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

NCT05849168 | Completed Results

• 1 other identifier: 22-2069
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief 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. The main questions it aims to answer are:

1. 1.Do veterans with new respiratory symptoms after deployment have heart or lung abnormalities that contribute to difficulty exercising?
2. 2.Does high-intensity interval training (HIIT) improve fitness and symptoms?
3. 3.Study Visits 1A and 1B: Exercise test (VO2max test), echocardiogram (heart ultrasound), blood tests, questionnaires
4. 4.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)
5. 5.Study Visits 2A and 2B: Exercise test (VO2max test), echocardiogram (heart ultrasound), blood tests, questionnaires

Conditions

Occupational Exposure

Keywords

exercise tolerance; exercise therapy; airborne hazards; deployment-related respiratory disease; veterans; burn pit

Outcome Measures

Primary Outcomes (2)

• Maximum Oxygen Consumption (VO2max)

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

  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

  Up to 1 hour

Secondary Outcomes (4)

• Left Ventricular Ejection Fraction Measured by Transthoracic Echocardiogram

  Up to 1 hour

• Tricuspid Annular Plane Systolic Excursion Measured by Transthoracic Echocardiogram

  Up to 1 hour

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

  Up to 1 hour

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

  Up to 1 hour

Study Arms (1)

Veterans with respiratory symptoms

EXPERIMENTAL

Behavioral: Exercise training

Interventions

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).

Veterans with respiratory symptoms

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• VA Office of Research and Development: collaborator

Study Sites (2)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

VA Eastern Colorado Health Care System

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Lindsay Forbes
• Organization: University of Colorado

lindsay.forbes@cuanschutz.edu

303-724-4020

Study Officials

• William Cornwell, MD, MSCS

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

• Lindsay Forbes, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

• Silpa Krefft, MD

  VA Eastern Colorado Health Care System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: May 8, 2023
• Study Start: November 27, 2023
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: January 29, 2026
• Results First Posted: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)