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Clinical Trials/NCT02794415
NCT02794415
Completed
Not Applicable

Translating Exercise Into the HIV Community: Evaluating a Community-based Exercise Intervention to Improve the Health of Adults Living With HIV

University of Toronto1 site in 1 country120 target enrollmentAugust 2016
ConditionsHIV

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV
Sponsor
University of Toronto
Enrollment
120
Locations
1
Primary Endpoint
Maximum oxygen consumption (VO2max)
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2016
End Date
March 2020
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kelly O'Brien

Associate Professor

University of Toronto

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Maximum oxygen consumption (VO2max)

Time Frame: 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

Study Sites (1)

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