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Completed

NCT Number: NCT04829955

Eccentric Manual Resistance Training in Patients With Ischemic CMP

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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Key information

Age range

45 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinik Ottakring

Vienna, 1160, Austria

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eccentric manual resistance training

Other

Eccentric bodyweight resistance training

Concentric manual resistance resistance training

Other

Concentric bodyweight resistance training

Primary outcomes

  1. MVC of knee-extensors isometric

    Time frame: Baseline

    Knee dynamometer

  2. MVC of knee-extensors isometric

    Time frame: After 6 weeks of observation

    Knee dynamometer

  3. MVC of knee-extensors isometric

    Time frame: After 6 weeks of training

    Knee dynamometer

Secondary outcomes

  1. Muscle cross section area of the quadriceps femoris muscle calculated by skeletal muscle ultrasound measurement

    Time frame: Baseline

    Sonographic measurement

  2. Muscle cross section area of the quadriceps femoris muscle calculated by skeletal muscle ultrasound measurement

    Time frame: After 6 weeks of observation

    Sonographic measurement

  3. Muscle cross section area of the quadriceps femoris muscle calculated by skeletal muscle ultrasound measurement

    Time frame: After 6 weeks of training

    Sonographic measurement

  4. Six- minutes walking test (6MWT)

    Time frame: Baseline

    Measures the walking distance within 6 minutes.

  5. Six- minutes walking test (6MWT)

    Time frame: After 6 weeks of observation

    Measures the walking distance within 6 minutes.

  6. Six- minutes walking test (6MWT)

    Time frame: After 6 weeks of training

    Measures the walking distance within 6 minutes.

  7. One-minute sit to stand test

    Time frame: Baseline

    Measures sit to stand repetitions within one minute.

  8. One-minute sit to stand test

    Time frame: After 6 weeks of observation

    Measures sit to stand repetitions within one minute.

  9. One-minute sit to stand test

    Time frame: After 6 weeks of training

    Measures sit to stand repetitions within one minute.

  10. Quality of life (QoL)

    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.

  11. Quality of life (QoL)

    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.

  12. Quality of life (QoL): questionnaire

    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.

Sponsors and collaborators

Lead sponsor

Vienna Hospital Association

Other Gov

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 2, 2021
Registry last updated
May 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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