Clinical trial NCT07018466: Tele-Exercise for MERP
Official title: Tele-Exercise in Veterans With Military Exposure
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Burn Pit Exposure
Keywords: Exercise
Cardiopulmonary
Military Exposure
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2025-06-12
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Tele-exercise or standard of care control
Primary purpose: TREATMENT

Brief summary: During Operations Desert Shield and Desert Storm, Veterans in combat were exposed to a variety of airborne hazards, including oil well fire smoke, emissions from burn pits, and other substances associated with negative health outcomes, including cardiovascular and pulmonary disease and cancer. More than 40% of Veterans enrolled in the VA's Airborne Hazards and Open Burn Pit Registry (AHOBPR) report functional limitations, such as difficulty running short distances. Veterans with burn pit exposures will benefit from physical activity interventions designed to improve functional ability and overall quality of life. Veterans with significant exposure to burn pits during their overseas military service will have a detailed documentation of their limitations and participate in either a 12-week coach-led tele-exercise intervention or standard of care. This project is designed to improve functional mobility and could be implemented for Veterans with burn pit exposure.

Detailed description: The most ubiquitous air born hazards resulting from recent conflicts is likely emissions from burn pits used for slow disposal of a variety of wastes, including plastics, petroleum products, metal, rubber, medical waste, and human waste. Burn pits have been used as a waste disposal practice by the United States military for several decades but were more prominent and widespread in the recent conflicts in Iraq and Afghanistan. The burning of these wastes produces toxins that have been demonstrated to produce toxicity in animal and human models and to increase the risk of cardiopulmonary disease in large, population-based studies of Veterans. These include small particulate matter (PM2,5), airborne metal particles, volatile organic compounds (VOCs), and specific byproducts of burnt petroleum products, including polycyclic aromatic hydrocarbons (PAHs).

The long-term health effects of exposure to these toxins are incompletely understood, and the subject of intense research. Increased incidence of cardiopulmonary disease is a major concern in exposed Veterans, with an increased risk of systemic hypertension, COPD, and asthma, all having been recently reported based on a large analysis of Veteran records. Dyspnea is a core symptom linking the pleotropic health effects associated with airborne hazards exposure. A recent study of nearly 2,000 Veterans demonstrated associations between dyspnea and burn pit exposure and exposure to military dusts, gases, and fumes, as well as associations between burn pit exposure and chronic bronchitis.

Among participants in the large-scale Millennium Cohort Study, Veterans who had been deployed reported shortness of breath more frequently than those who were not deployed. As a result, a federally chartered multisite program, the Post-Deployment Cardiopulmonary Evaluation Network (PDCEN), was created specifically to evaluate the causes of underlying exercise intolerance and dyspnea in this group. While this program self-selects for deployed Veterans with symptoms, the magnitude of exercise intolerance in this group is marked.

The investigators hypothesize that Veterans within the VA's Airborne Hazards and Open Burn Pit Registry (AHOBPR) have poor physical function and mobility, and high levels of dyspnea and fatigue. The investigator's global hypothesis is that exercise rehabilitation will improve functional mobility and reduce dyspnea and fatigue in Veterans with military burn pit exposure.

Eligibility criteria: Inclusion Criteria:

* Veteran
* Age \> or equal to 40 years
* Self-reported exposure to burn pits and/or burn pit smoke during overseas military deployment (at least 6 hours per day during one or more deployments of at least three months)
* ability to interact with study staff using video conferencing technology
* ability to provide written informed consent

Exclusion Criteria:

* Musculoskeletal or medical conditions which preclude participation in a tele-exercise program
* Active severe mental health or psychiatric issues, including suicidality
* Severe pulmonary disease (chronic supplemental oxygen), or lobectomy or greater resection
* Myocardial infarction (within 3 months), or exertional or unstable angina
* Uncontrolled systemic hypertension, defined as resting systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 110 at time of most recent evaluation at time of recruitment
* Active systemic treatment for cancer
* Acute care hospitalization within the last 90 days
* End-stage liver or renal disease
* Any other medical or psychiatric condition that would preclude safe participation in tele-exercise, according to the judgment of the investigators

Primary outcomes:
measure: Change in VO2peak
timeFrame: Baseline and after 12 weeks intervention or control
measure: Change in 6-minute walk test
timeFrame: Baseline and after 12-weeks intervention or control
Secondary outcomes:
measure: Change in 2-minute step test
timeFrame: Baseline and after 12-weeks intervention or control
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
state: Maryland
Study officials:
affiliation: Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
name: Alice S. Ryan, PhD
role: PRINCIPAL_INVESTIGATOR
References: