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Идёт набор NCT06528561

Impact of a Physical Exercise Program on the Self-care Capacity of People Hospitalized for 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: Sef-care program with exercise.
Кому может быть актуально
Состояния в реестре: Heart Failure. 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
Португалия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

The objective of the study is to evaluate the effectiveness of a self-care program that integrates physical exercise with components of aerobic and muscular strength training in improving functional capacity and muscular strength in people hospitalized for decompensated heart failure, in a clinical stabilization phase The main question it aims to answer is: Is the Self-care program that integrates physical exercise with aerobic and muscular strength training components effective in improving the capacity for self-care in people hospitalized for decompensated HF, in the clinical stabilization phase? In this randomized clinical trial, the Self-Care program will be applied in the experimental group. The ERIC-HF program will be applied in the control group. The ERIC-HF is a program of exercise only with an aerobic component. Participants will complete these programs during their hospital stay and various assessment instruments (quality of life, functional capacity, capacity for self-care, muscle strength) will be applied at admission, at discharge and one month after discharge.

Вмешательства

  • Процедура Sef-care program with exercise
    Self-care program with physical exercise with aerobic and muscular strength components implemented progressively according to the participant's clinical evolution

Первичные конечные точки

  • functional capacity - distance covered in meters with the use of the 6 Minute Walk Test [Срок оценки: immediately after the intervention (at discharge from hospitalization)]
  • Hand Grip Strength Test [Срок оценки: baseline, pre-intervention (upon admission) and immediately after the intervention (at discharge from hospitalization)]
  • Self-care skills assessed using the Self-Care of Heart Failure Index [Срок оценки: baseline, pre-intervention (upon admission) and one month after the intervention and discharge from hospitalization]
Вторичные конечные точки (3)
  • Impact of dyspnea on the various activities of daily living, assessed using the London Chest Activity of Daily Living [Срок оценки: baseline, pre-intervention (upon admission) and immediately after the intervention (at discharge from hospitalization)]
  • Functional performance of the lower limbs assessed through the score obtained using the Short physical performance battery [Срок оценки: baseline, pre-intervention (upon admission) and immediately after the intervention (at discharge from hospitalization)]
  • Quality of life perceived assessed using The Minnesota Living with Heart Failure Questionnaire [Срок оценки: baseline, pre-intervention (upon admission) and one month after the intervention and discharge from hospitalization]

Критерии участия

Критерии включения

  • Participants: Clinical diagnosis of decompensated HF, regardless of etiology or ventricular function;
  • Participants: Be over 18 years old;
  • Participants: Be able to provide informed consent.

Exclusion Criteria (participants):

  • Osteoarticular pathology that causes physical limitations that prevent the performance of physical exercise;
  • Existence of intravenous inotropic medication;
  • Uncontrolled auricular or ventricular arrhythmias;
  • Chest pain in the last 8 hours;
  • Heart rate greater than 120;
  • Dyspnea at rest;
  • Uncontrolled blood pressure - Systolic blood pressure greater than 180mmHg or diastolic blood pressure greater than 110mmHg;
  • 2nd or 3rd degree atrioventricular block;
  • Oxygen need at a rate greater than 3L/min;
  • Glycemic decompensation in the last 12 hours.

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

Португалия · 1 центр
  • Centro Hospitalar Universitário de Santo António - ULS Santo António — Porto

Идентификаторы

NCT: NCT06528561 · 2023.226(186-DEFI/178-CE)

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗