Набор скоро начнётся NCT07350941

Impact of Cardiac Rehabilitation Adapted for Patients With Heart Failure

Без фазы С лечением 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: Cardiac rehabilitation program.
Кому может быть актуально: Состояния в реестре: Heart Failure. Базовые параметры: от 65 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: Испания
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

RAP-IC Study: Impact of Cardiac Rehabilitation Adapted for Patients With Heart Failure

Обзор

The aim of the study is to evaluate whether a tailored cardiac rehabilitation program, initiated during hospitalization and continued after discharge, can improve functional capacity, mobility, and quality of life in patients over 65 years old with heart failure.

Подробное описание

If you meet the inclusion criteria and wish to participate, an initial assessment of your clinical and functional status will be conducted during your hospital stay. A computer system will then randomly assign you to one of the following groups:

Cardiac Rehabilitation Group (treatment group): You will participate in a mild exercise program during hospitalization (Phase I), including mobility and respiratory exercises adapted to your clinical condition. After discharge, you will enter a structured in-person cardiac rehabilitation program (Phase II) lasting 3 months, consisting of two 1-hour exercise sessions per week (aerobic, strength, inspiratory, and proprioceptive exercises) plus one weekly educational session.

Usual Care Group (control group): You will receive standard recommendations for physical activity and general care.

At the end of the study, a final consultation will be conducted to assess differences between the two groups in functional capacity and quality of life.

Вмешательства

Другое Cardiac rehabilitation program
Cardiac rehabilitation program, in which patients will attend in person twice weekly (Mondays and Wednesdays or Tuesdays and Thursdays), in groups of up to 8 patients, for 1-hour exercise sessions including aerobic, resistance, respiratory, and balance/proprioceptive components. Sessions will be monitored and supervised by cardiologists, rehabilitation physicians, and physiotherapists. In addition, patients will attend one weekly in-person educational session throughout the 3-month program.

Первичные конечные точки

Primary Endpoint: Change in Peak Oxygen Uptake [Срок оценки: 3 months]

Вторичные конечные точки (12)

Change in Functional Permormance assessed by the Short Physical Performance Battery (SPPB) score [Срок оценки: 3 months]
Change in the Kansas City Cardiomyopathy Questionnaire-23 (KCCQ-23) score [Срок оценки: 3 and 6 months]
Change in distance walked (meters) in the 6-Minute Walk Test (6MWT). [Срок оценки: 3 and 6 months]
Change in caregiver burden assessed by the Zarit scale [Срок оценки: 3 and 6 months]
Change in body composition parameters assessed by bioelectrical impedance analysis (BIA) [Срок оценки: 3 and 6 months]
Number of participants experiencing all-cause mortality, heart failure decompensation, or heart failure-related hospitalization during follow-up [Срок оценки: 3 and 6 months]
Change in Frailty status assessed by FRAIL scale [Срок оценки: 3 and 6 months]
Change in emotional status assessed by the Hospital Anxiety and Depression Scale (HADS) [Срок оценки: 3 and 6 months]
Change in Nutritional Status assessed using the Mini Nutritional Assessment (MNA) score [Срок оценки: 3 and 6 months]
Change in Maximal Inspiratory Pressure (MIP) [Срок оценки: 3 and 6 months]
Patient satisfaction [Срок оценки: 6 months]
Patient adherence [Срок оценки: 3 months]

Критерии участия

Критерии включения

Patients hospitalized for acute heart failure in a stable phase (on a stable dose or tapering intravenous diuretics for at least 48 hours, without intravenous inotropes or vasodilators for >72 hours).
Baseline functional class II-III
Age ≥ 65 years
Able to walk >4 meters
Any range of left ventricular ejection fraction