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Eccentric Muscle Training in Cardiac Rehabilitation

3 de junho de 2026 atualizado 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.

Visão geral do estudo

Descrição detalhada

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 estudo

Intervencional

Inscrição (Estimado)

3

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Wendy Hens, PhD
  • Número de telefone: 0032 3 275 73 89
  • E-mail: wendy.hens@uza.be

Locais de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho
  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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)

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Triplo

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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 Ativo: 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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
1Repetition Maximum (=RM) leg press (kg)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
6mwt (m)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

20 de janeiro de 2023

Conclusão Primária (Estimado)

30 de setembro de 2026

Conclusão do estudo (Estimado)

1 de janeiro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

1 de dezembro de 2025

Enviado pela primeira vez que atendeu aos critérios de CQ

3 de junho de 2026

Primeira postagem (Real)

9 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

9 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

3 de junho de 2026

Última verificação

1 de abril de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Outros números de identificação do estudo

  • EDGE 002632
  • Belgian Heart Fund (Número de outro subsídio/financiamento: King Baudouin Foundation)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

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

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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