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Набор скоро начнётся NCT07447037

Integrating Aerobic, Respiratory, and Cognitive Training in Acute Heart Failure

Без фазы С лечением Acute Heart Failure

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: Aerobic training, Inspiratory muscle training, Cognitive training, Conventional therapy.
Кому может быть актуально
Состояния в реестре: Acute Heart Failure. Базовые параметры: 50 лет — 65 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Египет
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

The purpose of this study is to investigate the impact of integrating aerobic, respiratory and cognitive training in acute heart failure.

Подробное описание

Patients with acute heart failure often experience severe dyspnea, muscle weakness, and cognitive decline during hospitalization, which together impair recovery and increase the risk of rehospitalization. Respiratory muscle dysfunction contributes to exercise intolerance and worsened prognosis, highlighting the importance of targeted inspiratory training. Likewise, immobilization leads to peripheral muscle deconditioning, while cognitive impairment is associated with poor adherence to treatment and lower quality of life.

Pharmacological therapies remain the cornerstone of acute heart failure management; however, they do not directly address these functional and cognitive complications. Consequently, non-pharmacological strategies have gained increasing attention as adjunctive treatments, offering potential benefits without the risks of drug-related side effects.

It is hypothesized that patients with acute heart failure require a multidimensional rehabilitation program that simultaneously supports respiratory, muscular, and cognitive functions. The BLM approach-combining arm ergometer exercise, inspiratory muscle training, and computerized cognitive training-may represent a novel, safe, and effective strategy to accelerate recovery, improve functional outcomes, reduce hospital stay, and potentially lower readmission rates.

Few clinical trials have evaluated such an integrative program in the acute hospital setting. If proven effective, this approach could be incorporated into routine cardiac rehabilitation protocols, providing holistic care that addresses both physical and cognitive dimensions of heart failure.

Вмешательства

  • Другое Aerobic training
    Participants in the experimental group will receive arm ergometer training performed at the bedside for 10-15 minutes, twice daily, at low-to-moderate intensity corresponding to 40-50% of the age-predicted maximum heart rate, under appropriate monitoring. The intervention will be continued throughout the hospitalization period for a minimum duration of three weeks.
  • Другое Inspiratory muscle training
    Participants in the experimental group will receive inspiratory muscle training using a threshold device set at 30% of maximal inspiratory pressure, performed twice daily for 15 minutes per session. The training load will be progressively increased according to patient tolerance, and the intervention will be continued throughout the hospitalization period for a minimum duration of three weeks.
  • Другое Cognitive training
    Participants in the experimental group will receive computerized cognitive training consisting of 20-minute daily sessions targeting attention, memory, and problem-solving abilities. The intervention will be implemented throughout the hospitalization period and will continue for a minimum duration of three weeks.
  • Другое Conventional therapy
    Participants in both groups will receive conventional therapy. The intervention will be implemented throughout the hospitalization period and will continue for a minimum duration of three weeks.

Первичные конечные точки

  • Functional Exercise Capacity [Срок оценки: 3 weeks]
  • Peak Oxygen Consumption [Срок оценки: 3 weeks]
  • Inspiratory Muscle Strength [Срок оценки: 3 weeks]
  • Expiratory Muscle Strength [Срок оценки: 3 weeks]
  • Cognitive Function [Срок оценки: 3 weeks]
Вторичные конечные точки (1)
  • cardiac troponins [Срок оценки: 3 weeks]

Критерии участия

Критерии включения

  • Age between 50-65 years.
  • All patients are male.
  • Diagnosed with acute heart failure according to ESC guidelines.
  • Hemodynamically stable for at least 24 hours.
  • Able to follow simple verbal commands and participate in training.

Критерии исключения

  • Unstable angina or recent myocardial infarction (< 4 weeks).
  • Severe uncontrolled arrhythmias or advanced atrioventricular block.
  • Severe pulmonary disease (e.g., advanced COPD, restrictive lung disease).
  • Neurological disorders causing cognitive or motor disability.
  • Orthopedic or musculoskeletal conditions preventing upper-limb activity.
  • Severe visual or auditory impairment limiting participation in cognitive training.

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
Простое слепое
Основная цель
Лечение

Центры проведения

Египет · 1 центр
  • Cardiology department at El-Kasr El Einy University hospital — Giza

Идентификаторы

NCT: NCT07447037 · P.T.REC/012/006183

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗