Eccentric Manual Resistance Training in Patients With Ischemic CMP

Study Overview
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Brief Summary
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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.

Detailed Description
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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. These patients will be randomized into two groups at the beginning, followed by a 6-weeks observation phase (without intervention for internal quality control of the measurement parameters). The intervention-phase will consist of six weeks of three times weekly either eccentric or concentric-oriented training. Outcome measurements will take place after randomization, after 6 weeks of observation as well as after the intervention phase

Official Title
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Eccentric Manual Resistance Training for Improvement of Strength and Function in Patients With Ischemic Cardiomyopathy and Mildly Reduced Ejection Fraction

Conditions
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Ischemic Cardiomyopathy

Intervention / Treatment
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* Other: Eccentric manual resistance training
* Other: Concentric manual resistance resistance training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male / female, 45-85a Ischemic cardiomyopathy with mildly reduced ejection fraction (40 -50%) Coronary heart disease Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Observation phase<br>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. | |
| Active Comparator: Eccentric training group<br>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 | Other: Eccentric manual resistance training<br>* Eccentric bodyweight resistance training<br>|
| Active Comparator: Concentric training group<br>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 | Other: Concentric manual resistance resistance training<br>* Concentric bodyweight resistance training<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MVC of knee-extensors isometric | Knee dynamometer | Baseline | 
| MVC of knee-extensors isometric | Knee dynamometer | After 6 weeks of observation | 
| MVC of knee-extensors isometric | Knee dynamometer | After 6 weeks of training | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle cross section area of the quadriceps femoris muscle calculated by skeletal muscle ultrasound measurement | Sonographic measurement | Baseline | 
| Muscle cross section area of the quadriceps femoris muscle calculated by skeletal muscle ultrasound measurement | Sonographic measurement | After 6 weeks of observation | 
| Muscle cross section area of the quadriceps femoris muscle calculated by skeletal muscle ultrasound measurement | Sonographic measurement | After 6 weeks of training | 
| Six- minutes walking test (6MWT) | Measures the walking distance within 6 minutes. | Baseline | 
| Six- minutes walking test (6MWT) | Measures the walking distance within 6 minutes. | After 6 weeks of observation | 
| Six- minutes walking test (6MWT) | Measures the walking distance within 6 minutes. | After 6 weeks of training | 
| One-minute sit to stand test | Measures sit to stand repetitions within one minute. | Baseline | 
| One-minute sit to stand test | Measures sit to stand repetitions within one minute. | After 6 weeks of observation | 
| One-minute sit to stand test | Measures sit to stand repetitions within one minute. | After 6 weeks of training | 
| Quality of life (QoL) | Kansas City Cardiomyopathy questionnaire (KCCQ) In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. | Baseline | 
| Quality of life (QoL) | Kansas City Cardiomyopathy questionnaire (KCCQ) In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. | After 6 weeks of observation | 
| Quality of life (QoL): questionnaire | Kansas City Cardiomyopathy questionnaire (KCCQ) In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. | After 6 weeks of training | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eccentric training, Ischemic Cardiomyopathy, Concentric training