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Clinical Trials/NCT03399136
NCT03399136
Completed
Not Applicable

Fitness and Longevity in Exercise

University of Maryland, Baltimore0 sites31 target enrollmentJuly 19, 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV-1-infection
Sponsor
University of Maryland, Baltimore
Enrollment
31
Primary Endpoint
Change from baseline Cardiorespiratory Fitness at 16 weeks
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 19, 2007
End Date
April 23, 2012
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

KrisAnn Oursler

Physician

University of Maryland, Baltimore

Eligibility Criteria

Inclusion Criteria

  • 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)

Outcomes

Primary Outcomes

Change from baseline Cardiorespiratory Fitness at 16 weeks

Time Frame: 16-weeks

Cardiorespiratory Fitness measured by VO2peak

Secondary Outcomes

  • Change from baseline body composition at 16 weeks(16-weeks)
  • Change from baseline Six-minute walk distance at 16 weeks(16-weeks)
  • Change from baseline exercise endurance at 16 weeks(16-weeks)

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