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

Sponsor

University of Colorado, Denver (Other)

Overall Status

Recruiting

CT.gov ID

NCT05849168

Collaborator

VA Office of Research and Development (U.S. Fed)

Enrollment

Locations

Arm

11.8

Anticipated Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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:

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 Visit 1: 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 Visit 2: Exercise test (VO2max test), echocardiogram (heart ultrasound), blood tests, questionnaires

Condition or Disease	Intervention/Treatment	Phase
Occupational Exposure	Behavioral: Exercise training	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

12 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 8, 2023

Anticipated Primary Completion Date :

May 1, 2024

Anticipated Study Completion Date :

May 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Veterans with respiratory symptoms	Behavioral: Exercise training 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).

Arm

Intervention/Treatment

Experimental: Veterans with respiratory symptoms

Behavioral: Exercise training

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).

Outcome Measures

Primary Outcome Measures

Maximum oxygen consumption (VO2max) [Up to 1 hour]
ml/kg/min
Dyspnea measured by St. George's Respiratory Questionnaire [Up to 1 hour]
Units, Range 0-100 with higher scores indicating greater limitation

Secondary Outcome Measures

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]
mm
Plasma acylcarnitine 10:0 measured by peripheral venous metabolomics (ultra-high performance liquid chromatography coupled to mass spectrometry) [Up to 1 hour]
Relative ion count
Health-related quality of life by Short Form 36 (SF-36) questionnaire [Up to 1 hour]
Units, Range 0-100 with higher scores indicating more favorable health state
Feasibility of exercise program, reported by participant and measured by responses to questionnaire [Up to 1 hour]
Score, Likert scale, 5-point range from "Strongly disagree" to "Strongly agree" with "Strongly agree" indicating greater agreement

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 >150/100 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 requiring diuretic therapy, arrhythmia, valvular abnormality, diabetes with HbA1c >7.5%, active tobacco use, chronic obstructive pulmonary disease Global Initiative for Lung Disease [GOLD] E i.e. two or more exacerbations in the last year or one or more hospitalization for exacerbation in the last year, persistent asthma that is classified as moderate or severe despite therapy, interstitial lung disease, untreated obstructive sleep apnea, or pulmonary hypertension)
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 >35
Anemia with hemoglobin <11 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado Anschutz Medical Campus	Aurora	Colorado	United States	80045
2	VA Eastern Colorado Health Care System	Aurora	Colorado	United States	80045

Sponsors and Collaborators

University of Colorado, Denver
VA Office of Research and Development

Investigators

Principal Investigator: 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