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Completed

NCT Number: NCT03399136

Fitness and Longevity in Exercise

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.

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Key information

Conditions

HIV-1-infection Aging

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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:

  • Scientific AIMS met:
  • High-intensity AEX training significantly increases aerobic capacity
  • Both moderate-intensity and high-intensity AEX training improve ambulatory function and endurance.
  • Activity of skeletal muscle oxidative enzymes is reduced, and associated with aerobic capacity.
  • Feasibility Objectives met:
  • AEX training is safe and well-tolerated in older HIV-infected adults.
  • Skeletal muscle punch biopsy is safe and well-tolerated in older HIV-infected adults.
  • Preliminary data was collected on plasma biomarkers of inflammation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Exercise Training

Behavioral

Participants attended center-based exercise sessions three times per week at the research exercise training facility located at the Baltimore VA Medical Center. All exercise training was performed under the supervision of research exercise physiologists. Heart rate (HR) was measured continuously during each session using a Polar HR watch and chest strap allowing for assessment and maintenance of treatment fidelity. Exercise logs included details on exercise type, duration, time in target heart rate zone, blood pressure and perceived intensity during each training session.

Primary outcomes

  1. Change from baseline Cardiorespiratory Fitness at 16 weeks

    Time frame: 16-weeks

    Cardiorespiratory Fitness measured by VO2peak

Secondary outcomes

  1. Change from baseline Six-minute walk distance at 16 weeks

    Time frame: 16-weeks

    Distance walked at normal pace in 6 minutes

  2. Change from baseline body composition at 16 weeks

    Time frame: 16-weeks

    body composition measured as total and regional lean tissue and fat mass (DXA)

  3. Change from baseline exercise endurance at 16 weeks

    Time frame: 16-weeks

    exercise endurance measured as time on treadmill during modified Bruce protocol

Other outcomes

  1. skeletal muscle oxidative function

    Time frame: baseline

    activity of enzymes in oxidative function from muscle biopsy

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Registry information

Acronym: FLEX

Important dates

Study start
2007
Primary completion
2010
Study completion
2012
First posted
Jan 16, 2018
Registry last updated
Dec 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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