- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo 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 julio de 2026 actualizado 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Estimado)
36
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.
Ubicaciones de estudio
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Çorum, Turquía (Türkiye)
- Reclutamiento
- Hitit University Erol Olcok Training and Research Hospital, Cardiac Rehabilitation Unit
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Contacto:
- Gamze Nur Ahiskali
- Número de teléfono: 905514128687
- Correo electrónico: gmzahiskali@gmail.com
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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
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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.
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: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Grupo de control
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Maximal arm exercise capacity
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Peripheral muscle strength
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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)
11 de mayo de 2026
Finalización primaria (Estimado)
11 de mayo de 2027
Finalización del estudio (Estimado)
11 de mayo de 2027
Fechas de registro del estudio
Enviado por primera vez
5 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
11 de mayo de 2026
Publicado por primera vez (Actual)
18 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
31 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
29 de julio de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2026-02
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
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