Eccentric Manual Resistance Training in Patients With Ischemic CMP

NCT ID: NCT04829955

Last Updated: 2024-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-29
• Study Completion Date: 2023-12-12

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

Conditions

Ischemic Cardiomyopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: ACTIVE_COMPARATOR

Eccentric manual resistance training

Intervention Type: OTHER

Eccentric bodyweight resistance training

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

Group Type: ACTIVE_COMPARATOR

Concentric manual resistance resistance training

Intervention Type: OTHER

Concentric bodyweight resistance training

Interventions

Eccentric manual resistance training

Eccentric bodyweight resistance training

Intervention Type: OTHER

Concentric manual resistance resistance training

Concentric bodyweight resistance training

Intervention Type: OTHER

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vienna Hospital Association

OTHER_GOV

Sponsor Role: lead

Responsible Party

Walter Bily, MD

Representative Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Walter Bily, MD

Role: PRINCIPAL_INVESTIGATOR

Vienna HA

Locations

Klinik Ottakring

Vienna, , Austria

Countries

Austria

Other Identifiers

Cardio eccentric protocol 3.5

Identifier Type: -

Identifier Source: org_study_id