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| Name | Class |
|---|---|
| VA Office of Research and Development | FED |
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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:
Study participants will complete the following:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Veterans with respiratory symptoms | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Left Ventricular Ejection Fraction Measured by Transthoracic Echocardiogram | % | Up to 1 hour |
| Tricuspid Annular Plane Systolic Excursion Measured by Transthoracic Echocardiogram | mm |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | United States | ||
| VA Eastern Colorado Health Care System |
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| ID | Title | Description |
|---|---|---|
| FG000 | Veterans With Respiratory Symptoms | Veterans with respiratory symptoms meeting the inclusion and exclusion criteria |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Veterans With Respiratory Symptoms | Veterans with respiratory symptoms meeting the inclusion and exclusion criteria |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Oxygen Consumption (VO2max) | Obtained via metabolic cart during maximal cardiopulmonary exercise testing, in ml/kg/min | Posted | Median | Inter-Quartile Range | ml/kg/min | Up to 1 hour |
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From enrollment until end of follow-up, up to 4 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Veterans With Respiratory Symptoms | Veterans with respiratory symptoms meeting the inclusion and exclusion criteria |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lindsay Forbes | University of Colorado | 303-724-4020 | lindsay.forbes@cuanschutz.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 1, 2024 | Jul 28, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 1, 2024 | Jul 28, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Up to 1 hour |
| 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 |
| Feasibility of Exercise Program, Reported by Participant and Measured by Responses to Questionnaire | Score, Likert scale indicating agreement with the statement "I was able to complete the scheduled high-intensity interval training sessions," 5-point range from 1 = "Strongly disagree" to 5 = "Strongly agree" with "Strongly agree" indicating greater agreement | Up to 1 hour |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| 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 | Posted | Median | Inter-Quartile Range | Units on a scale, Range 0-100 | Up to 1 hour |
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|
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| Secondary | Left Ventricular Ejection Fraction Measured by Transthoracic Echocardiogram | % | Two participants were unable to complete transthoracic echocardiography due to scheduling constraints | Posted | Median | Inter-Quartile Range | % of blood | Up to 1 hour |
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| Secondary | Tricuspid Annular Plane Systolic Excursion Measured by Transthoracic Echocardiogram | mm | Two participants were unable to complete transthoracic echocardiography due to scheduling constraints | Posted | Median | Inter-Quartile Range | mm | Up to 1 hour |
|
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| Secondary | Plasma Acylcarnitine 10:0 Measured by Peripheral Venous Metabolomics (Ultra-high Performance Liquid Chromatography Coupled to Mass Spectrometry) | Relative ion count | Posted | Median | Inter-Quartile Range | Relative ion count | Up to 1 hour |
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| Secondary | Feasibility of Exercise Program, Reported by Participant and Measured by Responses to Questionnaire | Score, Likert scale indicating agreement with the statement "I was able to complete the scheduled high-intensity interval training sessions," 5-point range from 1 = "Strongly disagree" to 5 = "Strongly agree" with "Strongly agree" indicating greater agreement | One participant withdrew from study | Posted | Median | Inter-Quartile Range | Scores on a Likert scale, 5-point range | Up to 1 hour |
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| 0 |
| 12 |
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| 12 |
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