NCT05849168已完成不适用
High-Intensity Interval Training (HIIT) to Improve Symptoms of Deployment-Related Respiratory Disease - A Pilot Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Maximum Oxygen Consumption (VO2max)
研究概览
简要总结
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 Visits 1A and 1B: 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 Visits 2A and 2B: Exercise test (VO2max test), echocardiogram (heart ultrasound), blood tests, questionnaires
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Veterans with respiratory symptoms
Experimental
干预措施: Exercise training (Behavioral)
结局指标
主要结局
Maximum Oxygen Consumption (VO2max)
时间窗: Up to 1 hour
Obtained via metabolic cart during maximal cardiopulmonary exercise testing, in ml/kg/min
Health-related Quality of Life by Short Form 36 (SF-36) Questionnaire
时间窗: Up to 1 hour
Units, Range 0-100 with higher scores indicating more favorable health state
次要结局
- 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)
研究者
研究点 (2)
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