- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07636343
Eccentric Muscle Training in Cardiac Rehabilitation
Eccentric Muscle Training in Cardiac Rehabilitation: Randomized Controlled Trial to Evaluate Effectiveness and Feasibility in Heart Failure Patients With Reduced Ejection Fraction
The goal of this interventional study is to assess the training effects in a training schedule in which eccentric overload training and eccentric cycle training are used.
Researchers will compare a training program of eccentric overload training and eccentric cycling training with a traditional training program of strength and cardio training in people with heart failure with reduced ejection fraction.
This study will be delivered in a cardiac rehabilitation setting.
Study Overview
Status
Detailed Description
Patients with HFrEF experience in general more difficulties completing exercise training trajectory because of low physical fitness and multiple comorbidies.
In this study traditional exercise capacity outcomes are assessed eg. endurance capacity, muscle strength and muscle mass in patients with HFrEF.
It is hypothesized that greater muscle strength and muscle mass are obtained by eccentric muscle training in comparison with conventional training because higher training volumes can be used with a lower metabolic demand.
Possibly, a better outcome regarding muscle function and mass will influence VO2 peak and functionality in this patient population.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Wendy Hens, PhD
- Phone Number: 0032 3 275 73 89
- Email: wendy.hens@uza.be
Study Locations
-
-
-
Edegem, Belgium, 2850
- Recruiting
- UHAntwerp
-
Contact:
- Wendy Hens, PhD
- Phone Number: 0032 3 275 73 89
- Email: wendy.hens@uza.be
-
Contact:
- Email: wendy.hens@uza.be
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- HFrEF patients with ejection fraction <40%
- Exercise intolerance (<85% of predicted VO2 peak)
- clinically stable for > 6 weeks, optimal medical treatment for > 6 weeks
Exclusion Criteria:
- Contra indications for cardiac exercise rehabilitation as per consensus guidelines and recommendations
- Musculoskeletal disorders that hamper (progression in) strength training
- Non-stabilized acute coronary syndrome
- Current acute heart failure (decompensation)
- Patient having sustained a recent (<3 months) procedure that could act as a confounder to increase VO2peak (i.e., coronary artery bypass graft surgery, percutaneous coronary intervention, cardiac resynchronization therapy, valve surgery or reparation)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Eccentric strength training + cardio
45 sessions experimental protocol
|
progressive following protocol, 10min
dynamic strength training + eccentric overload, progressive over time, 3sets*10reps (15-20min)
aerobic training, progressive over time, 10 min
|
|
Active Comparator: Traditional strength training + cardio
45 sessions traditional cardiac rehabilitation
|
aerobic training, progressive over time, 10 min
aerobic training, progressive following protocol, 10 min
dynamic strength training, progression over time, 15-20 min
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
1Repetition Maximum (=RM) leg press (kg)
Time Frame: pre (baseline) + post (15 weeks)
|
One repetition maximum on leg press device Technogym BioCircuit. The patient is positioned correctly on the leg press (back supported, feet on platform in standardized way so that repeated tests are in the same position). The patiënt performes a maximal push, the load is automatically adjusted by the BioCircuit algorithm. The system identifies the maximum successful single push as the 1RM (kg). |
pre (baseline) + post (15 weeks)
|
|
1Repetition Maximum (=RM) Low Row (kg)
Time Frame: pre (baseline) + post (15weeks)
|
One repetition maximum on the low row device Technogym BioCircuit. The patient sits with chest supported, feet on the ground, and grips the handles with arms extended. The patiënt performes a maximal pull, the load is automatically adjusted by the BioCircuit algorithm. The system identifies the maximum successful single lift as the 1RM (kg). |
pre (baseline) + post (15weeks)
|
|
1Repetition Maximum (=RM) chest press (kg)
Time Frame: pre (baseline) + post (15weeks)
|
One repetition maximum on chest press device Technogym BioCircuit.
The patient is positioned correctly on the chest press (back supported, feet on the ground in standardized way so that repeated tests are in the same position).
The patiënt performes a maximal push, the load is automatically adjusted by the BioCircuit algorithm.
The system identifies the maximum successful single push as the 1RM (kg).
|
pre (baseline) + post (15weeks)
|
|
1Repetition Maximum (=RM) vertical traction (kg)
Time Frame: pre (baseline) + post (15weeks)
|
One repetition maximum on vertical traction device Technogym BioCircuit. The patient is positioned correctly on the vertical traction (back supported, feet on the ground in standardized way so that repeated tests are in the same position). The patiënt performes a maximal pull, the load is automatically adjusted by the BioCircuit algorithm. The system identifies the maximum successful single push as the 1RM (kg). |
pre (baseline) + post (15weeks)
|
|
Handgrip strength
Time Frame: pre (baseline) + post (15 weeks)
|
The Jamar handgrip dynamometer is used to measure grip strength in a standardized way ( 90° flex elbow, forearm neutral, and wrist slightly extended). 3 trials per hand are performed, with 10seconds rest in between. The average value is recorded as grip strength. |
pre (baseline) + post (15 weeks)
|
|
Isometric Qceps peak torque (Nm)
Time Frame: pre (baseline) + post (15weeks)
|
The subject is seated in the Biodex System dynamometer and securely strapped (trunk, pelvis, thigh). The dynamometer axis is aligned with the knee joint axis (lateral femoral epicondyle). The knee is fixed at 60° of flexion (0° = full extension). The lower leg is attached to the lever arm just above the ankle. The subject performs a maximal isometric knee extension (pushing against the immovable arm) for 3seconds. 3 tests are done with 10seconds rest in between. The highest torque value (Nm) recorded is taken as the quadriceps peak torque. |
pre (baseline) + post (15weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
6mwt (m)
Time Frame: pre (baseline) - post (15weeks)
|
The 6-minute walk test (6MWT) assesses functional exercise capacity by measuring the distance walked in 6 minutes. It is performed on the same flat, straight corridor (50 meter) with marked turnaround points. The participant is instructed to walk as fast as possible at a self-paced speed. Standardized encouragement is given every minute. A timer is started at the beginning and stopped at 6 minutes. The total distance walked is measured in meters. |
pre (baseline) - post (15weeks)
|
|
Time up and go (s)
Time Frame: pre (baseline) + post (15weeks)
|
The participant starts seated in a standard chair (back against the chair, no armrests) On the command "go," the participant stands up, walks 3 meters, turns around, walks back, and sits down again. Timing starts on "go" and stops when the participant is seated again with the back against the chair). The test is performed 3 times (with 20seconds rest in between). The outcome is the mean time taken to complete the 3 tasks (seconds). |
pre (baseline) + post (15weeks)
|
|
VO2 peak (ml/kg/min)
Time Frame: pre (baseline) + post (15weeks)
|
VO₂peak is measured during a cardiopulmonary exercise test (CPET) on a cycle ergometer. The test is performed on a Lode Corival ergometer with breath-by-breath gas analysis via a Vyaire Medical system. After calibration of flow and gas analyzers, the subject is fitted with a mask and monitoring devices (ECG, BP). A short resting phase and unloaded cycling (warm-up) are performed. Workload then increases continuously using an individualized ramp protocol (e.g. 5-20 Watt/min - so small increase every 3-12 seconds). The same protocol is used in the pre and post test. The participant cycles at a constant cadence(≈60-70 revolutions/min) until volitional exhaustion. Expired gases are analyzed to determine oxygen uptake (VO₂) and carbon dioxide production (VCO₂). Strong verbal encouragement is given to reach maximal effort. VO₂peak is defined as the mean VO₂ value averaged over the final 30 seconds of exercise. Test termination follows symptom limitation or standard clinical safety criteria. |
pre (baseline) + post (15weeks)
|
|
maximal load (Watt)
Time Frame: pre (baseline) + post (15weeks)
|
Wattmax is determined during a CPET performed on a Lode Corival ergometer with monitoring via a Vyaire Medical system. After calibration of flow and gas analyzers, the subject is fitted with a mask and monitoring devices (ECG, BP). A short resting phase and unloaded cycling (warm-up) are performed. Workload then increases continuously using an individualized ramp protocol (e.g. 5-20 Watt/min - so small increase every 3-12 seconds). The same protocol is used in the pre and post test. The participant cycles at a constant cadence (≈60-70 revolutions/min) until volitional exhaustion. Wattmax is defined as the highest workload (in watts) achieved in the final stage. Strong encouragement is provided to achieve maximal effort. |
pre (baseline) + post (15weeks)
|
|
VO2/W slope (ml/min/W)
Time Frame: pre (baseline) + post (15weeks)
|
VO2/W slope is measured during a cardiopulmonary exercise test (CPET) on a cycle ergometer. The test is performed on a Lode Corival ergometer with breath-by-breath gas analysis via a Vyaire Medical system. After calibration of flow and gas analyzers, the subject is fitted with a mask and monitoring devices (ECG, BP). A short resting phase and unloaded cycling (warm-up) are performed. Workload then increases continuously using an individualized ramp protocol (e.g. 5-20 Watt/min - so small increase every 3-12 seconds). The same protocol is used in the pre and post test. The participant cycles at a constant cadence (≈60-70 revolutions/min) until volitional exhaustion. The relationship between VO₂ (y-axis) and work rate (x-axis) is plotted. A linear regression is applied. The slope of this line represents the VO₂/W slope (mL/min/W). |
pre (baseline) + post (15weeks)
|
|
VE/VCO2 slope
Time Frame: pre (baseline) + post (15weeks)
|
The VE/VCO₂ slope is measured during CPET on a Lode Corival ergometer with breath-by-breath analysis via Vyaire Medical. After calibration of flow and gas analyzers, the subject is fitted with a mask and monitoring devices (ECG, BP). A short resting phase and unloaded cycling (warm-up) are performed. Workload then increases continuously using an individualized ramp protocol (e.g. 5-20 Watt/min - so small increase every 3-12 seconds). The same protocol is used in the pre and post test. The participant cycles at a constant cadence (≈60-70 revolutions/min) until volitional exhaustion. VE is plotted against VCO₂ over the course of exercise. A linear regression is applied from the start of exercise up to the ventilatory compensation point. The slope of this relationship represents the VE/VCO₂ slope. |
pre (baseline) + post (15weeks)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- EDGE 002632
- Belgian Heart Fund (Other Grant/Funding Number: King Baudouin Foundation)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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