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Fitness and Longevity in Exercise

Fitness and Longevity in Exercise

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03399136
Acronym
FLEX
Enrollment
31
Registered
2018-01-16
Start date
2007-07-19
Completion date
2012-04-23
Last updated
2022-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging, HIV-1-infection

Keywords

Exercise training, Intervention, Aerobic capacity

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.

Interventions

BEHAVIORALExercise 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.

Sponsors

University of Maryland, Baltimore
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline Cardiorespiratory Fitness at 16 weeks16-weeksCardiorespiratory Fitness measured by VO2peak

Secondary

MeasureTime frameDescription
Change from baseline Six-minute walk distance at 16 weeks16-weeksDistance walked at normal pace in 6 minutes
Change from baseline body composition at 16 weeks16-weeksbody composition measured as total and regional lean tissue and fat mass (DXA)
Change from baseline exercise endurance at 16 weeks16-weeksexercise endurance measured as time on treadmill during modified Bruce protocol

Other

MeasureTime frameDescription
skeletal muscle oxidative functionbaselineactivity of enzymes in oxidative function from muscle biopsy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026