Burn Pit ExposureTEMPONCT07018466
Tele-Exercise for MERP
A study testing Tele-exercise in people with Burn Pit Exposure, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Burn Pit Exposure
- What is being tested?
- Tele-exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2026to 1 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Veteran
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, 21201
Kristina Marcus, MS, (410) 605-7000, kristina.marcus@va.gov
Dillon Kuszmaul, PhD, (410) 605-7000, dillon.kuszmaul@va.gov
About this study
Official title: Tele-Exercise in Veterans With Military Exposure
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.
Read the 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.
- Conditions
- Burn Pit Exposure
- Being tested
- Tele-exercise, Standard of Care
- Keywords
- Exercise, Cardiopulmonary, Military Exposure
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-exerciseOther
Exercise training 3x/week at home. Sessions include circuit exercises of aerobic and resistive training stations which are led remotely.
Standard of CareOther
Health education discussions and lectures 3x/week led remotely.
| Study group | Role | What they receive |
|---|---|---|
| Tele-exercise | Active comparator | Exercise training 3x/week at home. Sessions include circuit exercises of aerobic and resistive training stations which are led remotely. Receives: Other: Tele-exercise |
| Standard of Care | Placebo comparator | Health education discussions and lectures 2-3x/week led remotely. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in VO2peak
physical fitness, units are ml/kg/min
Measured: Baseline and 12 weeks intervention or control
Change in 6-minute walk test
distance, units are m
Measured: Baseline and 12-weeks intervention or control
Secondary outcomes (1)
Change in 2-minute step test
physical function, units are number of times
Measured: Baseline and 12-weeks intervention or control
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start17 Aug 2026 (estimated)
- Primary completion1 Dec 2029 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burn Pit ExposureStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Tele-exercise or standard of care control
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Alice S. Ryan, PhD, Principal investigator, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07018466
- Sponsor's protocol ID
- CARA-010-24F
- Acronym
- TEMPO
- Status last verified
- Jul 2026
- First submitted
- 4 Jun 2025
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tele-Exercise in Veterans With Military Exposure
- ClinicalTrials.gov ID
- NCT07018466
- Acronym / sponsor ID
- TEMPO / CARA-010-24F
- Conditions
- Burn Pit Exposure
- Keywords
- Exercise, Cardiopulmonary, Military Exposure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 17 Aug 2026 (estimated)
- Primary completion
- 1 Dec 2029 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 12 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Tele-exercise or standard of care control
| Arm | Type | Receives |
|---|---|---|
| Tele-exercise | Active comparator | Other: Tele-exerciseExercise training 3x/week at home. Sessions include circuit exercises of aerobic and resistive training stations which are led remotely. |
| Standard of Care | Placebo comparator | Other: Standard of CareHealth education discussions and lectures 2-3x/week led remotely. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Veteran
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tele-exerciseExercise training 3x/week at home. Sessions include circuit exercises of aerobic and resistive training stations which are led remotely. | Other | Tele-exercise |
| Standard of CareHealth education discussions and lectures 3x/week led remotely. | Other | Standard of Care |
Primary outcome
Change in VO2peak
Time frame: Baseline and 12 weeks intervention or control
physical fitness, units are ml/kg/min
Change in 6-minute walk test
Time frame: Baseline and 12-weeks intervention or control
distance, units are m
1 secondary outcome
Change in 2-minute step test
Time frame: Baseline and 12-weeks intervention or control
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Burn Pit Exposure
Enrolling by invitation
Personalizing Veterans' Lung Cancer Screening and Diagnosis
Lung Cancer Screening, Military Service-related Environmental and Occupational Exposures
Recruiting
Burn Pit Exposure in Veterans: A Cancer Screening Pilot Study at the Inova Saville Cancer Screening & Prevention Center
Cancer
Not yet recruitingPhase 2
Use of Bile Acid Binding Resins to Decrease PFAS Levels Via Colesevalem in Veterans Study
PFAS, Environmental Exposures
Not yet recruitingObservational study
Project PHOENIX: Molecular Signatures of Burn Pit Exposure
Burn Pit Exposure, Airborne Hazard Exposure
RecruitingObservational study
DNA Methylation Markers in Veterans Exposed to Open Burn Pits
Open Burn Pit Exposure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alice S. Ryan, PhD principal investigator
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele-exercise in people with Burn Pit Exposure, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alice S Ryan, PhD ((410) 605-7851, Alice.Ryan@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in VO2peak (time frame: Baseline and 12 weeks intervention or control). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.