Fitness and Longevity in Exercise

Not Applicable

Completed

• Conditions: HIV-1-infection; Aging

• Registration Number: NCT03399136
• Lead Sponsor: University of Maryland, Baltimore

Brief Summary

The study objective was to determine the safety and efficacy of aerobic exercise in older HIV-infected men in a randomized trial comparing different levels of exercise intensity.

Detailed Description

The study was a randomized trial of moderate-intensity versus high-intensity aerobic exercise (AEX) training in older HIV-infected adults. Funding was provided by K23 AG024896 (PI, Oursler) and the UMB Claude D. Pepper Older Americans Independence Center P60 AG12583 (PI, Goldberg).

The central hypothesis was that high-intensity AEX training is well-tolerated and significantly increases aerobic capacity in older HIV-infected adults.

The study met its objectives:

1. Scientific AIMS met:

1. High-intensity AEX training significantly increases aerobic capacity

2. Both moderate-intensity and high-intensity AEX training improve ambulatory function and endurance.

3. Activity of skeletal muscle oxidative enzymes is reduced, and associated with aerobic capacity.

2. Feasibility Objectives met:

1. AEX training is safe and well-tolerated in older HIV-infected adults.

2. Skeletal muscle punch biopsy is safe and well-tolerated in older HIV-infected adults.

3. Preliminary data was collected on plasma biomarkers of inflammation.

Study Timeline

• Study Start: 2007-07-19
• Primary Completion: 2010-10-29
• Study Completion: 2012-04-23
• Study First Submitted: 2018-01-04
• Study First Submitted QC: 2018-01-11
• Study First Posted: 2018-01-16
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-02
• Last Update Posted: 2022-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

• HIV+
• stable combination antiretroviral therapy (cART)

Exclusion Criteria

• AIDS defining conditions in the prior six months
• Conditions that increase the risk of exercise training per the American College of Sports Medicine (ACSM)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline Cardiorespiratory Fitness at 16 weeks	16-weeks	Cardiorespiratory Fitness measured by VO2peak

Secondary Outcome Measures

Name	Time	Method
Change from baseline body composition at 16 weeks	16-weeks	body composition measured as total and regional lean tissue and fat mass (DXA)
Change from baseline Six-minute walk distance at 16 weeks	16-weeks	Distance walked at normal pace in 6 minutes
Change from baseline exercise endurance at 16 weeks	16-weeks	exercise endurance measured as time on treadmill during modified Bruce protocol