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Eccentric Manual Resistance Training in Patients With Ischemic CMP

Primary Purpose

Ischemic Cardiomyopathy

Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Eccentric manual resistance training
Concentric manual resistance resistance training
Sponsored by
Vienna Hospital Association
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Cardiomyopathy focused on measuring Eccentric training, Ischemic Cardiomyopathy, Concentric training

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Klinik OttakringRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

Observation phase

Eccentric training group

Concentric training group

Arm Description

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.

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

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

Outcomes

Primary Outcome Measures

MVC of knee-extensors isometric
Knee dynamometer
MVC of knee-extensors isometric
Knee dynamometer
MVC of knee-extensors isometric
Knee dynamometer

Secondary Outcome Measures

Muscle cross section area of the quadriceps femoris muscle calculated by skeletal muscle ultrasound measurement
Sonographic measurement
Muscle cross section area of the quadriceps femoris muscle calculated by skeletal muscle ultrasound measurement
Sonographic measurement
Muscle cross section area of the quadriceps femoris muscle calculated by skeletal muscle ultrasound measurement
Sonographic measurement
Six- minutes walking test (6MWT)
Measures the walking distance within 6 minutes.
Six- minutes walking test (6MWT)
Measures the walking distance within 6 minutes.
Six- minutes walking test (6MWT)
Measures the walking distance within 6 minutes.
One-minute sit to stand test
Measures sit to stand repetitions within one minute.
One-minute sit to stand test
Measures sit to stand repetitions within one minute.
One-minute sit to stand test
Measures sit to stand repetitions within one minute.
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.
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.
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.

Full Information

First Posted
April 17, 2020
Last Updated
May 12, 2023
Sponsor
Vienna Hospital Association
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1. Study Identification

Unique Protocol Identification Number
NCT04829955
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 29, 2022 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vienna Hospital Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Cardiomyopathy
Keywords
Eccentric training, Ischemic Cardiomyopathy, Concentric training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Observation phase
Arm Type
No Intervention
Arm Description
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.
Arm Title
Eccentric training group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Concentric training group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Eccentric manual resistance training
Intervention Description
Eccentric bodyweight resistance training
Intervention Type
Other
Intervention Name(s)
Concentric manual resistance resistance training
Intervention Description
Concentric bodyweight resistance training
Primary Outcome Measure Information:
Title
MVC of knee-extensors isometric
Description
Knee dynamometer
Time Frame
Baseline
Title
MVC of knee-extensors isometric
Description
Knee dynamometer
Time Frame
After 6 weeks of observation
Title
MVC of knee-extensors isometric
Description
Knee dynamometer
Time Frame
After 6 weeks of training
Secondary Outcome Measure Information:
Title
Muscle cross section area of the quadriceps femoris muscle calculated by skeletal muscle ultrasound measurement
Description
Sonographic measurement
Time Frame
Baseline
Title
Muscle cross section area of the quadriceps femoris muscle calculated by skeletal muscle ultrasound measurement
Description
Sonographic measurement
Time Frame
After 6 weeks of observation
Title
Muscle cross section area of the quadriceps femoris muscle calculated by skeletal muscle ultrasound measurement
Description
Sonographic measurement
Time Frame
After 6 weeks of training
Title
Six- minutes walking test (6MWT)
Description
Measures the walking distance within 6 minutes.
Time Frame
Baseline
Title
Six- minutes walking test (6MWT)
Description
Measures the walking distance within 6 minutes.
Time Frame
After 6 weeks of observation
Title
Six- minutes walking test (6MWT)
Description
Measures the walking distance within 6 minutes.
Time Frame
After 6 weeks of training
Title
One-minute sit to stand test
Description
Measures sit to stand repetitions within one minute.
Time Frame
Baseline
Title
One-minute sit to stand test
Description
Measures sit to stand repetitions within one minute.
Time Frame
After 6 weeks of observation
Title
One-minute sit to stand test
Description
Measures sit to stand repetitions within one minute.
Time Frame
After 6 weeks of training
Title
Quality of life (QoL)
Description
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.
Time Frame
Baseline
Title
Quality of life (QoL)
Description
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.
Time Frame
After 6 weeks of observation
Title
Quality of life (QoL): questionnaire
Description
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.
Time Frame
After 6 weeks of training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Walter Bily, MD
Phone
+43 01 49150
Ext
3404
Email
walter.bily@gesundheitsverbund.at
First Name & Middle Initial & Last Name or Official Title & Degree
Jakob Jauker, MD
Phone
+43 01 49150
Ext
3404
Email
jakob.jauker@gesundheitsverbund.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walter Bily, MD
Organizational Affiliation
Vienna HA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinik Ottakring
City
Vienna
ZIP/Postal Code
1160
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Walter Bily, MD
Phone
+43 01 49150 3404
Email
walter.bily@gesundheitsverbund.at

12. IPD Sharing Statement

Plan to Share IPD
No

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Eccentric Manual Resistance Training in Patients With Ischemic CMP

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