Eccentric Manual Resistance Training in Patients With Ischemic CMP

NCT04829955 | Completed DMC

• 1 other identifier: Cardio eccentric protocol 3.5
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Cardiomyopathy

Keywords

Eccentric training; Ischemic Cardiomyopathy; Concentric training

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (12)

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

  Baseline

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

  After 6 weeks of observation

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

  After 6 weeks of training

• Six- minutes walking test (6MWT)

  Baseline

• Six- minutes walking test (6MWT)

  After 6 weeks of observation

Study Arms (3)

Observation phase

NO INTERVENTION

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.

Eccentric training group

ACTIVE COMPARATOR

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

Concentric training group

ACTIVE COMPARATOR

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

Interventions

Eccentric manual resistance training OTHER

Eccentric bodyweight resistance training

Eccentric training group

Concentric manual resistance resistance training OTHER

Concentric bodyweight resistance training

Concentric training group

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male / female, 45-85a
• Ischemic cardiomyopathy with mildly reduced ejection fraction (40 -50%)
• Coronary heart disease

You may not qualify if:

• 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)
• Pregnancy / nursing

Sponsors & Collaborators

• Vienna Hospital Association: lead

Study Sites (1)

Klinik Ottakring

Vienna, 1160, Austria

Location

Study Officials

• Walter Bily, MD

  Vienna HA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Representative Director

Study Record Dates

• First Submitted: April 17, 2020
• First Posted: April 2, 2021
• Study Start: June 29, 2022
• Primary Completion: December 12, 2023
• Study Completion: December 12, 2023
• Last Updated: May 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)