Clinical trial NCT04829955: Eccentric Manual Resistance Training in Patients With Ischemic CMP
Official title: Eccentric Manual Resistance Training for Improvement of Strength and Function in Patients With Ischemic Cardiomyopathy and Mildly Reduced Ejection Fraction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Cardiomyopathy
Keywords: Eccentric training
Ischemic Cardiomyopathy
Concentric training
Lead sponsor: Vienna Hospital Association
Sponsor class: OTHER_GOV
First posted: 2021-04-02
Enrollment: 16
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: MVC of knee-extensors isometric
timeFrame: Baseline
measure: MVC of knee-extensors isometric
timeFrame: After 6 weeks of observation
measure: MVC of knee-extensors isometric
timeFrame: After 6 weeks of training
Secondary outcomes:
measure: Muscle cross section area of the quadriceps femoris muscle calculated by skeletal muscle ultrasound measurement
timeFrame: Baseline
measure: Muscle cross section area of the quadriceps femoris muscle calculated by skeletal muscle ultrasound measurement
timeFrame: After 6 weeks of observation
measure: Muscle cross section area of the quadriceps femoris muscle calculated by skeletal muscle ultrasound measurement
timeFrame: After 6 weeks of training
measure: Six- minutes walking test (6MWT)
timeFrame: Baseline
measure: Six- minutes walking test (6MWT)
timeFrame: After 6 weeks of observation
measure: Six- minutes walking test (6MWT)
timeFrame: After 6 weeks of training
measure: One-minute sit to stand test
timeFrame: Baseline
measure: One-minute sit to stand test
timeFrame: After 6 weeks of observation
measure: One-minute sit to stand test
timeFrame: After 6 weeks of training
measure: Quality of life (QoL)
timeFrame: Baseline
measure: Quality of life (QoL)
timeFrame: After 6 weeks of observation
measure: Quality of life (QoL): questionnaire
timeFrame: After 6 weeks of training
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Klinik Ottakring
Study officials:
affiliation: Vienna HA
name: Walter Bily, MD
role: PRINCIPAL_INVESTIGATOR
References: