Last reviewed · How we verify

NCT04103593: FIT-VET

Functional Interval Training for Veterans Exercising Through Telehealth.

Completed NA Results posted Last updated 7 January 2026
What this trial tests

NA trial testing exercise training in HIV Infection in 89 participants. Completed in 27 September 2024.

Timeline
10 March 2020
Primary endpoint
27 September 2024
27 September 2024

Quick facts

Lead sponsorVA Office of Research and Development
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposeother
Enrollment89
Start date10 March 2020
Primary completion27 September 2024
Estimated completion27 September 2024
Sites3 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

VA Office of Research and Development — full company profile →

Who can join

50 and older, any sex, with HIV Infection. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline VO2peak to After 12-week Exercise Intervention Primary · 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

Baseline
GroupValue95% CI
Exercise Group1.99± 0.46
Control Group2.05± 0.57
12 Week Follow Up
GroupValue95% CI
Exercise Group2.07± 0.53
Control Group2.07± 0.47
Change
GroupValue95% CI
Exercise Group0.09± 0.23
Control Group0.00± 0.29

Adverse events — posted to ClinicalTrials.gov

Time frame: From consent to follow up testing (up to 1.5 years or as needed). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Exercise Group
Serious: 1/45 (2%)
Deaths: 0/45
Control Group
Serious: 2/44 (5%)
Deaths: 1/44

Serious adverse events (3 terms)

ReactionSystemExercise GroupControl Group
HospitalizationGastrointestinal disorders
HospitalizationRespiratory, thoracic and mediastinal disorders
HospitalizationMetabolism and nutrition disorders
Other adverse events (21 terms — click to expand)

ReactionSystemExercise GroupControl Group
Cold/flu symptomsInfections and infestations
Upset stomach/vomiting/diarrheaGastrointestinal disorders
Irregular heart rateCardiac disorders
Dizziness/low blood sugar related to diabetesMetabolism and nutrition disorders
Back painMusculoskeletal and connective tissue disorders
Injury from a fallMusculoskeletal and connective tissue disorders
DizzinessCardiac disorders
Knee pain from arthritisMusculoskeletal and connective tissue disorders
Chest painCardiac disorders
COVID exposureInfections and infestations
Hip and leg painMusculoskeletal and connective tissue disorders
Hypertensive episodeCardiac disorders
Abdominal painGastrointestinal disorders
Arm weaknessNervous system disorders
BlisterSkin and subcutaneous tissue disorders
VertigoEar and labyrinth disorders
Upper respiratory infectionInfections and infestations
Oral surgerySurgical and medical procedures
Wrist painMusculoskeletal and connective tissue disorders
Injury from car crashMusculoskeletal and connective tissue disorders
Muscle crampMusculoskeletal and connective tissue disorders

Most-reported serious reactions: Hospitalization, Hospitalization, Hospitalization.

Data from ClinicalTrials.gov NCT04103593 adverse events section.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Telehealth Exercise Intervention in Older Adults With HIV: Protocol of a Multisite Randomized Trial.
    Oursler KK, Marconi VC, Briggs BC, Sorkin JD, et al · · 2022 · cited 11× · PMID 33481463 · DOI 10.1097/jnc.0000000000000235
  2. Association of chronotropic incompetence with reduced cardiorespiratory fitness in older adults with HIV.
    Oursler KK, Briggs BC, Lozano AJ, Harris NM, et al · · 2024 · cited 2× · PMID 38578959 · DOI 10.1097/qad.0000000000003840
  3. Association of Step Count with Cardiorespiratory Fitness: Results from the Virtual 2-Minute Step Test.
    Oursler KK, Briggs BC, Lozano AJ, Harris NM, et al · · 2024 · PMID 39822200 · DOI 10.1016/j.arrct.2024.100369

Verify or expand the search:

Other trials of exercise training

Trials testing the same drug.

Other recruiting trials for HIV Infection

Currently open trials in the same condition.

Other VA Office of Research and Development trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04103593.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing