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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| exercise | Experimental | 16-week progressive aerobic and resistance exercise training |
|
| control | No Intervention | usual care controls |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| exercise | Other | 16-week progressive aerobic and resistance exercise training |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | at baseline and at 16 weeks (before and after the intervention phase) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kris Ann K Oursler, MD | Salem VA Medical Center, Salem, VA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD | Baltimore | Maryland | 21201 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32962523 | Result | 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. | |
| 31821043 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Exercise | 16-week progressive aerobic and resistance exercise training exercise: 16-week progressive aerobic and resistance exercise training |
| FG001 | Control | usual care controls |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Exercise | 16-week progressive aerobic and resistance exercise training exercise: 16-week progressive aerobic and resistance exercise training |
| BG001 | Control | usual care controls |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | We have incomplete data on completers in the control group. | Posted | Mean | Standard Error | Liters/minute | at baseline and at 16 weeks (before and after the intervention phase) |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Exercise | 16-week progressive aerobic and resistance exercise training exercise: 16-week progressive aerobic and resistance exercise training |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Supraventricular tachycardia | Cardiac disorders | Non-systematic Assessment | reoccurrence of pre-existing Supraventricular tachycardia |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Krisann Oursler | Salem VA Medical Center | 540-982-2463 | 4981 | krisann.oursler@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 15, 2021 | Feb 18, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| at baseline and at 16 weeks (before and after the intervention phase) |
| Salem VA Medical Center, Salem, VA |
| Salem |
| Virginia |
| 24153-6404 |
| United States |
| 31762303 | Result | 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. |
| 31547668 | Result | 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. |
| 40338873 | Result | 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. |
| Lost to Follow-up |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
usual care controls
|
|
| Primary | 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). | We have incomplete data on completers in these groups. | Posted | Mean | Standard Error | percentage | at baseline and at 16 weeks (before and after the intervention phase) |
|
|
|
| Secondary | 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). | Posted | Mean | Standard Error | pg/mL | at baseline and at 16 weeks (before and after the intervention phase) |
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 1 |
| 17 |
| EG001 | Control | usual care controls | 0 | 16 | 0 | 16 | 2 | 16 |
|
| dizziness | Cardiac disorders | Non-systematic Assessment | In delayed entry exercise of control group |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | In delayed entry exercise of control group |
|
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