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Набор скоро начнётся NCT07144722

Prehabilitation Program for Patients Awaiting Elective Heart Surgery at Increased Risk of Postoperative Complications: Feasibility and Potential Clinical Outcomes

Без фазы С лечением Cardiac Surgery Prehabilitation Postoperative Complications

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: Exercise.
Кому может быть актуально
Состояния в реестре: Cardiac Surgery, Prehabilitation, Postoperative Complications. 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
Канада
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Preliminary Evaluation of a Prehabilitation Program for Adults Awaiting Elective Heart Surgery and at Increased Risk of Postoperative Complications

Обзор

The goal of this study is to learn if an exercise-based prehabilitation program can help people who are waiting for heart surgery and are at higher risk of complications recover better. The main questions it aims to answer are: Can a home-based prehabilitation program prescribed by a physiotherapist be done safely and realistically before heart surgery? Participants will: Take part in a personalized exercise program for a 8 to 16 weeks before surgery Do breathing muscle training at home Meet with a physiotherapist once a week, either in person or by video call Be assessed before and after the program Researchers will compare the postoperative results with those of patients who received usual care only.

Вмешательства

  • Другое Exercise
    What distinguishes this intervention from others is its hybrid delivery model, combining virtual more than in-person sessions to increase accessibility and adherence. Additionally, it incorporates specific inspiratory muscle training, which is often overlooked in standard prehabilitation programs, and emphasizes a personalized progression based on each participant's functional capacity and feedback. This tailored approach aims to optimize physical readiness before surgery while minimizing patien

Первичные конечные точки

  • Recruitment Rate (%) [Срок оценки: From enrollment to the end of treatment at maximum 16 weeks]
  • Adherence Rate (%) [Срок оценки: From enrollment to the end of treatment at maximum 16 weeks]
  • Program Safety - number of participants experiencing exercise-related adverse events [Срок оценки: From enrollment to the end of treatment at maximum 16 weeks]
  • Participant Satisfaction - likelihood to recommend [Срок оценки: From enrollment to the end of treatment at maximum 16 weeks]
  • Participant Satisfaction - likelihood to repeat [Срок оценки: From enrollment to the end of treatment at maximum 16 weeks]
Вторичные конечные точки (11)
  • Maximal Inspiratory Pressure (cmH2O) [Срок оценки: From enrollment to the end of treatment at maximum 16 weeks]
  • Diaphragm Thickening Fraction (%) [Срок оценки: From enrollment to the end of treatment at maximum 16 weeks]
  • Grip Strength (kg) [Срок оценки: From enrollment to the end of treatment at maximum 16 weeks]
  • 5-repetition-sit-to-stand Test - Lower Limb Strength (seconds) [Срок оценки: From enrollment to the end of treatment at maximum 16 weeks]
  • 5-meter Gait Speed (seconds) [Срок оценки: From enrollment to the end of treatment at maximum 16 weeks]
  • Functional Capacity - six-minute walk distance (meters) [Срок оценки: From enrollment to the end of treatment at maximum 16 weeks]
  • Number of participants with postoperative pulmonary complications [Срок оценки: From the day of surgery through hospital discharge (average of 10 days)]
  • Duration of postoperative mechanical ventilation (hours) [Срок оценки: From ICU admission after surgery until extubation (within hospital stay, average 24-72 hours)]
  • Recovery of Mobility - Postoperative day of first mobilization (day out of bed) [Срок оценки: Un average of 1 - 3 days]
  • Recovery of Mobility - Postoperative day of first ambulation [Срок оценки: An average of 3 - 6 days]
  • Length of Postoperative Hospital Stay (days) [Срок оценки: From the day of surgery through hospital discharge (average of 10 days)]

Критерии участия

Критерии включения

  • A high risk of perioperative and postoperative complications. This risk is determined based on the predictive thresholds for postoperative complications.
  • A waiting period of at least 8 weeks.
  • Access to a smartphone, tablet, or computer for videoconference visits.

Критерии исключения

  • Unstable angina, malignant arrhythmias, active endocarditis/myocarditis, myocardial infarction within the last 2 weeks, left main coronary artery disease ≥ 50% on coronary angiography, severe aortic stenosis, severe mitral insufficiency, and decompensated heart failure.
  • Any other acute condition affecting vital signs or causing significant symptoms.
  • Physical or cognitive impairment limiting the ability to participate in the program.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Канада · 1 центр
  • Montreal Heart Institut — Montreal

Идентификаторы

NCT: NCT07144722 · 2025-3527

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗