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Идёт набор NCT07305454

Impact of a Structured Therapeutic Education Session on the Practice of Adapted Physical Activity in Chronic Inflammatory Bowel Diseases

Наблюдательное Chronic Inflammatory Bowel Disease

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: Inflammatory Bowek Disk Questionnaires, Short-International Physical Activity Questionnaries.
Кому может быть актуально
Состояния в реестре: Chronic Inflammatory Bowel Disease. Базовые параметры: 18 лет — 100 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
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

Chronic inflammatory bowel diseases (IBD; including Crohn's disease and ulcerative colitis) significantly impact patients' quality of life. Among non-pharmacological therapies, adapted physical activity (APA) has demonstrated its beneficial impact, particularly on fatigue, anxiety, digestive symptoms, and the overall quality of life of patients with IBD. The real-world implementation of APA remains insufficient, primarily due to limited patient adherence to this prescription. Patient therapeutic education (PTE) represents a potentially powerful lever for promoting engagement in APA by addressing barriers related to a lack of awareness (fear of symptom worsening) and lack of motivation. No dedicated study has specifically evaluated the effect of targeted PTE sessions on adherence to physical activity in IBD. The objective of the present feasibility study will be to determine whether a single therapeutic education session focused on the digestive and systemic benefits of APA has an impact on the rate of physical activity practice in the medium term among patients with IBD in clinical remission for at least 3 months.

Вмешательства

  • Диагностический тест Inflammatory Bowek Disk Questionnaires
    Patients will be asked to complete the questionnaires regarding bowel inflammation at enrollment, 6 months later, and 12 months later.
  • Другое Short-International Physical Activity Questionnaries
    Patients will be asked to complete the physical activity questionnaire 6 months later and 12 months later.

Первичные конечные точки

  • Effectiveness of therapeutic education intervention on physical activity practice [Срок оценки: 12 months after the inclusion]
Вторичные конечные точки (8)
  • study the impact on quality of life at 6 months [Срок оценки: 6 months after the inclusion]
  • Study the impact on quality of life in 12 months [Срок оценки: 12 months after the inclusion]
  • study the impact on fatigue reported at 6 months [Срок оценки: 6 months after the inclusion]
  • study the impact on fatigue reported at 12 months [Срок оценки: 12 months after the inclusion]
  • study the correlation between increased overall muscle strength and improved quality of life [Срок оценки: 12 months after the inclusion]
  • Study of the impact on the evolution of IBD activity at 6 months [Срок оценки: 6 months after the inclusion]
  • Study of the impact on the evolution of IBD activity at 12 months [Срок оценки: 12 months after the inclusion]
  • study the impact on the monitoring of the prescription of adapted physical activity [Срок оценки: 12 months after the inclusion]

Критерии участия

Критерии включения

  • Confirmed diagnosis of Inflammatory Bowel Disease
  • Crohn's disease in clinical remission (defined by a Harvey Bradshaw Index ≤ 5) or ulcerative colitis in clinical remission (defined by a Mayo score < 3 and no subscore > 1) for at least 3 months
  • Social Security coverage

Критерии исключения

  • Pregnant or breastfeeding woman
  • Patient under legal guardianship
  • Cardiovascular or rheumatic conditions contraindicating participation in sports
  • Neurological conditions with residual deficits contraindicating participation in sports
  • Refusal or inability to consent to participation

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

Франция · 1 центр
  • Service de Gastro-Entérologie, CHU Toulouse, Hôpital Rangueil, 1 avenue Jean Poulhès — Toulouse

Идентификаторы

NCT: NCT07305454 · RC31/25/0588 · ID-RCB

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗