A Randomized Trial of Moderate Intensity Exercise Training in Patients With Hypertrophic Cardiomyopathy
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Improvement in ability to perform activities and tasks.
研究概览
简要总结
The long term health and cardiovascular benefits of a regular exercise program have been well-established. National guidelines recommend involvement in moderate aerobic fitness (i.e. walking, bicycling, light jogging, swimming) for patients with hypertrophic cardiomyopathy (HCM). However, data on potential benefits of recreational exercise, useful parameters for risk stratification, and methods of devising individual exercise prescriptions are completely lacking. The specific aims of this study are: 1) to devise a safe moderate intensity exercise training program in patients with HCM, and 2) to determine whether exercise training improves ability to perform activities and tasks, heart size and function, and quality of life in patients with HCM.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages 18 - 80 years old.
- •Diagnosis of hypertrophic cardiomyopathy, defined by the presence of unexplained left-ventricular hypertrophy (wall thickening) > 13 mm in any wall segment.
- •Exercise £ 30 minutes, 1 day per week for the previous 3 months.
- •Agreement to be a participant in the study protocol and willing/able to return for follow-up.
排除标准
- •History of exercise-induced syncope or arrhythmias (ventricular tachycardia or non-sustained ventricular tachycardia).
- •Medically refractory LV outflow tract obstruction being evaluated for septal reduction therapy.
- •Less than 3 months post septal reduction therapy (surgery or catheter based intervention).
- •Hypotensive response to exercise (> 20 mmHg drop in systolic blood pressure from peak blood pressure to post exercise blood pressure).
- •ICD placement in last 3 months or scheduled.
- •Life expectancy less than 12 months.
- •Inability to exercise due to orthopedic or other non-cardiovascular limitations.
结局指标
主要结局
Improvement in ability to perform activities and tasks.
时间窗: 4 months
次要结局
- Improvement in heart size and function and quality of life (QOL).(4 months)