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| ID | Type | Description | Link |
|---|---|---|---|
| Belgian Heart Fund | Other Grant/Funding Number | King Baudouin Foundation |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eccentric strength training + cardio | Experimental | 45 sessions experimental protocol |
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| Traditional strength training + cardio | Active Comparator | 45 sessions traditional cardiac rehabilitation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eccentric bike training | Other | progressive following protocol, 10min |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | 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). | 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). | pre (baseline) + post (15weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wendy Hens, PhD | Contact | 0032 3 275 73 89 | wendy.hens@uza.be |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UHAntwerp | Recruiting | Edegem | 2850 | Belgium |
depending on collaboration - if in line with privacy policy this might be done
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 1, 2022 | Dec 1, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 1, 2022 | Dec 1, 2025 | ICF_001.pdf |
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| eccentric overload training | Other | dynamic strength training + eccentric overload, progressive over time, 3sets*10reps (15-20min) |
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| aerobic treadmill training | Other | aerobic training, progressive over time, 10 min |
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| aerobic bike training | Other | aerobic training, progressive following protocol, 10 min |
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| traditional dynamic strength training | Other | dynamic strength training, progression over time, 15-20 min |
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| 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. |
| 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. | pre (baseline) + post (15weeks) |
| 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). | 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. | 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. | 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). | 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. | pre (baseline) + post (15weeks) |