Eccentric Manual Resistance Training in Patients With Ischemic CMP

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

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.

Study Overview

• Status: Completed
• Conditions: Ischemic Cardiomyopathy
• Intervention / Treatment: Other: Eccentric manual resistance training; Other: Concentric manual resistance resistance 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

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1160
    • Klinik Ottakring

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Active Comparator: 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	Other: Eccentric manual resistance training; Eccentric bodyweight resistance training
Active Comparator: 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	Other: Concentric manual resistance resistance training; Concentric bodyweight resistance training

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Vienna Hospital Association
• Investigators: Principal Investigator: Walter Bily, MD, Vienna HA

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2022
• Primary Completion (Actual): December 12, 2023
• Study Completion (Actual): December 12, 2023

Study Registration Dates

• First Submitted: April 17, 2020
• First Submitted That Met QC Criteria: March 31, 2021
• First Posted (Actual): April 2, 2021

Study Record Updates

• Last Update Posted (Actual): May 1, 2024
• Last Update Submitted That Met QC Criteria: April 30, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Ischemic Cardiomyopathy; Eccentric training; Concentric training
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Ischemia; Cardiomyopathies
• Other Study ID Numbers: Cardio eccentric protocol 3.5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No