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Comparison of the Effects of Different Upper Extremity Aerobic Exercise Training Protocols on Arm Functional Capacity in Patients With Heart Failure With Cardiac Implantable Electronic Devices

29 de julho de 2026 atualizado por: Gamze Nur AHISKALI, Erol Olcok Corum Training and Research Hospital
  1. To determine the most suitable exercise protocol for upper extremity aerobic exercise training, a widely used type of aerobic exercise to improve reduced upper extremity functional capacity in individuals with CIED and HF.
  2. To investigate whether high-intensity intermittent upper extremity aerobic exercise training provides a more effective improvement in upper extremity functional capacity compared to moderate-intensity continuous upper extremity aerobic exercise training.
  3. To determine the effectiveness of different types of upper extremity aerobic exercise training compared to lower extremity aerobic training alone in individuals with CIED and HF.

Visão geral do estudo

Tipo de estudo

Intervencional

Inscrição (Estimado)

36

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.

Locais de estudo

      • Çorum, Turquia (Türkiye)
        • Recrutamento
        • Hitit University Erol Olcok Training and Research Hospital, Cardiac Rehabilitation Unit
        • Contato:

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

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

  • Patients aged 18 and over with heart failure who are receiving Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT)
  • At least 3 months have passed since device implantation and there have been no complications at the last device control
  • Being in New York Heart Association (NYHA) Class II-III
  • Patients without cooperation problems
  • Patients who volunteer to participate in the study

Exclusion Criteria:

  • Patients who have previously participated in a cardiac rehabilitation program and those who have completed less than 1 year since the program,
  • Patients with a primary diagnosis of cardiomyopathy and those with heart failure secondary to cardiomyopathy,
  • Patients with a history of shoulder pathologies that may restrict upper extremity movement before device implantation (such as severe pain around the shoulder, edema, or shoulder dislocation that restricts upper extremity movement),
  • Patients with a history of shoulder surgery (patients with limitations in range of motion),
  • Patients who have undergone mastectomy on the affected side or a cerebrovascular event resulting in arm involvement,
  • Patients with decompensated heart failure,
  • Patients with a history of ICD-incompatible shock,
  • Patients with a history of unstable angina pectoris, acute myocardial infarction, or cardiac surgery within the last 3 months,
  • Patients who have experienced acute atrial fibrillation, ventricular tachycardia, and ventricular fibrillation within the last 3 months,
  • Patients with actively treated malignancy or collagen tissue disease receiving systemic steroids
  • Patients with chronic kidney disease undergoing dialysis where volume load is unstable,
  • Persistent ventricular arrhythmias during baseline cardiopulmonary exercise testing.

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: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: Grupo de controle
a total of 40 minutes, at workloads equivalent to 70-80% of peak oxygen consumption
Experimental: High-Intensity Interval Group
total of 20 minutes, consisting of 5 minutes of warm-up, 3x2 minutes of high-intensity training at 80-90% of maximum workload, 2x2 minutes of active rest at 30-40% of maximum workload, and 5 minutes of cool-down
a total of 40 minutes, at workloads equivalent to 70-80% of peak oxygen consumption
Experimental: Moderate Intensity Continuous Group
a total of 40 minutes, at workloads equivalent to 70-80% of peak oxygen consumption
a total of 20 minutes, consisting of 5 minutes of warm-up, 10 minutes at 70-80% of maximum workload, and 5 minutes of cool-down

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Maximal arm exercise capacity
Prazo: baseline and 8 weeks
The outcome will be evaluated using an arm ergometer exercise test. The test will begin with a 3-minute (unloaded) warm-up after rest. Different protocols will be applied to male and female patients due to differences in strength capabilities. Men will start rotating the ergometer with a 30-W workload, while women will start with a 20-W workload. In both protocols, patients will be asked to maintain a rotation speed of 70 revolutions per minute (rpm) throughout the test. Again, due to their different strength levels, the workload will be increased by 10W for men and 6W for women every minute.
baseline and 8 weeks
Functional arm exercise capacity
Prazo: baseline and 8 weeks
The outcome will be evaluated using the 6 Minute Pegboard and Ring Test (6PBRT). During the 6PBRT, participants are asked to move rings on a pegboard from the two lower holes to the two upper holes using both arms simultaneously for 6 minutes. Standardized encouragement is given every minute during the test. The number of rings moved over 6 minutes gives the total score of the test.
baseline and 8 weeks
Cardiorespiratory Fitness
Prazo: baseline and 8 weeks
The Maximum Symptom-Limited Cardiopulmonary Exercise Test (CPET), the gold standard method for assessing cardiorespiratory fitness, will be performed on a bicycle ergometer (Corival CPET, Lode, Groningen, Netherlands). During the test, the bicycle ergometer ramp test protocol will be applied (starting workload = 20 W / 20W increase every three minutes / maintaining a rotation speed of 60-70 rpm) (2). During the CPET, heart rate (HR) and heart rhythm will be continuously monitored with a 12-channel ECG test system (Custo Cardio 200 BT system, CustoMed GmbH, Ottoburn, Germany).
baseline and 8 weeks

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Peripheral muscle strength
Prazo: baseline and 8 weeks
The outcome will be measured using a hand dynamometer (Baseline Hydraulic Hand Dynamometer, Model: 12-0240, Fabrication Enterprises INC. White Plains, NY 10602 U.S.A.). Measurements will be taken in a seated position with shoulder adduction, elbow 90° flexion, and forearm in neutral position. Three repetitions will be performed for each side. The averages for the right and left sides will be recorded for statistical analysis.
baseline and 8 weeks
Activities of Daily Living
Prazo: baseline and 8 weeks
The outcome will be assessed using the Performance Measure for Activities of Daily Living-8 for Patients with Mild Symptomatic Heart Failure (PMADL-8). PMADL-8, an ICF-based scale, has a total score ranging from 8 to 32, and a high score indicates the level of limitation in activities of daily living.
baseline and 8 weeks
Health-related quality of life
Prazo: baseline and 8 weeks
MacNew Heart Disease Health-Related Quality of Life Questionnaire The questionnaire consists of three sub-dimensions and 27 items: a physical limitation scale, an emotional limitation scale, and a social functioning scale, with some items falling into more than one sub-dimension. Questions are scored between 1 and 7. The total score of the questionnaire is calculated by averaging the scores given to the sub-dimensions. Higher scores indicate better quality of life.
baseline and 8 weeks
Disease-related quality of life
Prazo: baseline and 8 weeks
Assessment of Quality of Life and Related Events Scale (AQUAREL) Developed specifically for patients with pacemakers, the scale consists of 5 main sections: chest pain, arrhythmia, dyspnea, exertion, and cognition. The scale consists of 24 questions scored using a 5-point Likert system. The total score ranges from 0 to 100. A low score reflects a perception of poor health, loss of function, and the presence of pain, while a high score reflects a perception of good health, preserved function, and the absence of pain.
baseline and 8 weeks

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)

11 de maio de 2026

Conclusão Primária (Estimado)

11 de maio de 2027

Conclusão do estudo (Estimado)

11 de maio de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

5 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

11 de maio de 2026

Primeira postagem (Real)

18 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

31 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

29 de julho de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

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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