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Clinical Trials/NCT03399136
NCT03399136CompletedNot Applicable

Fitness and Longevity in Exercise

University of Maryland, Baltimore0 sites31 target enrollmentStarted: July 19, 2007Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
31
Primary Endpoint
Change from baseline Cardiorespiratory Fitness at 16 weeks

Study 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:

  2. High-intensity AEX training significantly increases aerobic capacity

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

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

  5. Feasibility Objectives met:

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Double (Care Provider, Outcomes Assessor)

Eligibility Criteria

Ages
50 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

KrisAnn Oursler

Physician

University of Maryland, Baltimore

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