Eccentric Manual Resistance Training in Patients With Ischemic CMP

Ischemic Cardiomyopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04829955
• Other study ID #: Cardio eccentric protocol 3.5
• Status: Completed
• Phase: N/A
• Start date: June 29, 2022
• Est. completion date: December 12, 2023

Study information

• Verified date: April 2024
• Source: Vienna Hospital Association
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 12, 2023
• Est. primary completion date: December 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Ischemia
• Ischemic Cardiomyopathy

Intervention

Other:
• Eccentric manual resistance training
Eccentric bodyweight resistance training
• Concentric manual resistance resistance training
Concentric bodyweight resistance training

Locations

Country	Name	City	State
Austria	Klinik Ottakring	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Vienna Hospital Association

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MVC of knee-extensors isometric	Knee dynamometer	Baseline
Primary	MVC of knee-extensors isometric	Knee dynamometer	After 6 weeks of observation
Primary	MVC of knee-extensors isometric	Knee dynamometer	After 6 weeks of training
Secondary	Muscle cross section area of the quadriceps femoris muscle calculated by skeletal muscle ultrasound measurement	Sonographic measurement	Baseline
Secondary	Muscle cross section area of the quadriceps femoris muscle calculated by skeletal muscle ultrasound measurement	Sonographic measurement	After 6 weeks of observation
Secondary	Muscle cross section area of the quadriceps femoris muscle calculated by skeletal muscle ultrasound measurement	Sonographic measurement	After 6 weeks of training
Secondary	Six- minutes walking test (6MWT)	Measures the walking distance within 6 minutes.	Baseline
Secondary	Six- minutes walking test (6MWT)	Measures the walking distance within 6 minutes.	After 6 weeks of observation
Secondary	Six- minutes walking test (6MWT)	Measures the walking distance within 6 minutes.	After 6 weeks of training
Secondary	One-minute sit to stand test	Measures sit to stand repetitions within one minute.	Baseline
Secondary	One-minute sit to stand test	Measures sit to stand repetitions within one minute.	After 6 weeks of observation
Secondary	One-minute sit to stand test	Measures sit to stand repetitions within one minute.	After 6 weeks of training
Secondary	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
Secondary	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
Secondary	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