Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Eccentric Muscle Training in Cardiac Rehabilitation

3 de junio de 2026 actualizado por: University Hospital, Antwerp

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.

Descripción general del estudio

Descripción detallada

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 de estudio

Intervencionista

Inscripción (Estimado)

3

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Wendy Hens, PhD
  • Número de teléfono: 0032 3 275 73 89
  • Correo electrónico: wendy.hens@uza.be

Ubicaciones de estudio

      • Edegem, Bélgica, 2850
        • Reclutamiento
        • UHAntwerp
        • Contacto:
          • Wendy Hens, PhD
          • Número de teléfono: 0032 3 275 73 89
          • Correo electrónico: wendy.hens@uza.be
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño
  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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)

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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
Comparador activo: 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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
1Repetition Maximum (=RM) leg press (kg)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
6mwt (m)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

20 de enero de 2023

Finalización primaria (Estimado)

30 de septiembre de 2026

Finalización del estudio (Estimado)

1 de enero de 2027

Fechas de registro del estudio

Enviado por primera vez

1 de diciembre de 2025

Primero enviado que cumplió con los criterios de control de calidad

3 de junio de 2026

Publicado por primera vez (Actual)

9 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

9 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

3 de junio de 2026

Última verificación

1 de abril de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Otros números de identificación del estudio

  • EDGE 002632
  • Belgian Heart Fund (Otro número de subvención/financiamiento: King Baudouin Foundation)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

depending on collaboration - if in line with privacy policy this might be done

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Suscribir