Novel Cardiac Rehabilitation in Patients Heart Failure and Preserved Ejection Fraction
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Change in peak oxygen consumption from baseline
研究概览
简要总结
Patients with HFpEF suffer from exercise intolerance, increased risk for hospitalization and mortality, and poor QOL. Unlike patients with HFrEF, no drug or device therapies appear to be consistently beneficial in treating these problems. However, increasing evidence suggests that exercise training is effective for both partially reversing exercise intolerance and improving quality of life in these patients. Most such trials to date have been conducted in controlled research setting, versus integrating these patients in to a standard CR program. Also, since functional capacity is related to outcomes in these patients, exercise strategies aimed at further improving fitness are warranted. One such strategy is using higher intensity interval training (HIIT) in the CR setting, a strategy shown to be effective in patients with other types of CVD. This project is designed to test the feasibility of incorporating these patients into the CR setting, and training them using a methodology (i.e., HIIT) already shown to yield (in other patients with CVD) greater gains in fitness when compared to what was achieved using standard MCT alone.
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
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •NYHA class II or III symptoms
- •Referred by physician to CR with echocardiographic evidence of HFpEF defined as an ejection fraction ≥ 50 % and moderate to severe (grade II-III) diastolic dysfunction.
- •≥ 50 years of age
- •Free of orthopedic or other medical problems that would limit participation in CR
- •Peak VO2 on baseline cardiopulmonary exercise test (CPX) < 24 mL/kg/min in men and <21 mL/kg/min in women
排除标准
- •Systolic dysfunction, per ejection fraction < 50%; those with mild (grade I) diastolic dysfunction
- •Initial clinical responses observed during first 3 visits in CR or baseline exercise test that would preclude participation in study over-all (e.g., new onset/troublesome arrhythmia that warrants further investigation) or undergoing HIIT (e.g., claudication, balance issue)
- •Patients with exercise induced angina during CR or CPX testing or ST segment depression representative of myocardial ischemia during CPX testing
- •Pregnant or planning to become pregnant
- •Any patient recently hospitalized for heart failure will have to wait at least 2 weeks before starting CR, or until clinically stable per physician(whichever time period is greater)
- •Atrial fibrillation
结局指标
主要结局
Change in peak oxygen consumption from baseline
时间窗: Change from baseline at 10-12 weeks
次要结局
未报告次要终点
研究者
Steven J. Keteyian
Principal Investigator
Henry Ford Health System