Impact Of Adding Inspiratory Muscle Training To Cardiac Rehabilitation On Exercise Responses In Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in locomotor muscle blood flow during exercise
研究概览
简要总结
The purpose of this study is to compare the impact of inspiratory muscle training (IMT) combined with cardiac rehabilitation (CR) on cardiovascular function in patients with heart failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, 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
- •HFrEF Patients: (≥18 yrs) receiving guideline directed pharmacologic medical therapy for >6 weeks (those with contraindications to medical therapy will meet inclusion criteria), NYHA symptoms I-III, no hospitalizations in the >3 months, have a body mass index ≤45 kg/m2, currently be non-smokers with <30 pack year history and be able to exercise (i.e. without significant orthopedic limitations or musculoskeletal disorders limiting their ability to exercise).
排除标准
- •sustained ventricular tachycardia and/or ventricular fibrillation within 21 days of visit 1;
- •second or third degree heart block;
- •body mass index >45 kg/m2;
- •current smokers and/or smoking history >30 pack years;
- •pregnant women (testing will be done by research team if requested);
- •glomerular filtration rate of <30 mL/min/1.73m2 (initial screen via clinical record within the past 6 months and this will be assessed on Visit 1);
- •individuals who are not able to engage in exercise;
- •symptomatic peripheral artery disease;
- •asthmatic patients with a low symptom perception and suffer frequency, severe exacerbations or with an abnormally low perception of dyspnea;
- •ruptured eardrum or any other condition of the ear;
- •history of spontaneous pneumothorax or osteoporosis with a history of rib fractures;
- •history of lung disease.
- •For individuals agreeing to undergo dual energy x-ray absorptiometry (DEXA) scanning for measurement of body composition as part of their study visit, additional exclusion criteria apply: recently administered gastrointestinal contrast or radionuclides; severe degenerative changes or fracture deformity in measurement areas; or inability to attain correct position and/or remain motionless for the measurement period.
研究组 & 干预措施
Inspiratory muscle training (IMT)
IMT performed at 40% maximal inspiratory pressure (MIP) for 30 minutes 3 days a week for 12 weeks.
干预措施: Powerbreathe (Device)
SHAM
IMT performed at 5% maximal inspiratory pressure (MIP) for 30 minutes 3 days a week for 12 weeks.
干预措施: Powerbreathe (Device)
结局指标
主要结局
Change in locomotor muscle blood flow during exercise
时间窗: Baseline, 12 weeks
Locomotor muscle blood flows will be measured via Doppler-ultrasound. This will be measured in mL/min.
Change in respiratory muscle cost of breathing (VO2)
时间窗: Baseline, 12 weeks
Respiratory muscle cost of breathing is the oxygen uptake (VO2) to the respiratory muscles. Respiratory muscle VO2 is expressed as milliliters of oxygen per kilogram of body mass per minute.
次要结局
未报告次要终点
研究者
Joshua R. Smith
Principal Investigator
Mayo Clinic