HIVSTEELNCT02101060

Strength Training and Endurance Exercise for LIFE

A study testing exercise in people with HIV, run by VA Office of Research and Development at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 50 years and older
Conditions the study is for: HIV
What is being tested?: exercise
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 33 participants
Where: 2 sitesUnited States
Study dates: 15 Sep 2014to 4 Oct 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Human immunodeficiency virus (HIV)-infected Veterans under medical care for HIV
Antiretroviral Therapy

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, 21201
Salem VA Medical Center, Salem, VA
Salem, Virginia, 24153-6404

Other trials in United States

About this study

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

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 .

Read the detailed description

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).

Conditions: HIV
Being tested: exercise
Keywords: exercise, aging, aerobic capacity, cardiac function, inflammation
Medical subject headings: Motor Activity, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

exerciseOther
16-week progressive aerobic and resistance exercise training

Study groups in NCT02101060
Study group	Role	What they receive
exercise	Experimental	16-week progressive aerobic and resistance exercise training Receives: Other: exercise
control	No intervention	usual care controls

What is being measured

The primary outcome is the main question the study is designed to answer.

Aerobic Capacity
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).
Measured: at baseline and at 16 weeks (before and after the intervention phase)
Diastolic Function
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).
Measured: at baseline and at 16 weeks (before and after the intervention phase)

Secondary outcomes (1)

Biomarkers of Systemic Inflammation
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).
Measured: at baseline and at 16 weeks (before and after the intervention phase)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Sep 20144 Oct 2019

First posted1 Apr 2014 (estimated)
Study start15 Sep 2014
Primary completion4 Oct 2019
Study completion4 Oct 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for HIVStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 33 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02101060
Sponsor's protocol ID: O0667-R
Other IDs: RX000667
Acronym: STEEL
Status last verified: Sep 2026
First submitted: 18 Mar 2014
Last updated: 7 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Briggs BC, Ryan AS, Sorkin JD, Oursler KK. Feasibility and effects of high-intensity interval training in older adults living with HIV. J Sports Sci. 2021 Feb;39(3):304-311. doi: 10.1080/02640414.2020.1818949. Epub 2020 Sep 23.
PubMed 32962523
Oursler KK, O'Boyle HM, Briggs BC, Sorkin JD, Jarmukli N, Katzel LI, Freiberg MS, Ryan AS. Association of Diastolic Dysfunction with Reduced Cardiorespiratory Fitness in Adults Living with HIV. AIDS Patient Care STDS. 2019 Dec;33(12):493-499. doi: 10.1089/apc.2019.0149.
PubMed 31821043
Oursler KK, Iranmanesh A, Jain C, Birkett KL, Briggs BC, Garner DC, Sorkin JD, Ryan AS. Short Communication: Low Muscle Mass Is Associated with Osteoporosis in Older Adults Living with HIV. AIDS Res Hum Retroviruses. 2020 Apr;36(4):300-302. doi: 10.1089/AID.2019.0207. Epub 2019 Dec 23.
PubMed 31762303
Ryan AS, Roy A, Oursler KK. Gait and Balance Biomechanics in Older Adults With and Without Human Immunodeficiency Virus. AIDS Res Hum Retroviruses. 2019 Nov/Dec;35(11-12):1089-1094. doi: 10.1089/AID.2019.0102.
PubMed 31547668
Ryan AS, Briggs BC, Lozano AJ, Iranmanesh A, Oursler KK. Randomized Clinical Trial of High Intensity Exercise in People with HIV: Effects on Muscle Composition and Inflammation. J Acquir Immune Defic Syndr. 2025 May 8:10.1097/QAI.0000000000003692. doi: 10.1097/QAI.0000000000003692. Online ahead of print.
PubMed 40338873

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Exercise Training on Inflammation and Function in HIV Infected Veterans
ClinicalTrials.gov ID: NCT02101060
Acronym / sponsor ID: STEEL / O0667-R
Conditions: HIV
Keywords: exercise, aging, aerobic capacity, cardiac function, inflammation
Study type: Interventional
Recruitment status: Completed
Enrolment: 33 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Study start: 15 Sep 2014 (actual)
Primary completion: 4 Oct 2019 (actual)
Study completion: 4 Oct 2019 (actual)
First posted: 1 Apr 2014 (estimated)
Results: Posted 11 May 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
exercise	Experimental	Other: exercise16-week progressive aerobic and resistance exercise training
control	No intervention	–usual care controls

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Human immunodeficiency virus (HIV)-infected Veterans under medical care for HIV
Antiretroviral Therapy

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
exercise16-week progressive aerobic and resistance exercise training	Other	exercise

Primary outcome

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).
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).

1 secondary outcome

Biomarkers of Systemic Inflammation
Time frame: at baseline and at 16 weeks (before and after the intervention phase)

Results and safety

Results posted to the registry on 11 May 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Exercise	17	12
Control	16	12

Primary outcome: Aerobic Capacity

Time frame: at baseline and at 16 weeks (before and after the intervention phase). Mean (Standard Error). Unit: Liters/minute

Measure	Exercise n = 12	Control n = 11
Value	0.15 (0.04)	0.02 (0.07)

Population analysed: We have incomplete data on completers in the control group.

Primary outcome: Diastolic Function

Time frame: at baseline and at 16 weeks (before and after the intervention phase). Mean (Standard Error). Unit: percentage

Measure	Exercise n = 11	Control n = 10
Value	1.8 (1.9)	0.5 (2.7)

Population analysed: We have incomplete data on completers in these groups.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Data collected from time of enrollment to completion of study. For intervention group, duration of study is approximately 30 weeks. For control group, duration of study is approximately 50 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Exercise	0 of 17 (0%)	1 of 17 (5.9%)	0 of 17
Control	0 of 16 (0%)	2 of 16 (12.5%)	0 of 16

Limitations and caveats (from the sponsor): Exclusion criteria may limit the generalizability of findings. While AIDS-related conditions are an exclusion criteria, the period is limited to the prior 6 months. In order to minimize confounding by ART medication, we require participants to be on the same regimen for at least 3 months prior to enrollment. Therefore, we have included a control group without exercise and assume that the risk of confounding from ART and other medications will be equally distributed across groups.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 32962523Briggs BC, Ryan AS, Sorkin JD, Oursler KK. Feasibility and effects of high-intensity interval training in older adults living with HIV. J Sports Sci. 2021 Feb;39(3):304-311. doi: 10.1080/02640414.2020.1818949. Epub 2020 Sep 23.
Results publication: PubMed 31821043Oursler KK, O'Boyle HM, Briggs BC, Sorkin JD, Jarmukli N, Katzel LI, Freiberg MS, Ryan AS. Association of Diastolic Dysfunction with Reduced Cardiorespiratory Fitness in Adults Living with HIV. AIDS Patient Care STDS. 2019 Dec;33(12):493-499. doi: 10.1089/apc.2019.0149.
Results publication: PubMed 31762303Oursler KK, Iranmanesh A, Jain C, Birkett KL, Briggs BC, Garner DC, Sorkin JD, Ryan AS. Short Communication: Low Muscle Mass Is Associated with Osteoporosis in Older Adults Living with HIV. AIDS Res Hum Retroviruses. 2020 Apr;36(4):300-302. doi: 10.1089/AID.2019.0207. Epub 2019 Dec 23.
Results publication: PubMed 31547668Ryan AS, Roy A, Oursler KK. Gait and Balance Biomechanics in Older Adults With and Without Human Immunodeficiency Virus. AIDS Res Hum Retroviruses. 2019 Nov/Dec;35(11-12):1089-1094. doi: 10.1089/AID.2019.0102.
Results publication: PubMed 40338873Ryan AS, Briggs BC, Lozano AJ, Iranmanesh A, Oursler KK. Randomized Clinical Trial of High Intensity Exercise in People with HIV: Effects on Muscle Composition and Inflammation. J Acquir Immune Defic Syndr. 2025 May 8:10.1097/QAI.0000000000003692. doi: 10.1097/QAI.0000000000003692. Online ahead of print.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kris Ann K Oursler, MD principal investigator

Salem VA Medical Center, Salem, VA

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing exercise in people with HIV, run by VA Office of Research and Development at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Aerobic Capacity (time frame: at baseline and at 16 weeks (before and after the intervention phase)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02101060, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.