Evaluating a Community-Based Exercise Intervention With Adults Living With HIV: An Interrupted Time Series Study

Not Applicable

Completed

• Conditions: HIV
• Interventions: Other: Community-based exercise

• Registration Number: NCT02794415
• Lead Sponsor: University of Toronto

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.

Detailed Description

Investigators will use the RE-AIM Framework to evaluate the community-based exercise (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 ultimately enhance the public health 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 with HIV participate in a CBE intervention; 2) To assess the effect of a CBE intervention on disability and health outcomes and intrinsic and extrinsic factor outcomes for people living with HIV; 3) To assess engagement in CBE for adults with HIV over time (adherence, level of physical activity); and 4) To evaluate the process (strengths and challenges; feasibility; accessibility, long term sustainability) of implementing a CBE intervention within the community from the perspective of recreation providers (fitness instructors; managers) and people living with HIV.

Investigators will conduct a prospective longitudinal study using mixed methods to evaluate a CBE intervention in the community with people living with HIV. They will use an interrupted time series (ITS) design in combination with qualitative interviews to assess outcomes at baseline (pre-testing phase), during (intervention phase) and after the CBE intervention (post-testing phase) to evaluate the short- and long-term effect of CBE.

Study Timeline

• Study First Submitted: 2016-06-01
• Study First Submitted QC: 2016-06-03
• Study First Posted: 2016-06-09
• Study Start: 2016-08
• Primary Completion: 2020-03
• Study Completion: 2020-03
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-30
• Last Update Posted: 2023-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• 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.

Exclusion Criteria

• Not applicable.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Community-based exercise	Community-based exercise	-

Primary Outcome Measures

Name	Time	Method
Maximum oxygen consumption (VO2max)	Bimonthly outcome assessment throughout baseline monitoring (8 months), intervention (6 months) and follow-up (8 months) for a total of 22 months	Maximum oxygen consumption (VO2max) ml/kg/min

Trial Locations

Locations (1)

University of Toronto; 🇨🇦 Toronto, Ontario, Canada