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Набор скоро начнётся NCT07310992

Effect of Meditation as an Adjunct to Cardiac Rehabilitation

Без фазы С лечением High Blood Pressure (& [Essential Hypertension]) Meditation Training Rehabilitation Exercise

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: Meditation, Standard Cardiac Rehabilitation.
Кому может быть актуально
Состояния в реестре: High Blood Pressure (& [Essential Hypertension]), Meditation Training, Rehabilitation Exercise. 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
Список центров уточняется — проверьте первичный протокол.
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

The Effect of Meditation Practice Combined With Cardiac Rehabilitation on Improving Quality of Life and Controlling Blood Pressure.

Обзор

Cardiovascular rehabilitation is a well-established standard of care that significantly reduces morbidity and mortality while improving quality of life. However, integrating behavioral interventions into physical training may offer additional benefits for autonomic regulation and emotional well-being. This randomized clinical trial aims to investigate the efficacy of adding a brief, guided mindfulness meditation session to a standard cardiovascular rehabilitation program. The study seeks to determine whether this combined intervention enhances blood pressure control, improves perceived quality of life, and increases patient adherence compared to standard rehabilitation alone. Participants newly enrolled in the Cardiac Rehabilitation Service will be randomized into two groups. Both groups will undergo a standard 12-week regimen of aerobic and resistance training combined with optimized medical therapy. The intervention group will additionally receive 15 minutes of voice-guided mindfulness meditation at the end of each exercise session. Key outcome measures include blood pressure variability, quality of life scores (assessed via EQ-5D), and attendance rates.

Вмешательства

  • Поведенческое Meditation
    Participants in this group will undergo the standard cardiac rehabilitation program consisting of 60 minutes of aerobic and resistance training, twice a week for 12 weeks. Additionally, they will participate in a 15-minute voice-guided mindfulness meditation session immediately following each exercise session. Participants also receive optimized medical therapy.
  • Процедура Standard Cardiac Rehabilitation
    Participants in this group will undergo the standard cardiac rehabilitation program consisting of 60 minutes of aerobic and resistance training, twice a week for 12 weeks, along with optimized medical therapy. This group does not receive the guided meditation intervention.

Первичные конечные точки

  • Quality of Life Scores (EuroQol EQ-5D Visual Analogue Scale) [Срок оценки: Baseline and Week 12]
Вторичные конечные точки (2)
  • Change in Systolic and Diastolic Blood Pressure [Срок оценки: Baseline and Week 12]
  • Rate of Rehabilitation Adherence [Срок оценки: Through study completion, an average of 12 weeks]

Критерии участия

Критерии включения

  • Patients of both sexes, aged 18 years or older.
  • Newly enrolled in the Phase II Cardiac Rehabilitation Program.
  • Clinically stable condition with medical clearance to perform aerobic and resistance exercises.
  • Diagnosis of cardiovascular disease (e.g., coronary artery disease, post-myocardial infarction, post-cardiac surgery, or stable heart failure) warranting rehabilitation.
  • Willingness and cognitive ability to provide written informed consent.
  • Availability to attend the twice-weekly sessions for the 12-week duration of the study.

Критерии исключения

  • Current regular practice of meditation, yoga, or other mind-body techniques (defined as formal practice more than once a week in the previous 3 months).
  • Current participation in other psychological or behavioral intervention clinical trials.
  • Severe cognitive impairment or psychiatric disorders that preclude understanding of the meditation instructions or group participation (e.g., dementia, untreated psychosis).
  • Unstable clinical conditions such as unstable angina, uncontrolled arrhythmias, or decompensated heart failure that contraindicate physical exercise.
  • Significant orthopedic or neurological limitations that prevent the performance of the exercise protocol.
  • Refusal to participate in the randomization process.

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07310992 · 91829725.6.0000.5462

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗