Right Ventricular Response to Exercise Among Patients With Chronic Obstructive Pulmonary Disease (ReV UP COPD)
Phenotyping Resting and Exertional Right Ventricular Dysfunction Among Patients With Chronic Obstructive Pulmonary Disease
研究概览
详细说明
This study will determine patterns of right ventricular (RV) response to aerobic exercise in patients with chronic obstructive pulmonary disease (COPD) and will design a targeted exercise intervention to improve RV response. We will study 60 patients with COPD. Participants will complete cardiopulmonary exercise testing (CPET) and transthoracic echocardiography (TTE) during rest, moderate- and high-intensity exercise. A subset of participants (n=16) who have been recommended to undergo clinical right heart catheterization will be recruited for the primary study with additional invasive pressure-volume analysis during the CPET. This testing will be used to validate measures of RV function obtained through noninvasive testing. The sample size was selected based upon our preliminary data and statistical analysis plans.
To test whether an exercise intervention targeted to RV response to exercise is feasible for patients, 12 participants will complete a targeted exercise training intervention based on their RV contractile response during baseline testing. This intervention will include participants who demonstrate RV contractility increase to moderate- but not high-intensity exercise. We will test the feasibility of a moderate-intensity interval training program. Participants will complete exercise training sessions 3x/week for 12 weeks. Exercise training will be performed on an upright stationary bicycle. Following the exercise training intervention, participants will repeat CPET and TTE. They will also complete a health-related quality of life questionnaire before and after the exercise training intervention.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Lindsay Forbes, MD
- 电话号码:(303)724-4020
- 邮箱:lindsay.forbes@cuanschutz.edu
学习地点
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Colorado
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Aurora、Colorado、美国、80045
- 招聘中
- University of Colorado Anschutz Medical Campus
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接触:
- Lindsay Forbes, MD
- 电话号码:303-724-4020
- 邮箱:lindsay.forbes@cuanschutz.edu
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- COPD (determined by ratio of forced expiratory volume in 1 second to forced vital capacity [FEV1/FVC] <0.7)
- Age >= 40 years
Exclusion Criteria:
- Exacerbation of COPD in the 3 months prior to enrollment
- Change in COPD therapy in the 3 weeks prior to enrollment
- Requirement of >6 LPM supplemental oxygen at rest
- Requirement of >10 LPM supplemental oxygen with exertion
- Active/uncontrolled cardiovascular disease (e.g. hypertension with blood pressure >150/100 despite antihypertensives; coronary artery disease with angina; left ventricular ejection fraction ≤40%; uncontrolled arrhythmia; pulmonic, mitral or aortic valvular abnormality greater than mild in severity; tricuspid regurgitation greater than moderate in severity)
- Volume overload (jugular vascular distension or greater than trace peripheral edema)
- World Health Organization Functional Class IV
- Known pulmonary hypertension with mean pulmonary artery pressure >45 mmHg
- Untreated severe obstructive sleep apnea and/or obesity hypoventilation syndrome
- Active malignancy (other than skin)
- Medical conditions that limit exercise on an upright stationary bicycle (e.g. severe osteoarthritis, imbalance/gait instability, etc.)
- Pregnancy
- Body mass index <18 or >35
- Hematocrit <25% or >55%
- For subset undergoing right heart catheterization, chronic anticoagulation that is unable to be held for the study visit
- For subset undergoing right heart catheterization or exercise training, forced expiratory volume in 1 second of <20%
- For exercise training, already engaged in routine exercise training (>30 minutes at >3 METs 3 times/week or more)
- For exercise training, inability to complete initial in-person exercise training sessions for approximately 35 minutes 3x/week for 3 weeks (followed by exercise training sessions with an option for hybrid remote/in-person participation)
- For exercise training with an option for hybrid remote exercise training, any medical conditions which threaten the safety of remote exercise training (e.g. imbalance/gait instability, etc.).
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:慢性阻塞性肺疾病
参与者将在静息状态及中高强度运动期间完成测试,以识别右心室反应模式。
根据基线测试符合条件并决定参加可选运动训练计划的参与者,将完成运动训练,随后进行重复测试,以确定运动训练对右心室功能障碍的影响。
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Exercise training will include moderate-intensity interval training 3x/week.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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经胸超声心动图测量的右心室收缩力
大体时间:最多1小时
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整体纵向应变,以绝对百分比测量
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最多1小时
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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电导导管测量右心室收缩力
大体时间:最多 1 小时
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最大压力变化率,dP/dtmax,单位为 mmHg/sec
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最多 1 小时
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最大耗氧量(VO2max)
大体时间:最多 1 小时
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升/分钟
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最多 1 小时
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健康相关生活质量简表 36 (SF-36) 问卷
大体时间:长达 1 小时
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单位,范围 0-100,分数越高表示健康状况越好
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长达 1 小时
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运动训练可行性
大体时间:4个月
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完成运动训练的比例
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4个月
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运动训练安全
大体时间:4个月
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报告或观察到的不良事件
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4个月
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经胸超声心动图测量的右心室收缩功能
大体时间:最多 1 小时
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经胸超声心动图测量的面积变化分数,以百分比表示
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最多 1 小时
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经胸超声心动图测量的右心室收缩功能
大体时间:最多1小时
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经胸超声心动图测量的三尖瓣环平面收缩期位移,单位为厘米
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最多1小时
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合作者和调查者
调查人员
- 首席研究员:Lindsay Forbes, MD、University of Colorado, Denver
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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