NCT02101060

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at below P25 for not_applicable hiv

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable hiv

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 1, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

September 15, 2014

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 4, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 4, 2019

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

May 11, 2021

Completed
Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

5.1 years

First QC Date

March 18, 2014

Results QC Date

February 18, 2021

Last Update Submit

April 2, 2026

Conditions

HIV

Keywords

exerciseagingaerobic capacitycardiac functioninflammation

Outcome Measures

Primary Outcomes (2)

  • 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)

Secondary Outcomes (1)

  • Biomarkers of Systemic Inflammation

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

Study Arms (2)

exercise

EXPERIMENTAL

16-week progressive aerobic and resistance exercise training

Other: exercise

control

NO INTERVENTION

usual care controls

Interventions

exerciseOTHER

16-week progressive aerobic and resistance exercise training

exercise

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Baltimore, Maryland, 21201, United States

Location

Salem VA Medical Center, Salem, VA

Salem, Virginia, 24153-6404, United States

Location

Related Publications (5)

  • 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.

    PMID: 32962523RESULT

  • 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.

    PMID: 31821043RESULT

  • 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.

    PMID: 31762303RESULT

  • 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.

    PMID: 31547668RESULT

  • 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. doi: 10.1097/QAI.0000000000003692. Online ahead of print.

    PMID: 40338873RESULT

MeSH Terms

Conditions

Motor ActivityInflammation

Interventions

Exercise

Condition Hierarchy (Ancestors)

BehaviorPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Limitations and Caveats

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.

Results Point of Contact

Title
Dr. Krisann Oursler
Organization
Salem VA Medical Center
krisann.oursler@va.gov
540-982-2463

Study Officials

  • Kris Ann K Oursler, MD

    Salem VA Medical Center, Salem, VA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2014

First Posted

April 1, 2014

Study Start

September 15, 2014

Primary Completion

October 4, 2019

Study Completion

October 4, 2019

Last Updated

April 22, 2026

Results First Posted

May 11, 2021

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(2)