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Идёт набор NCT06579612

The Benefits of Individualized Follow-up With a Sport-Health Professional in the Care of Patients With Chronic Respiratory Diseases

Без фазы С лечением Chronic Respiratory 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: Personalized follow-up and support.
Кому может быть актуально
Состояния в реестре: Chronic Respiratory Disease. Базовые параметры: 18 лет — 80 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
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Официальное название

The Benefits of Individualized Follow-up With a Sport-Health Professional in the Care of Patients With Chronic Respiratory Diseases, to Maintain Long-term Benefits After a Respiratory Rehabilitation Program

Обзор

Pulmonary rehabilitation is an integral part of care for patients with chronic respiratory diseases. It improves patients' physical capacities, quality of life and symptoms, at least in the short term. The hypothesis that patients receiving personalized support from a professional following pulmonary rehabilitation will maintain long-term benefits. This study concerns patients with a diagnosis of one or more chronic respiratory diseases. It is a multicenter, blinded, randomized controlled superiority trial in 2 parallel arms: * a group comparing follow-up and personalized support after a pulmonary rehabilitation program (experimental group) * a control group receiving only usual care

Подробное описание

Pulmonary rehabilitation is an integral part of care for patients with chronic respiratory diseases. It improves patients' physical capacities, quality of life and symptoms, at least in the short term.

The hypothesis that patients receiving personalized support from a professional following pulmonary rehabilitation will maintain long-term benefits.

This study concerns patients with a diagnosis of one or more chronic respiratory diseases.

It is a multicenter, blinded, randomized controlled superiority trial in 2 parallel arms:

* a group comparing follow-up and personalized support after a pulmonary rehabilitation program (experimental group) * a control group receiving only usual care

Each patient is followed up for 24 months with a visit every 6 months. A total of 352 subjects will be recruited

Вмешательства

  • Другое Personalized follow-up and support
    After a pulmonary rehabilitation program, an interview with a professional will enable the professional to identify the barriersand enablers of physical activity engagement, and to identify (with the patient) a plan for maintaining a physical activities adapted in daily life. Adapted solutions will then be proposed.

Первичные конечные точки

  • Difference in average number of daily steps [Срок оценки: At inclusion (V1) and at 24 Months (V5)]
Вторичные конечные точки (12)
  • Cost-utility comparison between the two groups [Срок оценки: At 24 Months (V5)]
  • Comparison of changes in physical activity levels between the two groups [Срок оценки: At 24 Months (V5)]
  • Comparison of changes in physical capacities between the two groups [Срок оценки: A 24 Months (V5)]
  • Comparison of changes in physical capacities between the two groups [Срок оценки: A 24 Months (V5)]
  • Comparison of changes in physical capacities between the two groups [Срок оценки: A 24 Months (V5)]
  • Comparison of changes in symptoms between the two groups [Срок оценки: At 24 Months (V5)]
  • Comparison of changes in psychological dimensions between the two groups [Срок оценки: At 24 Months (V5)]
  • Comparison of changes in psychological dimensions between the two groups [Срок оценки: At 24 Months (V5)]
  • Comparison of changes in health indicator between the two groups [Срок оценки: At 24 Months (V5)]
  • Comparison of changes in quality of life indicator between the two groups [Срок оценки: At 24 Months (V5)]
  • Comparison of changes in parameters (barriers and levers to physical activity) between the two groups [Срок оценки: At 24 Months (V5)]
  • Comparison of changes in physical capacities between the two groups [Срок оценки: At 24 Months (V5)]

Критерии участия

Критерии включения

  • Diagnosis of one or more chronic respiratory diseases (asthma, chronic obstructive pulmonary disease, diffuse interstitial lung disease, bronchiectasis, obstructive sleep apnea syndrome, etc.).
  • Participation in a respiratory pulmonary program
  • Have given consent
  • Patient of legal age
  • Patient affiliated to Social Security

Критерии исключения

  • Any medical contraindication to the practice of adapted physical activity in rehabilitation
  • Patients under guardianship or curatorship
  • Patients deprived of their liberty
  • Patients over 80 years of age at the time of inclusion.

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
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

Франция · 2 центра
  • CHU de Brest — Brest
  • CH des Pays de Morlaix — Morlaix

Идентификаторы

NCT: NCT06579612 · 29BRC22.0256

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗