The Acute and Chronic Benefits of Passive Heat Therapy for People With COPD
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Mean 24-hour ambulatory blood pressure following chronic passive heat therapy
研究概览
简要总结
People with Chronic Obstructive Pulmonary Disease (COPD) often develop high blood pressure and heart disease due to their sedentary lifestyle and difficulty exercising. The investigators will test if heating can mimic the health benefits of exercise by monitoring the increase in leg blood-flow using ultrasound during a 45-minute hot-water footbath. The patients will then undergo 6-weeks of hot-water footbaths to examine whether the changes to blood-flow lead to improvements in blood pressure and other indicators of heart disease risk.
详细描述
People with COPD are at higher risk of developing cardiovascular disease (CVD). While exercise training is a potent therapy for CVD, people with COPD have a low tolerance for exercise due to dyspnea and premature muscle fatigue. Thus, there is a need to develop more effective strategies to improve CVD risk in people with COPD. A novel way to reduce blood pressure and enhance arterial health is with passive heat therapy (PHT). An acute 45-min bout of lower limb hot-water immersion has been shown to increase leg blood flow and reduce blood pressure in healthy older adults, suggesting that PHT could have similar hypotensive and anti-atherosclerotic effects as exercise. Augmenting leg blood flow with PHT may also have functional benefits by reducing peripheral muscle fatigue and improving exercise tolerance. No study to date has looked at the acute and chronic hemodynamic and vascular responses to PHT in people with COPD, nor whether it can acutely or chronically improve exercise tolerance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Blinding of the participant to the condition (heat therapy or sham) is not possible. Data that needs to be analyzed (i.e. ultrasound videos for blood flow and FMD) will be coded by a team member that is not involved in data collection or analysis. The outcomes assessor will be blind to the participant, condition and time point of the file. Breaking of the code will only occur when all data analysis is complete.
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-smoking individuals
- •>40 years of age
- •Stable (exacerbation free for >6 weeks), moderate-to-severe COPD (post bronchodilator FEV1/FVC <lower limit of normal and FEV1 z-score <2.51)
排除标准
- •Performing structured exercise training (i.e. pulmonary rehabilitation)
- •Have advanced cardiac or cerebrovascular disease (i.e. a history of heart failure, previous stroke or myocardial infarction)
- •Have uncontrolled hypertension (>160/95 mmHg at rest)
- •Have hypotension (<110/60 mmHg)
- •Are taking Beta Blockers
- •Regularly (>1/week) have hot baths (>30 min) or use a hot tub or sauna.
- •Exclusion Criteria for exercise outcomes:
- •Have resting blood pressure > 150/95 mmHg
- •On supplemental oxygen for hypoxemia.
- •Musculoskeletal pain that limits their ability to perform stationary cycling.
结局指标
主要结局
Mean 24-hour ambulatory blood pressure following chronic passive heat therapy
时间窗: 6 weeks
The change in 24-hour ambulatory systolic, diastolic and mean arterial blood pressure from baseline to post intervention.
次要结局
- Flow mediated dilation of the superficial femoral artery following chronic passive heat therapy.(6 weeks)
- The acute changes in superficial femoral artery shear stress from a single bout of passive heat therapy(During procedure: 60-minutes)
- Exercise tolerance following chronic passive heat therapy(6 weeks)
- Arterial stiffness following chronic passive heat therapy(6 weeks)
- The acute changes in leg blood flow from a single bout of passive heat therapy(During procedure: 60-minutes)
研究者
Neil Eves
Professor
University of British Columbia