Post Myocardial Infarction's Rehabilitation Guided by Heart Rate Variability
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- gain of VO2max
研究概览
简要总结
Cardiac rehabilitation reduces morbidity and mortality after myocardial infarction (MI) and improve the sympathovagal balance. The autonomic nervous system (ANS) can be explored by the variation of heart rate (HRV). The HRV is a fatigue marker and guides the athletes training programs. A smartphone app can measure the HRV via a heart rate monitor.
The main study objective is to compare the effect on the functional capacities of a re-training adapted to the HRV compared to a standard program in the post-MI The secondary objective is to compare the patients' quality of life according to the rehabilitation program and to validate the HRV smartphone app.
This is a prospective, multicenter study. Post-MI patients treated with angioplasty with a LVEF> 40% are randomized into 2 groups: HRV (re-training adapted to HRV daily: 10W decrease or increase in workload according to the HRV) or control (continuous training in SV1). Patients underwent a cardiopulmonary test, a walking test (TM6) and a SF36 questionaries' at the entrance and exit. The taking of HRV was done every morning in a standardized way via the smartphone app during the 20 re-training sessions.
详细描述
Description of the study:
Patients with myocardial infarction (STEMI or NSTEMI) without alteration of left ventricle systolic function, agreeing to participate at a cardiac rehabilitation program will be included in the study and randomized into two groups:
- Group A (= control): standard rehabilitation protocol according to the personal functional capacities (measured by a cardiopulmonary test on the beginning of the cardiac reeducation.)
- Group B (= strategy to the study): individualization of the rehabilitation program according to the daily HRV measure and the personal functional capacity (measured by a cardiopulmonary test on the program beginning).
The duration of the rehabilitation program will be 4 weeks with 5 training sessions per week (Monday to Friday), or 20 training sessions. At the end of the program, patients will benefit from an assessment of functional abilities and their quality of life.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Man, Woman ≥18 years old and <70 years old
- •STEMI or NSTEMI having undergone angioplasty revascularization at least 8 day before the beginning of reeducation
- •Sinus rhythm
- •LVEF> 40% (Simpson Biplane echocardiography
排除标准
- •Contraindications to cardiac re-training:
- •Ventricular or supraventricular rhythm disorder
- •Heart failure.
- •Pericardial effusion.
- •STEMI or NSTEMI <J8
- •NSTEMI or STEMI , post revascularization by bypass surgery
- •Non-sinus rhythm
- •Comorbidity preventing all sports activity: severe AOMI; amputation; neurological disorder, hemiplegia.
- •Pathology leading to modifications of the HRV:
- •Chronic lung disease
- •Renal insufficiency with clearance <30 ml / min (MDRD)
- •LVEF <40%
- •Electrical cardiac stimulation
- •Linked to the person:
- •Protected Majors
- •People unable to express their consent.
- •Pregnant woman
研究组 & 干预措施
control
standard rehabilitation protocol according to the personal functional capacities (measured by a cardiopulmonary test on the beginning of the cardiac reeducation.
干预措施: HRV measurement (Other)
study strategy
individualization of the rehabilitation program according to the daily HRV measure and the personal functional capacity (measured by a cardiopulmonary test on the program beginning).
干预措施: HRV measurement (Other)
结局指标
主要结局
gain of VO2max
时间窗: after 4 weeks of cardiac rehabilitation
The gain obtained after 4 weeks of cardiac rehabilitation(expressed as% basal value) of VO2max
次要结局
- patients'quality of life after 4 weeks of cardiac rehabilitation(after 4 weeks of cardiac rehabilitation)
- The patient's functional capacity after 4 weeks of cardiac rehabilitation estimated by the distance covered during the 6-minute walk test.(after 4 weeks of cardiac rehabilitation)