NCT02794415

Brief 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 (social support, stigma, mastery, coping) for adults living with HIV.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P25-P50 for not_applicable hiv

Timeline
Completed

Started Aug 2016

Typical duration for not_applicable hiv

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

First Submitted

Initial submission to the registry

June 1, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 9, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

February 1, 2023

Status Verified

January 1, 2023

Enrollment Period

3.6 years

First QC Date

June 1, 2016

Last Update Submit

January 30, 2023

Conditions

Keywords

HIVdisabilityrehabilitationexercise

Outcome Measures

Primary Outcomes (1)

  • Maximum oxygen consumption (VO2max)

    Maximum oxygen consumption (VO2max) ml/kg/min

    Bimonthly outcome assessment throughout baseline monitoring (8 months), intervention (6 months) and follow-up (8 months) for a total of 22 months

Study Arms (1)

Community-based exercise

OTHER
Other: Community-based exercise

Interventions

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.

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 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.

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 (5)

  • 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.

    PMID: 27798038BACKGROUND
  • O'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.

    PMID: 34559851BACKGROUND
  • Solomon 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.

    PMID: 33611978BACKGROUND
  • Solomon 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.

    PMID: 34668422BACKGROUND
  • Turner 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.

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

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

June 1, 2016

First Posted

June 9, 2016

Study Start

August 1, 2016

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

February 1, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
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.
Access Criteria
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.

Locations