Functional Interval Training for Veterans Exercising Through Telehealth.

NCT04103593 | Completed Results DMC

• 1 other identifier: F2790-R
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

HIV Infection

Keywords

exercise training; video telehealth; DNA methylation; Aging; HIV

Outcome Measures

Primary Outcomes (1)

• 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

  baseline and 13-weeks

Secondary Outcomes (1)

• Change From Baseline DNA Methylation to After 12-week Exercise Intervention

  baseline and 13-weeks

Other Outcomes (1)

• VTEL Exercise Training Feasibility

  through study completion, an average of 1 year

Study Arms (2)

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.

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.

Interventions

exercise training BEHAVIORAL

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

exercise group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Veteran living with HIV and under care at VAMC
• 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

You may not qualify if:

• 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)
• 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)

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Atlanta VA Medical Center: collaborator
• Baltimore VA Medical Center: collaborator

Study Sites (3)

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, 30033, United States

Location

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 (4)

• Oursler 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.

  PMID: 35970820 BACKGROUND

• Oursler 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.

  PMID: 33481463 BACKGROUND

• Oursler 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.

  PMID: 38578959 RESULT

• Oursler 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.

  PMID: 39822200 RESULT

MeSH Terms

Conditions

HIV Infections

Interventions

Exercise

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Dr. Krisann Oursler
• Organization: Salem VAMC

krisann.oursler@va.gov

5409822463

Study Officials

• Kris Ann K Oursler, MD

  Salem VA Medical Center, Salem, VA

  PRINCIPAL INVESTIGATOR

• Vincent Marconi

  Atlanta VA Medical and Rehab Center, Decatur, GA

  PRINCIPAL INVESTIGATOR

• Alice S. Ryan, PhD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: September 23, 2019
• First Posted: September 25, 2019
• Study Start: March 10, 2020
• Primary Completion: September 27, 2024
• Study Completion: September 27, 2024
• Last Updated: January 7, 2026
• Results First Posted: January 7, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)