Eccentric Manual Resistance Training for Improvement of Strength and Function in Patients With Ischemic Cardiomyopathy and Mildly Reduced Ejection Fraction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- MVC of knee-extensors isometric
研究概览
简要总结
Patients with ischemic cardiomyopathy and mildly reduced ejection fraction suffer from reduced functional capacity and fatigue caused by loss of muscle strength and reduced aerobic capacity.
A few studies have shown that structured endurance and resistance training programs were able to improve walking capacity and limb strength.
Although both concentric and eccentric training programs are beneficial for these patients, eccentric training is less stressful to the cardiovascular system.
The aim of the study is to determine if eccentric-orientated body weight and manual resistance training in ischemic cardiomyopathy patients will lead to superior results compared to concentric training.
详细描述
BACKGROUND: Eccentric resistance training demonstrated positive effects in ischemic cardiomyopathy patients in several studies. These studies were mainly set on device-based training interventions comparing eccentric-orientated and concentric-orientated training. Eccentric-orientated training induced comparable positive effects on cardiac and functional levels and even better effects on muscle strength improvement.
RESEARCH AIMS: The aim of the study is to determine if eccentric-orientated body weight and manual resistance training in ischemic cardiomyopathy patients will allow a more significant improvement in maximum voluntary contraction force of the knee extensors compared to concentric training.
In contrast to previous studies, these interventions will be set without use of training devices.
In addition, changes in the muscle cross section of the quadriceps muscle will be calculated by skeletal muscle ultrasound. Functional changes and quality of life will be assessed using one minute sit to stand test, six minutes walking test and Kansas City Cardiomyopathy Questionnaire. Cardiac outcome parameters will be assessed by using body composition and hemodynamic parameters as well as echocardiography, laboratory values and specific biomarkers for sarcopenia / cachexia.
METHODS: The investigators propose to run a monocentric, prospective, double arm, open, randomized controlled trial. Eccentric-orientated training will be delivered to 30 ischemic cardiomyopathy patients.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male / female, 45-85a
- •Ischemic cardiomyopathy with mildly reduced ejection fraction (40 -50%)
- •Coronary heart disease
排除标准
- •Acute coronary syndrome, myocarditis or pericarditis in the last 3 months
- •Cardiac decompensation in the last 3 months
- •Severe symptomatic heart failure NYHA IV (New York Heart Association)
- •Device - carrier (ICD= Intracardial Defibrillator, CRT= Cardiac Resynchronization Therapy, PM=Pacemaker)
- •Hemodynamically significant valvular disease
- •Symptomatic cardiac arrhythmia
- •Intractable, uncontrolled hypertension (repetitive blood pressure > 150/100)
- •Severe comorbidities, which lead to study exclusion by the investigator
- •Pregnancy / nursing
研究组 & 干预措施
Observation phase
After screening and randomization for either the eccentric orientated intervention group or the concentric orientated intervention group, all measurements will be made for the first time by investigators at point A1. An observational phase for six weeks will follow to achieve an intern acceptance sampling for the measurements which will be used.
Eccentric training group
Subjects in the eccentric training group (GEC) will attend six weeks of eccentric orientated training. The eccentric orientated training will use the cadence 3-0-1 for eccentric - break - concentric.
- 3 sessions/week
- 60 minutes per session including a warming up and cool down phase
- 6 exercises
- total of 18 sessions
干预措施: Eccentric manual resistance training (Other)
Concentric training group
The concentric training group (GCO) will attend six weeks of concentric orientated training. Each group will perform a manual resistance/bodyweight resistance training accentuating the concentric phase of the movement. The concentric orientated training will use the cadence 1-0-3 for eccentric - break - concentric.
- 3 sessions/week
- 60 minutes per session including a warming up and cool down phase
- 6 exercises
- total of 18 sessions
干预措施: Concentric manual resistance resistance training (Other)
结局指标
主要结局
MVC of knee-extensors isometric
时间窗: After 6 weeks of training
Knee dynamometer
MVC of knee-extensors isometric
时间窗: Baseline
Knee dynamometer
MVC of knee-extensors isometric
时间窗: After 6 weeks of observation
Knee dynamometer
次要结局
- Muscle cross section area of the quadriceps femoris muscle calculated by skeletal muscle ultrasound measurement(After 6 weeks of training)
- Six- minutes walking test (6MWT)(After 6 weeks of training)
- One-minute sit to stand test(After 6 weeks of training)
- Quality of life (QoL)(After 6 weeks of observation)
- Quality of life (QoL): questionnaire(After 6 weeks of training)
- Muscle cross section area of the quadriceps femoris muscle calculated by skeletal muscle ultrasound measurement(Baseline)
- Muscle cross section area of the quadriceps femoris muscle calculated by skeletal muscle ultrasound measurement(After 6 weeks of observation)
- Six- minutes walking test (6MWT)(Baseline)
- Six- minutes walking test (6MWT)(After 6 weeks of observation)
- One-minute sit to stand test(Baseline)
- One-minute sit to stand test(After 6 weeks of observation)
- Quality of life (QoL)(Baseline)
研究者
Walter Bily, MD
Representative Director
Vienna Hospital Association