Strength Training EffectsNCT07636343
Eccentric Muscle Training in Cardiac Rehabilitation
A study testing eccentric bike training, eccentric overload training and aerobic treadmill training in people with Strength Training Effects and HFrEF - Heart Failure With Reduced Ejection Fraction, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Strength Training Effects, HFrEF - Heart Failure With Reduced Ejection Fraction
- What is being tested?
- eccentric bike training, eccentric overload training and aerobic treadmill training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteBelgium
- Study dates
- 20 Jan 2023to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- HFrEF patients with ejection fraction <40%
- Exercise intolerance (<85% of predicted VO2 peak)
- clinically stable for > 6 weeks, optimal medical treatment for > 6 weeks
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
UHAntwerp
Edegem, 2850
Wendy Hens, PhD, 0032 3 275 73 89, wendy.hens@uza.be
wendy.hens@uza.be
About this study
Official title: 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.
Read the 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.
- Being tested
- eccentric bike training, eccentric overload training, aerobic treadmill training, aerobic bike training, traditional dynamic strength training
- Keywords
- eccentric muscle training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eccentric bike trainingOther
progressive following protocol, 10min
eccentric overload trainingOther
dynamic strength training + eccentric overload, progressive over time, 3sets*10reps (15-20min)
aerobic treadmill trainingOther
aerobic training, progressive over time, 10 min
aerobic bike trainingOther
aerobic training, progressive following protocol, 10 min
traditional dynamic strength trainingOther
dynamic strength training, progression over time, 15-20 min
| Study group | Role | What they receive |
|---|---|---|
| Eccentric strength training + cardio | Experimental | 45 sessions experimental protocol Receives: Other: eccentric bike training; Other: eccentric overload training; Other: aerobic treadmill training |
| Traditional strength training + cardio | Active comparator | 45 sessions traditional cardiac rehabilitation Receives: Other: aerobic treadmill training; Other: aerobic bike training; Other: traditional dynamic strength training |
What is being measured
The primary outcome is the main question the study is designed to answer.
1Repetition Maximum (=RM) leg press (kg)
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).
Measured: pre (baseline) + post (15 weeks)
1Repetition Maximum (=RM) Low Row (kg)
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).
Measured: pre (baseline) + post (15weeks)
1Repetition Maximum (=RM) chest press (kg)
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).
Measured: pre (baseline) + post (15weeks)
1Repetition Maximum (=RM) vertical traction (kg)
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).
Measured: pre (baseline) + post (15weeks)
Handgrip strength
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.
Measured: pre (baseline) + post (15 weeks)
Isometric Qceps peak torque (Nm)
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.
Measured: pre (baseline) + post (15weeks)
Secondary outcomes (6)
6mwt (m)
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.
Measured: pre (baseline) - post (15weeks)
Time up and go (s)
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).
Measured: pre (baseline) + post (15weeks)
VO2 peak (ml/kg/min)
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.
Measured: pre (baseline) + post (15weeks)
maximal load (Watt)
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.
Measured: pre (baseline) + post (15weeks)
VO2/W slope (ml/min/W)
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).
Measured: pre (baseline) + post (15weeks)
VE/VCO2 slope
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.
Measured: pre (baseline) + post (15weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start20 Jan 2023
- Primary completion30 Sep 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Strength Training EffectsStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07636343
- Sponsor's protocol ID
- EDGE 002632
- Other IDs
- Belgian Heart Fund
- Status last verified
- Apr 2026
- First submitted
- 1 Dec 2025
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: depending on collaboration - if in line with privacy policy this might be done
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eccentric Muscle Training in Cardiac Rehabilitation: Randomized Controlled Trial to Evaluate Effectiveness and Feasibility in Heart Failure Patients With Reduced Ejection Fraction
- ClinicalTrials.gov ID
- NCT07636343
- Acronym / sponsor ID
- EDGE 002632
- Keywords
- eccentric muscle training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- 20 Jan 2023 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 9 Jun 2026 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eccentric strength training + cardio | Experimental | Other: eccentric bike training, Other: eccentric overload training, Other: aerobic treadmill training45 sessions experimental protocol |
| Traditional strength training + cardio | Active comparator | Other: aerobic treadmill training, Other: aerobic bike training, Other: traditional dynamic strength training45 sessions traditional cardiac rehabilitation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- HFrEF patients with ejection fraction <40%
- Exercise intolerance (<85% of predicted VO2 peak)
- clinically stable for > 6 weeks, optimal medical treatment for > 6 weeks
Key exclusion criteria (5 listed)
- 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)
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 bike trainingprogressive following protocol, 10min | Other | Eccentric strength training + cardio |
| eccentric overload trainingdynamic strength training + eccentric overload, progressive over time, 3sets*10reps (15-20min) | Other | Eccentric strength training + cardio |
| aerobic treadmill trainingaerobic training, progressive over time, 10 min | Other | Eccentric strength training + cardio, Traditional strength training + cardio |
| aerobic bike trainingaerobic training, progressive following protocol, 10 min | Other | Traditional strength training + cardio |
| traditional dynamic strength trainingdynamic strength training, progression over time, 15-20 min | Other | Traditional strength training + cardio |
Primary outcome
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).
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).
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).
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).
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.
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.
6 secondary outcomes
6mwt (m)
Time frame: pre (baseline) - post (15weeks)
Time up and go (s)
Time frame: pre (baseline) + post (15weeks)
VO2 peak (ml/kg/min)
Time frame: pre (baseline) + post (15weeks)
maximal load (Watt)
Time frame: pre (baseline) + post (15weeks)
VO2/W slope (ml/min/W)
Time frame: pre (baseline) + post (15weeks)
VE/VCO2 slope
Time frame: pre (baseline) + post (15weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: No. depending on collaboration - if in line with privacy policy this might be done
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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.
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 bike training, eccentric overload training and aerobic treadmill training in people with Strength Training Effects and HFrEF - Heart Failure With Reduced Ejection Fraction, run by University Hospital, Antwerp at 1 site in Belgium.
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 5 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: looking for participants now, as of the sponsor's last update on 9 Jun 2026. 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 Belgium. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wendy Hens, PhD (0032 3 275 73 89, wendy.hens@uza.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1Repetition Maximum (=RM) leg press (kg) (time frame: pre (baseline) + post (15 weeks)). The study lists 6 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 9 Jun 2026.