The Efficacy of Inspiratory Muscle Strength Training on Coronary Blood Flow in Patients With Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Global myocardial flow reserve
研究概览
简要总结
The goal of this single-site, parallel-group, double-blind, sham-controlled randomized control trial is to examine the effect of high-intensity inspiratory muscle strength training (IMST) on coronary blood flow assessed using positron emission tomography coronary perfusion imaging in patients with coronary artery disease (CAD).
The main question it aims to answer are:
• if high-intensity IMST will improve coronary blood flow in patients with CAD, which could be assessed using positron emission tomography coronary perfusion imaging.
Participants will be asked to complete the 8-week high-intensity or low-intensity IMST. Researchers will compare high and low-intensity IMST groups to see if coronary blood flow increases after IMST.
详细描述
Coronary artery disease (CAD) is a leading cause of morbidity and mortality. With the aging population, increasing number of patients with CAD has frailty and immobility. The health benefits of traditional aerobic exercise have been well-established; however, alternative exercise programs, such as inspiratory muscle training (IMST), may provide greater merits. IMST is a form of exercise that engages the diaphragm and accessory respiratory muscles to repeatedly inhale against resistance, which can be achieved in less time and widely applicable even for immobile or frail patients compared to conventional aerobic exercise. Since barriers to conventional exercise training include immobility, lack of time, and access to facilities, IMST may be a beneficial exercise form that can overcome those factors. A previous study has shown that high-intensity IMT can lower blood pressure and improved vascular endothelial function. Improvements in endothelial function of coronary arteries could improve coronary blood flow, leading to the improvement of anginal symptoms as well as quality of life. IMST might offer a widely applicable, feasible, time-efficient form of training for CAD patients. Our study will examine the preliminary efficacy of IMST on coronary blood flow in patients with CAD.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Global myocardial flow reserve
时间窗: Through study completion, an average of 8 weeks
Change in global myocardial flow reserve on positron emission tomography coronary perfusion imaging before and after IMST
Global stress myocardial blood flow
时间窗: Through study completion, an average of 8 weeks
Change in global stress myocardial blood flow on positron emission tomography coronary perfusion imaging before and after IMST
次要结局
- Mean segmental (17-segment model) myocardial flow reserve(Through study completion, an average of 8 weeks)
- General quality of life(Through study completion, an average of 8 weeks)
- Angina symptom(Through study completion, an average of 8 weeks)
- Respiratory Muscle Strength(Through study completion, an average of 8 weeks)
- Global coronary vascular resistance at stress and rest(Through study completion, an average of 8 weeks)
- Maximum myocardial flow reserve(Through study completion, an average of 8 weeks)
- Maximum coronary vascular resistance at stress and rest(Through study completion, an average of 8 weeks)
- Mean segmental (17-segment model) myocardial blood flow at stress and rest(Through study completion, an average of 8 weeks)
- Summed stress score, summed rest score, and summed difference score(Through study completion, an average of 8 weeks)
- % left ventricular ischemia(Through study completion, an average of 8 weeks)
- Global rest myocardial blood flow(Through study completion, an average of 8 weeks)
- Maximum myocardial blood flow at rest and stress(Through study completion, an average of 8 weeks)
- Adherence of IMST program(Through study completion, an average of 8 weeks)
- Maximal segmental (17-segment model) myocardial blood flow at stress and rest(Through study completion, an average of 8 weeks)
- Resting blood pressure(Through study completion, an average of 8 weeks)