An interventional study of Exercise training in HIV-1-infection and Aging, sponsored by University of Maryland, Baltimore. Completed. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2022-12-06.
Sponsored by University of Maryland, Baltimore · Not applicable, Interventional, and Other
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.
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:
Feasibility Objectives met:
Exclusion Criteria:
In the moderate-intensity aerobic exercise group, participants performed a self-paced 1-mile walk (3-5 METs) on an indoor track in the same exercise center as the high-intensity exercise group. Initial sessions lasted 20-30 minutes and were increased weekly to 45 minutes in parallel to the duration of the high-intensity exercise group.
Behavioral: Exercise training
In the high-intensity aerobic exercise group, exercise training was performed on a motorized treadmill with occasional substitution with the elliptical machine as needed for joint pain. Target heart rate was based on the baseline treadmill test and was calculated as percentage of the heart rate reserve (HRR=maximal HR-resting HR). Initially, participants trained for 20-30 minutes at 50-60% of HRR. Duration and intensity was increased by 10% weekly so that within 5-7 weeks the aerobic exercise sessions lasted 30-45 minutes at 70-85% of HRR and at the end of the 16 weeks lasted 40-45 minutes at 75-90% of HRR.
Behavioral: Exercise training
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.
Change from baseline Cardiorespiratory Fitness at 16 weeks
Cardiorespiratory Fitness measured by VO2peak
Time frame: 16-weeks
Change from baseline Six-minute walk distance at 16 weeks
Distance walked at normal pace in 6 minutes
Time frame: 16-weeks
Change from baseline body composition at 16 weeks
body composition measured as total and regional lean tissue and fat mass (DXA)
Time frame: 16-weeks
Change from baseline exercise endurance at 16 weeks
exercise endurance measured as time on treadmill during modified Bruce protocol
Time frame: 16-weeks
skeletal muscle oxidative function
activity of enzymes in oxidative function from muscle biopsy
Time frame: baseline
No study locations are listed for this record.
Plan to share: No — Data, which include PHI, are available from the University of Maryland School of Medicine Institutional Review Board for researchers who meet the criteria for access to confidential data.
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Maryland, Baltimore