Occupational ExposureNCT05849168
High-Intensity Interval Training to Improve Symptoms of Deployment-Related Respiratory Disease
A study testing Exercise training in people with Occupational Exposure, run by University of Colorado, Denver at 2 sites in United States.
Trial summary
Some military personnel who have been exposed to burn pit emissions, desert dust, and other airborne hazards experience new respiratory symptoms after deployment. The goal of this clinical trial is to learn about exercise in veterans with new respiratory symptoms after deployment to Southwest Asia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Occupational Exposure
- What is being tested?
- Exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Nov 2023to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Deployment of ≥30 days to Iraq, Afghanistan, Kuwait, Saudi Arabia, Bahrain, Qatar, United Arab Emirates, Kyrgyzstan, or Djibouti after September 2001
- New onset of cough, shortness of breath, chest tightness/wheezing, dyspnea on exertion or exercise intolerance which started during or after deployment
- Definite or probable distal lung disease (≥1 hyperinflation, emphysema, bronchiolitis, small airways inflammation, peribronchiolar fibrosis, or granulomatous pneumonitis on surgical lung biopsy; or ≥2 centrilobular nodularity, air trapping, mosaicism, or bronchial wall thickening on chest computed tomography [CT]), definite or probable deployment-related asthma (≥1 increase in post-bronchodilator forced expiratory volume in 1 second [FEV1] ≥12% and ≥200cc, or methacholine challenge with provocation concentration causing a 20% decline in FEV1 [PC20] ≤16 mg/mL), or unexplained dyspnea on exertion or exercise intolerance despite noninvasive testing including pulmonary function testing, methacholine challenge, transthoracic echocardiography, and/or chest computed tomography
- Current symptoms of dyspnea on exertion or exercise intolerance
- Residence <90 miles from Rocky Mountain Regional VA and ability / willingness to attend in-person HIIT sessions and research visits
- Vaccinated against Coronavirus-19 including primary series and (if eligible) ≥1 booster
Who cannot join
- Active / uncontrolled cardiovascular or pulmonary disease (e.g. hypertension with blood pressure >160/100 despite antihypertensive therapy, known hypertensive response to exercise [systolic blood pressure >220 mmHg in men / >190 mmHg in women], coronary artery disease, left ventricular ejection fraction ≤45% or heart failure with preserved ejection fraction with ongoing symptoms despite diuretic therapy, uncontrolled arrhythmia, moderate or severe valvular abnormality, diabetes with HbA1c >8.5%, asthma exacerbation requiring steroids within 4 weeks of enrollment, interstitial lung disease, untreated severe obstructive sleep apnea)
- Pre-deployment history of cardiovascular or pulmonary disease including coronary artery disease, left ventricular ejection fraction ≤45% or heart failure with preserved ejection fraction requiring diuretic therapy, arrhythmia, valvular abnormality, chronic obstructive pulmonary disease, asthma (excluding childhood asthma that did not persist into adulthood), interstitial lung disease, or pulmonary hypertension
- Body mass index <18.5 or >45
- Anemia with hemoglobin <10 g/dl
- Disorders that adversely influence exercise ability (e.g. arthritis or peripheral vascular disease)
- Current fitness program (e.g. >30 minutes at metabolic equivalents [METs] >6 3 times/week or more)
- Pregnancy or possible anticipated pregnancy during study duration
- Post-menopausal status in women
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
VA Eastern Colorado Health Care System
Aurora, Colorado, 80045
About this study
Official title: High-Intensity Interval Training (HIIT) to Improve Symptoms of Deployment-Related Respiratory Disease - A Pilot Study
Some military personnel who have been exposed to burn pit emissions, desert dust, and other airborne hazards experience new respiratory symptoms after deployment. The goal of this clinical trial is to learn about exercise in veterans with new respiratory symptoms after deployment to Southwest Asia. The main questions it aims to answer are:
- Do veterans with new respiratory symptoms after deployment have heart or lung abnormalities that contribute to difficulty exercising?
- Does high-intensity interval training (HIIT) improve fitness and symptoms?
Read more
Study participants will complete the following:
- Study Visits 1A and 1B: Exercise test (VO2max test), echocardiogram (heart ultrasound), blood tests, questionnaires
- Exercise program: 12 weeks of 3x/week supervised HIIT on upright stationary bicycle (~40 minutes each) and 3x/week home aerobic exercise (45 minutes each)
- Study Visits 2A and 2B: Exercise test (VO2max test), echocardiogram (heart ultrasound), blood tests, questionnaires
- Conditions
- Occupational Exposure
- Being tested
- Exercise training
- Keywords
- exercise tolerance, exercise therapy, airborne hazards, deployment-related respiratory disease, veterans, burn pit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingBehavioural
Participants will complete a 12-week exercise training program. The program consists of 3x/week HIIT sessions on an upright stationary bicycle (~40 minutes each) and 3x/week home aerobic sessions (any type of aerobic exercise; 45 minutes each).
| Study group | Role | What they receive |
|---|---|---|
| Veterans with respiratory symptoms | Experimental | Not described Receives: Behavioral: Exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Oxygen Consumption (VO2max)
Obtained via metabolic cart during maximal cardiopulmonary exercise testing, in ml/kg/min
Measured: Up to 1 hour
Health-related Quality of Life by Short Form 36 (SF-36) Questionnaire
Units, Range 0-100 with higher scores indicating more favorable health state
Measured: Up to 1 hour
Secondary outcomes (4)
Left Ventricular Ejection Fraction Measured by Transthoracic Echocardiogram
%
Measured: Up to 1 hour
Tricuspid Annular Plane Systolic Excursion Measured by Transthoracic Echocardiogram
mm
Measured: Up to 1 hour
Plasma Acylcarnitine 10:0 Measured by Peripheral Venous Metabolomics (Ultra-high Performance Liquid Chromatography Coupled to Mass Spectrometry)
Relative ion count
Measured: Up to 1 hour
Feasibility of Exercise Program, Reported by Participant and Measured by Responses to Questionnaire
Score, Likert scale indicating agreement with the statement "I was able to complete the scheduled high-intensity interval training sessions," 5-point range from 1 = "Strongly disagree" to 5 = "Strongly agree" with "Strongly agree" indicating greater agreement
Measured: Up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start27 Nov 2023
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Occupational ExposureStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- VA Office of Research and Development
- Responsible party
- Sponsor
- Investigators
- William Cornwell, MD, MSCS, Principal investigator, University of Colorado, DenverLindsay Forbes, MD, Principal investigator, University of Colorado, DenverSilpa Krefft, MD, Principal investigator, VA Eastern Colorado Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05849168
- Sponsor's protocol ID
- 22-2069
- Status last verified
- Jan 2026
- First submitted
- 17 Apr 2023
- Last updated
- 29 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Intensity Interval Training (HIIT) to Improve Symptoms of Deployment-Related Respiratory Disease - A Pilot Study
- ClinicalTrials.gov ID
- NCT05849168
- Acronym / sponsor ID
- 22-2069
- Conditions
- Occupational Exposure
- Keywords
- exercise tolerance, exercise therapy, airborne hazards, deployment-related respiratory disease, veterans, burn pit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- VA Office of Research and Development
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 8 May 2023 (actual)
- Results
- Posted 29 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Some military personnel who have been exposed to burn pit emissions, desert dust, and other airborne hazards experience new respiratory symptoms after deployment. The goal of this clinical trial is to learn about exercise in veterans with new respiratory symptoms after deployment to Southwest Asia. The main questions it aims to answer are:
- Do veterans with new respiratory symptoms after deployment have heart or lung abnormalities that contribute to difficulty exercising?
- Does high-intensity interval training (HIIT) improve fitness and symptoms?
Study participants will complete the following:
- Study Visits 1A and 1B: Exercise test (VO2max test), echocardiogram (heart ultrasound), blood tests, questionnaires
- Exercise program: 12 weeks of 3x/week supervised HIIT on upright stationary bicycle (~40 minutes each) and 3x/week home aerobic exercise (45 minutes each)
- Study Visits 2A and 2B: Exercise test (VO2max test), echocardiogram (heart ultrasound), blood tests, questionnaires
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Veterans with respiratory symptoms | Experimental | Behavioral: Exercise training |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Deployment of ≥30 days to Iraq, Afghanistan, Kuwait, Saudi Arabia, Bahrain, Qatar, United Arab Emirates, Kyrgyzstan, or Djibouti after September 2001
- New onset of cough, shortness of breath, chest tightness/wheezing, dyspnea on exertion or exercise intolerance which started during or after deployment
- Definite or probable distal lung disease (≥1 hyperinflation, emphysema, bronchiolitis, small airways inflammation, peribronchiolar fibrosis, or granulomatous pneumonitis on surgical lung biopsy; or ≥2 centrilobular nodularity, air trapping, mosaicism, or bronchial wall thickening on chest computed tomography [CT]), definite or probable deployment-related asthma (≥1 increase in post-bronchodilator forced expiratory volume in 1 second [FEV1] ≥12% and ≥200cc, or methacholine challenge with provocation concentration causing a 20% decline in FEV1 [PC20] ≤16 mg/mL), or unexplained dyspnea on exertion or exercise intolerance despite noninvasive testing including pulmonary function testing, methacholine challenge, transthoracic echocardiography, and/or chest computed tomography
- Current symptoms of dyspnea on exertion or exercise intolerance
- Residence <90 miles from Rocky Mountain Regional VA and ability / willingness to attend in-person HIIT sessions and research visits
Key exclusion criteria (8 listed)
- Active / uncontrolled cardiovascular or pulmonary disease (e.g. hypertension with blood pressure >160/100 despite antihypertensive therapy, known hypertensive response to exercise [systolic blood pressure >220 mmHg in men / >190 mmHg in women], coronary artery disease, left ventricular ejection fraction ≤45% or heart failure with preserved ejection fraction with ongoing symptoms despite diuretic therapy, uncontrolled arrhythmia, moderate or severe valvular abnormality, diabetes with HbA1c >8.5%, asthma exacerbation requiring steroids within 4 weeks of enrollment, interstitial lung disease, untreated severe obstructive sleep apnea)
- Pre-deployment history of cardiovascular or pulmonary disease including coronary artery disease, left ventricular ejection fraction ≤45% or heart failure with preserved ejection fraction requiring diuretic therapy, arrhythmia, valvular abnormality, chronic obstructive pulmonary disease, asthma (excluding childhood asthma that did not persist into adulthood), interstitial lung disease, or pulmonary hypertension
- Body mass index <18.5 or >45
- Anemia with hemoglobin <10 g/dl
- Disorders that adversely influence exercise ability (e.g. arthritis or peripheral vascular disease)
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 |
|---|---|---|
| Exercise trainingParticipants will complete a 12-week exercise training program. The program consists of 3x/week HIIT sessions on an upright stationary bicycle (~40 minutes each) and 3x/week home aerobic sessions (any type of aerobic exercise; 45 minutes each). | Behavioural | Veterans with respiratory symptoms |
Primary outcome
Maximum Oxygen Consumption (VO2max)
Time frame: Up to 1 hour
Obtained via metabolic cart during maximal cardiopulmonary exercise testing, in ml/kg/min
Health-related Quality of Life by Short Form 36 (SF-36) Questionnaire
Time frame: Up to 1 hour
Units, Range 0-100 with higher scores indicating more favorable health state
4 secondary outcomes
Left Ventricular Ejection Fraction Measured by Transthoracic Echocardiogram
Time frame: Up to 1 hour
Tricuspid Annular Plane Systolic Excursion Measured by Transthoracic Echocardiogram
Time frame: Up to 1 hour
Plasma Acylcarnitine 10:0 Measured by Peripheral Venous Metabolomics (Ultra-high Performance Liquid Chromatography Coupled to Mass Spectrometry)
Time frame: Up to 1 hour
Feasibility of Exercise Program, Reported by Participant and Measured by Responses to Questionnaire
Time frame: Up to 1 hour
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Occupational Exposure
Recruiting
Consecutive Occupational Heat Exposure With and Without Overnight Cooling
Body Temperature Changes, Heat Stress
Enrolling by invitation
Personalizing Veterans' Lung Cancer Screening and Diagnosis
Lung Cancer Screening, Military Service-related Environmental and Occupational Exposures
Not yet recruiting
Progressive Heat Exposure and Physiological Strain
Body Temperature Changes, Heat Stress
RecruitingObservational study
Clinical Utility of LIBS Multi-Element Imaging and the IFF Algorithm in Chronic Lung Diseases
Interstitial Lung Diseases (ILD), Pulmonary Emphysema
RecruitingObservational study
Human Observatory Study
Aging, Mortality
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. This study is not recruiting at the moment.
William Cornwell, MD, MSCS principal investigator
University of Colorado, Denver
Lindsay Forbes, MD principal investigator
University of Colorado, Denver
Silpa Krefft, MD principal investigator
VA Eastern Colorado Health Care System
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training in people with Occupational Exposure, run by University of Colorado, Denver at 2 sites 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 6 inclusion and 8 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: finished, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
Yes. Results are posted in the registry (first posted 29 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Oxygen Consumption (VO2max) (time frame: Up to 1 hour). 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 29 Jan 2026; AzTrials last refreshed its copy on 7 Nov 2026.