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Completed

NCT Number: NCT02101060

Strength Training and Endurance Exercise for LIFE

Research is needed to determine safe and effective exercise rehabilitation programs to prevent and improve physical disability in older adults living with HIV. This problem is of great importance to the VA. The majority of the 25 thousand HIV-infected veterans are over 50 years of age (64%). The combined effect of aging and inflammation increase the risk for physical disability in older HIV-infected veterans. This translational exercise training trial will examine the cardiac and skeletal muscle effects of combined aerobic exercise and resistance training to attenuate the functional declines of aging with HIV by reducing the deleterious consequences of chronic inflammation. Findings will guide future rehabilitation research on cardiac remodeling and inflammation of skeletal muscle. The proposed research will advance the goal to develop effective rehabilitation strategies that improve the health of older HIV-infected veterans.

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Key information

Conditions

HIV Behavior Inflammation Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD, Baltimore, Maryland, United States

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About this study

The objective of this study is to determine the effect of exercise training on the central (cardiovascular) and peripheral (muscular) impairments underlying poor physical function by comparing older HIV-infected veterans randomized to combine aerobic and resistance exercise training versus usual care. The study hypothesis is that a progressive aerobic and resistance rehabilitation program will increase aerobic capacity and muscle strength, which will be mediated by improved diastolic function, increased muscle mass, and decreased systemic inflammation. To test this hypothesis, investigators will conduct a randomized 16-week trial of progressive aerobic and resistance training versus usual care control in 40 sedentary older (50+ years) HIV-infected veterans. The study will determine the effects of exercise training on aerobic capacity and diastolic function, and their relationship to changes in biomarkers of systemic inflammation and cardiac fibrosis (AIM 1). The study will also determine the effect of exercise training on strength and muscle mass, and their relationship to changes in biomarkers of systemic inflammation (AIM 2).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • HIV-infected veterans adult 50 years of age and older under medical care for HIV
  • Antiretroviral Therapy

Exclusion criteria

  • Patients with comorbid conditions that could have a potential impact on their ability to perform exercise testing and training will be excluded according to the American College of Sports Medicine
  • Only sedentary adults will be eligible. Individuals that participate in regular structured aerobic exercise or resistance training in the prior 6-months will be excluded

Treatment and study plan

Exercise

Other

16-week progressive aerobic and resistance exercise training

Primary outcomes

  1. Aerobic Capacity

    Time frame: at baseline and at 16 weeks (before and after the intervention phase)

    VO2 peak will be used as the primary measure of aerobic capacity. Subjects will be asked to exercise to voluntary exhaustion during a treadmill test using a modified Bruce protocol.

    In this Outcome, a mean difference between baseline to 16 weeks is reported (value at 16 weeks minus value at baseline).

  2. Diastolic Function

    Time frame: at baseline and at 16 weeks (before and after the intervention phase)

    Exercise stress two-dimensional transthoracic echocardiography with tissue Doppler imaging (stress-echo) will be used to collect data on diastolic function. Reporting on ejection fraction.

    In this Outcome, a mean difference between baseline to 16 weeks is reported (value at 16 weeks minus value at baseline).

Secondary outcomes

  1. Biomarkers of Systemic Inflammation

    Time frame: at baseline and at 16 weeks (before and after the intervention phase)

    Changes in plasma levels of biomarkers of chronic inflammation will be calculated pre/post intervention, and will be tested for association with changes in primary outcomes as well as between group differences. Presenting IL-18 values (log converted for analysis).

    In this Outcome, a mean difference between baseline to 16 weeks is reported (value at 16 weeks minus value at baseline).

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Effect of Exercise Training on Inflammation and Function in HIV Infected Veterans

Acronym: STEEL

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Apr 1, 2014
Registry last updated
Apr 22, 2026

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

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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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