Klinik Ottakring
Vienna, 1160, Austria
NCT Number: NCT04829955
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.
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Notify Me45 year–85 year
All sexes
Interventional
Not applicable
Vienna, 1160, Austria
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Eccentric bodyweight resistance training
Concentric bodyweight resistance training
Time frame: Baseline
Knee dynamometer
Time frame: After 6 weeks of observation
Knee dynamometer
Time frame: After 6 weeks of training
Knee dynamometer
Time frame: Baseline
Sonographic measurement
Time frame: After 6 weeks of observation
Sonographic measurement
Time frame: After 6 weeks of training
Sonographic measurement
Time frame: Baseline
Measures the walking distance within 6 minutes.
Time frame: After 6 weeks of observation
Measures the walking distance within 6 minutes.
Time frame: After 6 weeks of training
Measures the walking distance within 6 minutes.
Time frame: Baseline
Measures sit to stand repetitions within one minute.
Time frame: After 6 weeks of observation
Measures sit to stand repetitions within one minute.
Time frame: After 6 weeks of training
Measures sit to stand repetitions within one minute.
Time frame: Baseline
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.
Time frame: After 6 weeks of observation
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.
Time frame: After 6 weeks of training
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.
Vienna Hospital Association
Other Gov
Eccentric Manual Resistance Training for Improvement of Strength and Function in Patients With Ischemic Cardiomyopathy and Mildly Reduced Ejection Fraction
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