- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Wendy Hens, PhD
- Numero di telefono: 0032 3 275 73 89
- Email: wendy.hens@uza.be
Luoghi di studio
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Edegem, Belgio, 2850
- Reclutamento
- UHAntwerp
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Contatto:
- Wendy Hens, PhD
- Numero di telefono: 0032 3 275 73 89
- Email: wendy.hens@uza.be
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Contatto:
- Email: wendy.hens@uza.be
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Eccentric strength training + cardio
45 sessions experimental protocol
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progressive following protocol, 10min
dynamic strength training + eccentric overload, progressive over time, 3sets*10reps (15-20min)
aerobic training, progressive over time, 10 min
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Comparatore attivo: Traditional strength training + cardio
45 sessions traditional cardiac rehabilitation
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aerobic training, progressive over time, 10 min
aerobic training, progressive following protocol, 10 min
dynamic strength training, progression over time, 15-20 min
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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1Repetition Maximum (=RM) leg press (kg)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
6mwt (m)
Lasso di tempo: 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)
|
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Time up and go (s)
Lasso di tempo: 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)
|
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VO2 peak (ml/kg/min)
Lasso di tempo: 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)
|
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maximal load (Watt)
Lasso di tempo: 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)
Lasso di tempo: 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)
|
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VE/VCO2 slope
Lasso di tempo: 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)
|
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Primo inviato che soddisfa i criteri di controllo qualità
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Ultimo aggiornamento pubblicato (Effettivo)
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Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- EDGE 002632
- Belgian Heart Fund (Altro numero di sovvenzione/finanziamento: King Baudouin Foundation)
Piano per i dati dei singoli partecipanti (IPD)
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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