Ischemic CardiomyopathyNCT04829955
Eccentric Manual Resistance Training in Patients With Ischemic CMP
A study testing Eccentric manual resistance training and Concentric manual resistance resistance training in people with Ischemic Cardiomyopathy, run by Vienna Hospital Association at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Ischemic Cardiomyopathy
- What is being tested?
- Eccentric manual resistance training and Concentric manual resistance resistance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteAustria
- Study dates
- 29 Jun 2022to 12 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male / female, 45-85a
- Ischemic cardiomyopathy with mildly reduced ejection fraction (40 -50%)
- Coronary heart disease
Who cannot join
- 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
Show all 9Show fewer
- Intractable, uncontrolled hypertension (repetitive blood pressure > 150/100)
- Severe comorbidities, which lead to study exclusion by the investigator
- Pregnancy / nursing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Eccentric manual resistance training, Concentric manual resistance resistance training
- Keywords
- Eccentric training, Ischemic Cardiomyopathy, Concentric training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eccentric manual resistance trainingOther
Eccentric bodyweight resistance training
Concentric manual resistance resistance trainingOther
Concentric bodyweight resistance training
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Concentric manual resistance resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
MVC of knee-extensors isometric
Knee dynamometer
Measured: Baseline
MVC of knee-extensors isometric
Knee dynamometer
Measured: After 6 weeks of observation
MVC of knee-extensors isometric
Knee dynamometer
Measured: After 6 weeks of training
Secondary outcomes (12)
Muscle cross section area of the quadriceps femoris muscle calculated by skeletal muscle ultrasound measurement
Sonographic measurement
Measured: Baseline
Muscle cross section area of the quadriceps femoris muscle calculated by skeletal muscle ultrasound measurement
Sonographic measurement
Measured: After 6 weeks of observation
Muscle cross section area of the quadriceps femoris muscle calculated by skeletal muscle ultrasound measurement
Sonographic measurement
Measured: After 6 weeks of training
Six- minutes walking test (6MWT)
Measures the walking distance within 6 minutes.
Measured: Baseline
Six- minutes walking test (6MWT)
Measures the walking distance within 6 minutes.
Measured: After 6 weeks of observation
Six- minutes walking test (6MWT)
Measures the walking distance within 6 minutes.
Measured: After 6 weeks of training
One-minute sit to stand test
Measures sit to stand repetitions within one minute.
Measured: Baseline
One-minute sit to stand test
Measures sit to stand repetitions within one minute.
Measured: After 6 weeks of observation
One-minute sit to stand test
Measures sit to stand repetitions within one minute.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: After 6 weeks of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start29 Jun 2022
- Primary completion12 Dec 2023
- Study completion12 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic CardiomyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vienna Hospital Association
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Walter Bily, MD, Vienna Hospital Association
- Investigators
- Walter Bily, MD, Principal investigator, Vienna HA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04829955
- Sponsor's protocol ID
- Cardio eccentric protocol 3.5
- Status last verified
- Apr 2024
- First submitted
- 17 Apr 2020
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eccentric Manual Resistance Training for Improvement of Strength and Function in Patients With Ischemic Cardiomyopathy and Mildly Reduced Ejection Fraction
- ClinicalTrials.gov ID
- NCT04829955
- Acronym / sponsor ID
- Cardio eccentric protocol 3.5
- Conditions
- Ischemic Cardiomyopathy
- Keywords
- Eccentric training, Ischemic Cardiomyopathy, Concentric training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Vienna Hospital AssociationOther government
- Study start
- 29 Jun 2022 (actual)
- Primary completion
- 12 Dec 2023 (actual)
- Study completion
- 12 Dec 2023 (actual)
- First posted
- 2 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Eccentric manual resistance trainingSubjects 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 |
| Concentric training group | Active comparator | Other: Concentric manual resistance resistance trainingThe 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 |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male / female, 45-85a
- Ischemic cardiomyopathy with mildly reduced ejection fraction (40 -50%)
- Coronary heart disease
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eccentric manual resistance trainingEccentric bodyweight resistance training | Other | Eccentric training group |
| Concentric manual resistance resistance trainingConcentric bodyweight resistance training | Other | Concentric training group |
Primary outcome
MVC of knee-extensors isometric
Time frame: Baseline
Knee dynamometer
MVC of knee-extensors isometric
Time frame: After 6 weeks of observation
Knee dynamometer
MVC of knee-extensors isometric
Time frame: After 6 weeks of training
Knee dynamometer
12 secondary outcomes
Muscle cross section area of the quadriceps femoris muscle calculated by skeletal muscle ultrasound measurement
Time frame: Baseline
Muscle cross section area of the quadriceps femoris muscle calculated by skeletal muscle ultrasound measurement
Time frame: After 6 weeks of observation
Muscle cross section area of the quadriceps femoris muscle calculated by skeletal muscle ultrasound measurement
Time frame: After 6 weeks of training
Six- minutes walking test (6MWT)
Time frame: Baseline
Six- minutes walking test (6MWT)
Time frame: After 6 weeks of observation
Six- minutes walking test (6MWT)
Time frame: After 6 weeks of training
One-minute sit to stand test
Time frame: Baseline
One-minute sit to stand test
Time frame: After 6 weeks of observation
One-minute sit to stand test
Time frame: After 6 weeks of training
Quality of life (QoL)
Time frame: Baseline
Quality of life (QoL)
Time frame: After 6 weeks of observation
Quality of life (QoL): questionnaire
Time frame: After 6 weeks of training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- Individual participant dataSharing planned: No
Related trials for Ischemic Cardiomyopathy
Recruiting
ODSSEY-SCD_Identification Of Markers to preDict the rISk of Sudden Cardiac Death in Moderated LVEF in ischEmic cardiomyopathY
Myocardial Infarction (MI), Sudden Cardiac Death Due to Cardiac Arrhythmia
Not yet recruiting
MRI-guided Ventricular Tachycardia Ablation in Patients With Structural Heart Disease
Ventricular Tachycardia (VT), Ischemic Cardiomyopathy
Not yet recruitingPhase 2
Evaluating SGLT2 Inhibitors for the Reduction of No-Reflow Phenomenon in Patients Undergoing PCI
No Reflow Phenomenon, Reperfusion Injuries, Myocardial
Recruiting
Safety and Effectiveness of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere VT)
Ventricular Tachycardia
Recruiting
Routine Versus Provisional Distal Perfusion Catheter Placement in Patients Undergoing Mechanical Circulatory Support
Cardiogenic Shock, Acute Myocardial Infarction of Inferior Wall
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Walter Bily, MD principal investigator
Vienna HA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eccentric manual resistance training and Concentric manual resistance resistance training in people with Ischemic Cardiomyopathy, run by Vienna Hospital Association at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MVC of knee-extensors isometric (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2024.