HIV InfectionFIT-VETNCT04103593
Functional Interval Training for Veterans Exercising Through Telehealth.
A study testing exercise training in people with HIV Infection, run by VA Office of Research and Development at 3 sites in United States.
Trial summary
Most Veterans living with HIV are 50 years of age or older and can expect to live more than 20 years longer with HIV medication. However, despite this success, Veterans living with HIV are more likely to have age-related diseases and loss of fitness and muscle that place them at increased risk for disability. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- HIV Infection
- What is being tested?
- exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 3 sitesUnited States
- Study dates
- 10 Mar 2020to 27 Sep 2024
- 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
- Veteran living with HIV and under care at VAMC
- 50 years of age and older
- Stable antiretroviral therapy (same ARV medications within 3 months)
- At least one HIV-1 PCR < 20 c/ml (viral load) within prior 6 months
Who cannot join
- History of AIDS defining illnesses (within 6 months; CDC Criteria)
- Myocardial infarction (within 3 months)
- Exertional or unstable angina (current chest pain that limits activity)
- Severe congestive heart failure (EF < 20% in last year or NYHA Classification III or IV)
- Uncontrolled hypertension (SBP >180 \&/or DBP > 110 mm Hg)
- Therapy with beta blockers or non-dihydropyridine calcium channel blocker (within 1 month)
Show all 20Show fewer
- Screening EKG with ischemia, complex arrhythmia, or high-grade block (per Minnesota Code)
- Poorly controlled DM within prior 1 month (FBS>180 mg/dl, RBS > 299 mg/dl, or HbA1C > 10)
- Receiving treatment for cancer except skin cancer (within 3 months)
- Peripheral vascular disease with claudication
- Severe arthritis limiting ambulation
- Neurologic disease limiting ambulation (requiring assist device)
- End stage liver disease (decompensated liver disease)
- Chronic renal failure (requiring dialysis)
- Severe pulmonary disease (home O2, admission for dyspnea or pneumonia within 1 month)
- Use of systemic steroids (testosterone or glucocorticoids) or growth hormone (within 6 months)
- Dementia (based on Evaluation to Consent)
- Signs or symptoms of any medical comorbidity that would preclude exercise testing or training
- Exercise on routine basis (structured aerobic exercise > 3 times per week) within 1 month
- Past medical history of COPD or emphysema AND mMRC score =4
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, 21201
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, 30033
Salem VA Medical Center, Salem, VA
Salem, Virginia, 24153-6404
About this study
Official title: Effects of 12-weeks of High-intensity Resistance Aerobic Circuit Exercise Training on Epigenetic Aging and Inflammation in Older HIV-infected Veterans
Most Veterans living with HIV are 50 years of age or older and can expect to live more than 20 years longer with HIV medication. However, despite this success, Veterans living with HIV are more likely to have age-related diseases and loss of fitness and muscle that place them at increased risk for disability. This is a major priority for the VHA, the largest provider of HIV care in the United States. The goal of this study is to test a circuit exercise program in Veterans living with HIV that is designed to slowdown the aging process. The exercise program will be widely available by Video Teleconferencing (VTEL) and does not require stationary exercise equipment, making it widely accessible. This research will help reach the goal for Veterans to preserve their quality of life and ability to function independently. Novel findings will strengthen strategies to maintain life-long fitness through a personalized exercise prescription.
Read the detailed description
The Veterans Health Administration (VHA) is the largest U.S. HIV health provider with 64% of these Veterans 50+ years of age. HIV infection in the setting of antiretroviral therapy represents a chronic disease with an advanced aging phenotype manifested as increased cardiovascular disease, sarcopenia, and frailty, primarily driven by systemic inflammation. The investigators found a 42% reduction in VO2peak in older HIV+ adults that significantly improved with high-intensity aerobic (AEX) and resistance training (RT). Yet, durable strategies for high-intensity exercise in older adults remain a challenge and limited data are available in older HIV+ adults. There is an urgent need to address these knowledge gaps in order to prevent widespread disability in HIV+ Veterans. The objective is to provide a high-intensity exercise program for older Veterans that can be widely disseminated and attenuates processes underlying aging. Epigenetic changes with increased age encapsulate the putative effects of biological aging and lifestyle factors. DNA methylation (DNAm) patterns are frequently modified in genes encoding pro-inflammatory cytokines, but can be reversed with exercise training. DNA methylation age (DNAm Age) is an epigenetic biomarker that is expressed in years and provides a concrete benchmark of advanced aging. The investigators found that HIV+ adults have DNAm Age 11 years greater than age-matched adults without HIV. Further, in adults without HIV, increased DNAm Age is associated with physical inactivity, weakness and frailty. Preliminary data in the Veterans Aging Cohort Study (VACS) show that DNAm Age correlates with the VACS Index, a measure of frailty in HIV+ adults. However, the impact of exercise training on DNAm Age has yet to be determined in any patient population. The investigators propose to adapt center-based high-intensity AEX+RT intervention in older HIV+ Veterans into a video telehealth (VTEL) delivered functional (no stationary equipment) exercise program that leverages epigenetic outcomes to demonstrate anti-aging effects of exercise. The overarching hypothesis is that VTEL high-intensity functional circuit exercise in older HIV+ Veterans will improve the advanced aging phenotype and attenuate DNAm epigenetic processes underlying aging. Experimental approach includes a 12-week VTEL exercise intervention in 80 older HIV+ Veterans who are randomized to exercise or standard of care sedentary control groups. AIM 1 will determine the effect of VTEL exercise on VO2peak, sarcopenia, and frailty as phenotypic outcomes of advanced aging in HIV. AIM 2 will investigate the effect of VTEL exercise on DNAm Age as a biomarker of advanced aging. AIM 3 will determine the effect of VTEL exercise on DNA methylation of specific genes encoding specific pro-inflammatory cytokines in leukocytes. This approach will advance an understanding of effective and feasible exercise strategies to prevent and minimize disability in patient populations with advanced aging. Findings will provide an innovative approach to functional exercise in all older adults. DNAm Age could be used as a personalized benchmark for an individual's benefit from exercise to promote sustainable behavior change. Findings will also provide epigenetic risk profiles that can be used to generate a personalized exercise prescription, an important next step in the next decade of precision medicine. The proposal leverages exercise training experience in HIV and VTEL, availability of 3,000 HIV+ Veterans at Atlanta and Baltimore VAMCs, and the VHA VTEL infrastructure. The capacity to disseminate VTEL exercise with minimal cost using existing infrastructure will facilitate large-scale dissemination and national impact. Deliverables include improved clinical outcomes and substantial cost savings from reduced hospitalization and institutionalization rates.
- Conditions
- HIV Infection
- Being tested
- exercise training
- Keywords
- exercise training, video telehealth, DNA methylation, Aging, HIV
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise trainingBehavioural
12-weeks of high-intensity functional circuit exercise that will be broadcasted from the Salem VAMC to older Veterans living with HIV in the Atlanta and Baltimore VAMCs
| Study group | Role | What they receive |
|---|---|---|
| exercise group | Experimental | High-intensity circuit exercise training will be performed 3 times weekly for 12 weeks in a group setting. Circuit training is an exercise modality consisting of a series of exercises at different stations. Exercise training will be delivered by VTEL broadcast from the Salem VAMC to participants at the Atlanta VAMC and Baltimore VAMC. Rooms will be equipped with steps, hand and ankle weights, dumbbells, chairs and bands. No stationary exercise equipment will be used in either AEX or RT. Receives: Behavioral: exercise training |
| control group | No intervention | Sedentary activity (confirmed at eligibility no more than 1 structured physical activity/week) will be continued in participants randomized to the control group. Participants have the option after 12-week intervention phase to enter "delayed" exercise training to assure that all participants can receive exercise training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline VO2peak to After 12-week Exercise Intervention
O2 consumption at peak exercise effort, VO2peak, is used as the standard measure of aerobic capacity in sedentary adults since the majority are not able to reach maximal aerobic capacity defined as a plateau in O2 consumption. VO2peak will be the average of the final 30 second values of O2 consumption at peak exercise on a treadmill using a modified Bruce protocol
Measured: baseline and 13-weeks
Secondary outcomes (1)
Change From Baseline DNA Methylation to After 12-week Exercise Intervention
Epigenetic age acceleration (EAA)
Measured: baseline and 13-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start10 Mar 2020
- Primary completion27 Sep 2024
- Study completion27 Sep 2024
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 HIV InfectionStudies 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
- Model description
- Exercise trial of 12-weeks high-intensity circuit exercise delivered by VTEL to older Veterans living with HIV that compares exercise group to standard of care sedentary control group
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Atlanta VA Medical Center, Baltimore VA Medical Center
- Responsible party
- Sponsor
- Investigators
- Kris Ann K Oursler, MD, Principal investigator, Salem VA Medical Center, Salem, VAVincent Marconi, Principal investigator, Atlanta VA Medical and Rehab Center, Decatur, GAAlice S. Ryan, PhD, Principal investigator, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04103593
- Sponsor's protocol ID
- F2790-R
- Acronym
- FIT-VET
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2019
- Last updated
- 8 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: A Limited Dataset (LDS) will be created and shared pursuant to a Data Use Agreement (DUA) appropriately limiting use of the dataset and prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset.
Publications
Ryan AS, Marconi VC, Briggs BC, Lozano AJ, Oursler KK; FITVET Project Team. Effects of High-Intensity Functional Exercise on Cardiorespiratory Fitness and Physical Function in Older Adults With HIV: A Telerehabilitation Randomized Trial. Open Forum Infect Dis. 2026 Apr 16;13(4):ofag145. doi: 10.1093/ofid/ofag145. eCollection 2026 Apr.
PubMed 42006553Oursler KK, Marconi VC, Wang Z, Xu K, Montano M, So-Armah K, Justice AC, Sun YV. Epigenetic Age Acceleration Markers Are Associated With Physiologic Frailty and All-Cause Mortality in People With Human Immunodeficiency Virus. Clin Infect Dis. 2023 Feb 8;76(3):e638-e644. doi: 10.1093/cid/ciac656.
PubMed 35970820Oursler KK, Marconi VC, Briggs BC, Sorkin JD, Ryan AS; FIT VET Project Team. Telehealth Exercise Intervention in Older Adults With HIV: Protocol of a Multisite Randomized Trial. J Assoc Nurses AIDS Care. 2022 Mar-Apr 01;33(2):168-177. doi: 10.1097/JNC.0000000000000235.
PubMed 33481463Oursler KK, Briggs BC, Lozano AJ, Harris NM, Parashar A, Ryan AS, Marconi VC; for the FIT VET Project Team. Association of chronotropic incompetence with reduced cardiorespiratory fitness in older adults with HIV. AIDS. 2024 May 1;38(6):825-833. doi: 10.1097/QAD.0000000000003840. Epub 2024 Jan 11.
PubMed 38578959Oursler KK, Briggs BC, Lozano AJ, Harris NM, Marconi VC, Ryan AS. Association of Step Count with Cardiorespiratory Fitness: Results from the Virtual 2-Minute Step Test. Arch Rehabil Res Clin Transl. 2024 Dec 9;6(4):100369. doi: 10.1016/j.arrct.2024.100369. eCollection 2024 Dec.
PubMed 39822200
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of 12-weeks of High-intensity Resistance Aerobic Circuit Exercise Training on Epigenetic Aging and Inflammation in Older HIV-infected Veterans
- ClinicalTrials.gov ID
- NCT04103593
- Acronym / sponsor ID
- FIT-VET / F2790-R
- Conditions
- HIV Infection
- Keywords
- exercise training, video telehealth, DNA methylation, Aging, HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Atlanta VA Medical Center, Baltimore VA Medical Center
- Study start
- 10 Mar 2020 (actual)
- Primary completion
- 27 Sep 2024 (actual)
- Study completion
- 27 Sep 2024 (actual)
- First posted
- 25 Sep 2019 (actual)
- Results
- Posted 7 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Most Veterans living with HIV are 50 years of age or older and can expect to live more than 20 years longer with HIV medication. However, despite this success, Veterans living with HIV are more likely to have age-related diseases and loss of fitness and muscle that place them at increased risk for disability. This is a major priority for the VHA, the largest provider of HIV care in the United States. The goal of this study is to test a circuit exercise program in Veterans living with HIV that is designed to slowdown the aging process. The exercise program will be widely available by Video Teleconferencing (VTEL) and does not require stationary exercise equipment, making it widely accessible. This research will help reach the goal for Veterans to preserve their quality of life and ability to function independently. Novel findings will strengthen strategies to maintain life-long fitness through a personalized exercise prescription.
Detailed description
The Veterans Health Administration (VHA) is the largest U.S. HIV health provider with 64% of these Veterans 50+ years of age. HIV infection in the setting of antiretroviral therapy represents a chronic disease with an advanced aging phenotype manifested as increased cardiovascular disease, sarcopenia, and frailty, primarily driven by systemic inflammation. The investigators found a 42% reduction in VO2peak in older HIV+ adults that significantly improved with high-intensity aerobic (AEX) and resistance training (RT). Yet, durable strategies for high-intensity exercise in older adults remain a challenge and limited data are available in older HIV+ adults. There is an urgent need to address these knowledge gaps in order to prevent widespread disability in HIV+ Veterans. The objective is to provide a high-intensity exercise program for older Veterans that can be widely disseminated and attenuates processes underlying aging. Epigenetic changes with increased age encapsulate the putative effects of biological aging and lifestyle factors. DNA methylation (DNAm) patterns are frequently modified in genes encoding pro-inflammatory cytokines, but can be reversed with exercise training. DNA methylation age (DNAm Age) is an epigenetic biomarker that is expressed in years and provides a concrete benchmark of advanced aging. The investigators found that HIV+ adults have DNAm Age 11 years greater than age-matched adults without HIV. Further, in adults without HIV, increased DNAm Age is associated with physical inactivity, weakness and frailty. Preliminary data in the Veterans Aging Cohort Study (VACS) show that DNAm Age correlates with the VACS Index, a measure of frailty in HIV+ adults. However, the impact of exercise training on DNAm Age has yet to be determined in any patient population. The investigators propose to adapt center-based high-intensity AEX+RT intervention in older HIV+ Veterans into a video telehealth (VTEL) delivered functional (no stationary equipment) exercise program that leverages epigenetic outcomes to demonstrate anti-aging effects of exercise. The overarching hypothesis is that VTEL high-intensity functional circuit exercise in older HIV+ Veterans will improve the advanced aging phenotype and attenuate DNAm epigenetic processes underlying aging. Experimental approach includes a 12-week VTEL exercise intervention in 80 older HIV+ Veterans who are randomized to exercise or standard of care sedentary control groups. AIM 1 will determine the effect of VTEL exercise on VO2peak, sarcopenia, and frailty as phenotypic outcomes of advanced aging in HIV. AIM 2 will investigate the effect of VTEL exercise on DNAm Age as a biomarker of advanced aging. AIM 3 will determine the effect of VTEL exercise on DNA methylation of specific genes encoding specific pro-inflammatory cytokines in leukocytes. This approach will advance an understanding of effective and feasible exercise strategies to prevent and minimize disability in patient populations with advanced aging. Findings will provide an innovative approach to functional exercise in all older adults. DNAm Age could be used as a personalized benchmark for an individual's benefit from exercise to promote sustainable behavior change. Findings will also provide epigenetic risk profiles that can be used to generate a personalized exercise prescription, an important next step in the next decade of precision medicine. The proposal leverages exercise training experience in HIV and VTEL, availability of 3,000 HIV+ Veterans at Atlanta and Baltimore VAMCs, and the VHA VTEL infrastructure. The capacity to disseminate VTEL exercise with minimal cost using existing infrastructure will facilitate large-scale dissemination and national impact. Deliverables include improved clinical outcomes and substantial cost savings from reduced hospitalization and institutionalization rates.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Exercise trial of 12-weeks high-intensity circuit exercise delivered by VTEL to older Veterans living with HIV that compares exercise group to standard of care sedentary control group
| Arm | Type | Receives |
|---|---|---|
| exercise group | Experimental | Behavioral: exercise trainingHigh-intensity circuit exercise training will be performed 3 times weekly for 12 weeks in a group setting. Circuit training is an exercise modality consisting of a series of exercises at different stations. Exercise training will be delivered by VTEL broadcast from the Salem VAMC to participants at the Atlanta VAMC and Baltimore VAMC. Rooms will be equipped with steps, hand and ankle weights, dumbbells, chairs and bands. No stationary exercise equipment will be used in either AEX or RT. |
| control group | No intervention | –Sedentary activity (confirmed at eligibility no more than 1 structured physical activity/week) will be continued in participants randomized to the control group. Participants have the option after 12-week intervention phase to enter "delayed" exercise training to assure that all participants can receive exercise training. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Veteran living with HIV and under care at VAMC
- 50 years of age and older
- Stable antiretroviral therapy (same ARV medications within 3 months)
- At least one HIV-1 PCR < 20 c/ml (viral load) within prior 6 months
Key exclusion criteria (20 listed)
- History of AIDS defining illnesses (within 6 months; CDC Criteria)
- Myocardial infarction (within 3 months)
- Exertional or unstable angina (current chest pain that limits activity)
- Severe congestive heart failure (EF < 20% in last year or NYHA Classification III or IV)
- Uncontrolled hypertension (SBP >180 \&/or DBP > 110 mm Hg)
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 |
|---|---|---|
| exercise training12-weeks of high-intensity functional circuit exercise that will be broadcasted from the Salem VAMC to older Veterans living with HIV in the Atlanta and Baltimore VAMCs | Behavioural | exercise group |
Primary outcome
Change From Baseline VO2peak to After 12-week Exercise Intervention
Time frame: baseline and 13-weeks
O2 consumption at peak exercise effort, VO2peak, is used as the standard measure of aerobic capacity in sedentary adults since the majority are not able to reach maximal aerobic capacity defined as a plateau in O2 consumption. VO2peak will be the average of the final 30 second values of O2 consumption at peak exercise on a treadmill using a modified Bruce protocol
1 secondary outcome
Change From Baseline DNA Methylation to After 12-week Exercise Intervention
Time frame: baseline and 13-weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 42006553Ryan AS, Marconi VC, Briggs BC, Lozano AJ, Oursler KK; FITVET Project Team. Effects of High-Intensity Functional Exercise on Cardiorespiratory Fitness and Physical Function in Older Adults With HIV: A Telerehabilitation Randomized Trial. Open Forum Infect Dis. 2026 Apr 16;13(4):ofag145. doi: 10.1093/ofid/ofag145. eCollection 2026 Apr.
- Results publication: PubMed 35970820Oursler KK, Marconi VC, Wang Z, Xu K, Montano M, So-Armah K, Justice AC, Sun YV. Epigenetic Age Acceleration Markers Are Associated With Physiologic Frailty and All-Cause Mortality in People With Human Immunodeficiency Virus. Clin Infect Dis. 2023 Feb 8;76(3):e638-e644. doi: 10.1093/cid/ciac656.
- Results publication: PubMed 33481463Oursler KK, Marconi VC, Briggs BC, Sorkin JD, Ryan AS; FIT VET Project Team. Telehealth Exercise Intervention in Older Adults With HIV: Protocol of a Multisite Randomized Trial. J Assoc Nurses AIDS Care. 2022 Mar-Apr 01;33(2):168-177. doi: 10.1097/JNC.0000000000000235.
- Results publication: PubMed 38578959Oursler KK, Briggs BC, Lozano AJ, Harris NM, Parashar A, Ryan AS, Marconi VC; for the FIT VET Project Team. Association of chronotropic incompetence with reduced cardiorespiratory fitness in older adults with HIV. AIDS. 2024 May 1;38(6):825-833. doi: 10.1097/QAD.0000000000003840. Epub 2024 Jan 11.
- Results publication: PubMed 39822200Oursler KK, Briggs BC, Lozano AJ, Harris NM, Marconi VC, Ryan AS. Association of Step Count with Cardiorespiratory Fitness: Results from the Virtual 2-Minute Step Test. Arch Rehabil Res Clin Transl. 2024 Dec 9;6(4):100369. doi: 10.1016/j.arrct.2024.100369. eCollection 2024 Dec.
- Individual participant dataSharing planned: No. A Limited Dataset (LDS) will be created and shared pursuant to a Data Use Agreement (DUA) appropriately limiting use of the dataset and prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset.
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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
Vincent Marconi principal investigator
Atlanta VA Medical and Rehab Center, Decatur, GA
Alice S. Ryan, PhD principal investigator
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise training in people with HIV Infection, run by VA Office of Research and Development at 3 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 4 inclusion and 20 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 8 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 3 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 7 Jan 2026). 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?
Change From Baseline VO2peak to After 12-week Exercise Intervention (time frame: baseline and 13-weeks). 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 NCT04103593, 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 8 Oct 2026.