Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:28 PM
Ignite Modification Date:
2025-12-24 @ 5:28 PM
NCT ID:
NCT05849168
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05849168
Study Brief:
Protocol Section:
NCT05849168