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

Primary Purpose

Occupational Exposure

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise training
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Occupational Exposure focused on measuring exercise tolerance, exercise therapy, airborne hazards, deployment-related respiratory disease, veterans, burn pit

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Colorado Anschutz Medical Campus
  • VA Eastern Colorado Health Care SystemRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Veterans with respiratory symptoms

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Left ventricular ejection fraction measured by transthoracic echocardiogram
Tricuspid annular plane systolic excursion measured by transthoracic echocardiogram
mm
Plasma acylcarnitine 10:0 measured by peripheral venous metabolomics (ultra-high performance liquid chromatography coupled to mass spectrometry)
Relative ion count
Health-related quality of life by Short Form 36 (SF-36) questionnaire
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
Score, Likert scale, 5-point range from "Strongly disagree" to "Strongly agree" with "Strongly agree" indicating greater agreement

Full Information

First Posted
April 17, 2023
Last Updated
May 8, 2023
Sponsor
University of Colorado, Denver
Collaborators
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT05849168
Brief Title
High-Intensity Interval Training to Improve Symptoms of Deployment-Related Respiratory Disease
Official Title
High-Intensity Interval Training (HIIT) to Improve Symptoms of Deployment-Related Respiratory Disease - A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 8, 2023 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Occupational Exposure
Keywords
exercise tolerance, exercise therapy, airborne hazards, deployment-related respiratory disease, veterans, burn pit

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Veterans with respiratory symptoms
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Exercise training
Intervention Description
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 Outcome Measure Information:
Title
Maximum oxygen consumption (VO2max)
Description
ml/kg/min
Time Frame
Up to 1 hour
Title
Dyspnea measured by St. George's Respiratory Questionnaire
Description
Units, Range 0-100 with higher scores indicating greater limitation
Time Frame
Up to 1 hour
Secondary Outcome Measure Information:
Title
Left ventricular ejection fraction measured by transthoracic echocardiogram
Time Frame
Up to 1 hour
Title
Tricuspid annular plane systolic excursion measured by transthoracic echocardiogram
Description
mm
Time Frame
Up to 1 hour
Title
Plasma acylcarnitine 10:0 measured by peripheral venous metabolomics (ultra-high performance liquid chromatography coupled to mass spectrometry)
Description
Relative ion count
Time Frame
Up to 1 hour
Title
Health-related quality of life by Short Form 36 (SF-36) questionnaire
Description
Units, Range 0-100 with higher scores indicating more favorable health state
Time Frame
Up to 1 hour
Title
Feasibility of exercise program, reported by participant and measured by responses to questionnaire
Description
Score, Likert scale, 5-point range from "Strongly disagree" to "Strongly agree" with "Strongly agree" indicating greater agreement
Time Frame
Up to 1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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 >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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lindsay Forbes, MD
Phone
(720)892-6017
Email
lindsay.forbes@cuanschutz.edu
First Name & Middle Initial & Last Name or Official Title & Degree
William Cornwell, MD, MSCS
Email
william.cornwell@cuanschutz.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Cornwell, MD, MSCS
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lindsay Forbes, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Silpa Krefft, MD
Organizational Affiliation
VA Eastern Colorado Health Care System
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lindsay "Shelley" Forbes, MD
Phone
720-892-6017
Email
lindsay.forbes@cuanschutz.edu
Facility Name
VA Eastern Colorado Health Care System
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lindsay "Shelley" Forbes, MD
Phone
720-892-6017
Email
lindsay.forbes@cuanschutz.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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