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

Occupational Exposure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05849168
• Other study ID #: 22-2069
• Status: Recruiting
• Phase: N/A
• Start date: May 8, 2023
• Est. completion date: May 2024

Study information

• Verified date: November 2023
• Source: University of Colorado, Denver
• Contact: Lindsay Forbes, MD
• Phone: (720)892-6017
• Email: lindsay.forbes[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Occupational Exposure
• Respiration Disorders
• Respiratory Tract Diseases

Intervention

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).

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado
United States	VA Eastern Colorado Health Care System	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum oxygen consumption (VO2max)	ml/kg/min	Up to 1 hour
Primary	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	Left ventricular ejection fraction measured by transthoracic echocardiogram		Up to 1 hour
Secondary	Tricuspid annular plane systolic excursion measured by transthoracic echocardiogram	mm	Up to 1 hour
Secondary	Plasma acylcarnitine 10:0 measured by peripheral venous metabolomics (ultra-high performance liquid chromatography coupled to mass spectrometry)	Relative ion count	Up to 1 hour
Secondary	Feasibility of exercise program, reported by participant and measured by responses to questionnaire	Score, Likert scale, 5-point range from "Strongly disagree" to "Strongly agree" with "Strongly agree" indicating greater agreement	Up to 1 hour