May 15, 2025

Conditions

Keywords

HIVexercisecommunity-based exercisetele-rehabilitationtele-healthrehabilitationdisabilitytele-coaching

Outcome Measures

Primary Outcomes (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).

    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)

  • Disability

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

  • Health

    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

    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

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

Other Outcomes (2)

  • Extrinsic Contextual Factor - HIV Stigma

    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

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

Study Arms (1)

Tele-Coaching (Online) Community-Based Exercise

EXPERIMENTAL

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

Interventions

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.

Tele-Coaching (Online) Community-Based Exercise

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Not applicable.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Toronto

Toronto, Ontario, M5G 1V7, Canada

Location

Related Publications (3)

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeMotor Activity

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 21, 2021

First Posted

August 16, 2021

Study Start

May 17, 2021

Primary Completion

January 31, 2023

Study Completion

April 30, 2023

Last Updated

May 21, 2025

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
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.
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.

Locations