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Completed

NCT Number: NCT05849168

High-Intensity Interval Training to Improve Symptoms of Deployment-Related Respiratory Disease

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:

1. Do veterans with new respiratory symptoms after deployment have heart or lung abnormalities that contribute to difficulty exercising? 2. Does high-intensity interval training (HIIT) improve fitness and symptoms?

Study participants will complete the following:

1. Study Visits 1A and 1B: Exercise test (VO2max test), echocardiogram (heart ultrasound), blood tests, questionnaires 2. 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) 3. Study Visits 2A and 2B: Exercise test (VO2max test), echocardiogram (heart ultrasound), blood tests, questionnaires

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Exercise Training

Behavioral

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).

Primary outcomes

  1. Maximum Oxygen Consumption (VO2max)

    Time frame: Up to 1 hour

    Obtained via metabolic cart during maximal cardiopulmonary exercise testing, in ml/kg/min

  2. 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

Secondary outcomes

  1. Left Ventricular Ejection Fraction Measured by Transthoracic Echocardiogram

    Time frame: Up to 1 hour

    %

  2. Tricuspid Annular Plane Systolic Excursion Measured by Transthoracic Echocardiogram

    Time frame: Up to 1 hour

    mm

  3. Plasma Acylcarnitine 10:0 Measured by Peripheral Venous Metabolomics (Ultra-high Performance Liquid Chromatography Coupled to Mass Spectrometry)

    Time frame: Up to 1 hour

    Relative ion count

  4. Feasibility of Exercise Program, Reported by Participant and Measured by Responses to Questionnaire

    Time frame: Up to 1 hour

    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

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • VA Office of Research and Development

Registry information

Official study title

High-Intensity Interval Training (HIIT) to Improve Symptoms of Deployment-Related Respiratory Disease - A Pilot Study

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 8, 2023
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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