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Идёт набор 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

Без фазы С лечением Heart Failure Implantable Cardioverter Defibrillator (ICD) Cardiac Resynchronization Therapy Devices

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: High-Intensity Interval Upper Extremity Aerobic Exercise Training, Moderate Intensity Continuous Upper Extremity Aerobic Exercise Training, Lower Extremity Aerobic Exercise Training.
Кому может быть актуально
Состояния в реестре: Heart Failure, Implantable Cardioverter Defibrillator (ICD), Cardiac Resynchronization Therapy Devices. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
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Обзор

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.

Вмешательства

  • Другое High-Intensity Interval Upper Extremity Aerobic Exercise Training
    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
  • Другое Moderate Intensity Continuous Upper Extremity Aerobic Exercise Training
    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
  • Другое Lower Extremity Aerobic Exercise Training
    a total of 40 minutes, at workloads equivalent to 70-80% of peak oxygen consumption

Первичные конечные точки

  • Maximal arm exercise capacity [Срок оценки: baseline and 8 weeks]
  • Functional arm exercise capacity [Срок оценки: baseline and 8 weeks]
  • Cardiorespiratory Fitness [Срок оценки: baseline and 8 weeks]
Вторичные конечные точки (4)
  • Peripheral muscle strength [Срок оценки: baseline and 8 weeks]
  • Activities of Daily Living [Срок оценки: baseline and 8 weeks]
  • Health-related quality of life [Срок оценки: baseline and 8 weeks]
  • Disease-related quality of life [Срок оценки: baseline and 8 weeks]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Turkey (Türkiye) · 1 центр
  • Hitit University Erol Olcok Training and Research Hospital, Cardiac Rehabilitation Unit — Çorum

Идентификаторы

NCT: NCT07592494 · 2026-02

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗