- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07592494
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
- 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.
- 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.
- 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
Status
Recrutamento
Condições
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
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Çorum, Turquia (Türkiye)
- Recrutamento
- Hitit University Erol Olcok Training and Research Hospital, Cardiac Rehabilitation Unit
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Contato:
- Gamze Nur Ahiskali
- Número de telefone: 905514128687
- E-mail: gmzahiskali@gmail.com
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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 |
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Comparador Ativo: Grupo de controle
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a total of 40 minutes, at workloads equivalent to 70-80% of peak oxygen consumption
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Experimental: High-Intensity Interval Group
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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
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Experimental: Moderate Intensity Continuous Group
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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
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Maximal arm exercise capacity
Prazo: baseline and 8 weeks
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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.
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baseline and 8 weeks
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Functional arm exercise capacity
Prazo: baseline and 8 weeks
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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.
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baseline and 8 weeks
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Cardiorespiratory Fitness
Prazo: baseline and 8 weeks
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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).
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baseline and 8 weeks
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Peripheral muscle strength
Prazo: baseline and 8 weeks
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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.
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baseline and 8 weeks
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Activities of Daily Living
Prazo: baseline and 8 weeks
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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.
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baseline and 8 weeks
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Health-related quality of life
Prazo: baseline and 8 weeks
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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.
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baseline and 8 weeks
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Disease-related quality of life
Prazo: baseline and 8 weeks
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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.
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baseline and 8 weeks
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
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
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2026-02
Informações sobre medicamentos e dispositivos, documentos de estudo
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Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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