Fitness and Longevity in Exercise

Study Overview
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Brief Summary
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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
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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.

Official Title
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Fitness and Longevity in Exercise

Conditions
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HIV-1-infection, Aging

Intervention / Treatment
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* Behavioral: Exercise training


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moderate-intensity aerobic exercise<br>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<br>* 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.<br>|
| Experimental: High-intensity aerobic exercise<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Cardiorespiratory Fitness at 16 weeks | Cardiorespiratory Fitness measured by VO2peak | 16-weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise training, Intervention, Aerobic capacity