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Идёт набор NCT06235502

Long-term Home-based Exercise for Patients With COPD: the COPDtoParis Project

Без фазы С лечением Telerehabilitation COPD Quality of Life Mobility Limitation

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: Home-based cycle-exercise for COPD patients, Standard of Care.
Кому может быть актуально
Состояния в реестре: Telerehabilitation, COPD, Quality of Life, Mobility Limitation. 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
Дания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

A Cluster Randomised Controlled Trial on the Effects of Long-term Home-based Exercise for Patients With Chronic Obstructive Pulmonary Disease With Recent Exacerbation: the COPDtoParis Project

Обзор

This randomised controlled trial (RCT) aims to investigate the effect of long-term, interactive home-based cycle-exercise on patients with Chronic Obstructive Pulmonary Disease (COPD) after a COPD exacerbation requiring hospitalisation. The investigators aim to investigate if patients can maintain or improve the effects of pulmonary rehabilitation in terms of walking distance, intensity of COPD symptoms, health related quality of life and Quality Adjusted Life-Years. Participants will cycle on a pedal-exerciser in the comfort of staying in the participants' own home, whilst getting visual feedback from the 4Mvideo app. The 4Mvideo technology is a Danish designed software system, where users can cycle forward a recording of a cyclist by treading on a pedal-exerciser, thereby getting some of the experience of a real-life cycling trip at home. The investigators will compare the clinical outcomes and daily activity levels with that of a control group consisting of COPD patients.

Подробное описание

Patients with chronic obstructive pulmonary disease (COPD) have a higher risk of experiencing disability, and even though participating in pulmonary rehabilitation (PR) are efficient for regaining strength, function and relieving symptoms, effects prove difficult to maintain. Furthermore, physical attendance to outpatient PR is challenging for COPD patients, many of whom are bound to their home, due to said disability and symptoms. Even in patients who follow through with the PR programme, adherence to exercise after is a major challenge.

The investigators hypothesise that an intervention group of COPD-patients, who will receive home-based cycle exercise will maintain or even improve effects on physical fitness from PR, in terms of walking distance, daily activity levels (DAL), exercise tolerance, disease prevention and health related quality of life (HRQoL).

Furthermore, the investigators hypothesise that the participants express improved motivation in terms of adhering to exercise, when participating in home-based, interactive group cycle exercise.

It is expected to measure changes in DAL, lung function, levels of dyspnoea, exercise tolerance, walking distance, mobility, COPD symptoms, activity of daily living (ADL) related performance and HRQoL of the participants, along with assessing disease prevention. Data is compared intrapersonal and in-between groups to identify differences in outcomes at an individual level, and between intervention- and control group. Furthermore, the investigators expect to uncover identifiable in-depth insights into the values and beliefs towards exercising amongst participants.

40 participants are recruited amongst COPD patients that live in Aalborg Municipality and are admitted at Aalborg University Hospital, hospitalised due to acute exacerbation of COPD. After being discharged participants are referred to rehabilitation, for most in their own home. After rehabilitation participants are randomized into either intervention group who will exercise on exercise bikes connected with tablets in their own home. The control group will receive usual care, which consists of offers of exercising in their own home according to a programme or participating in exercise at a facility center.

Вмешательства

  • Другое Home-based cycle-exercise for COPD patients
    Patients will cycle in their own home using a pedal exerciser connected to the 4M-video app
  • Другое Standard of Care
    Exercise at Fitness Center, home based exercise according to a programme

Первичные конечные точки

  • Five-repetition sit-to-stand test [Срок оценки: Baseline measurement at initation of intervention]
  • Five-repetition sit-to-stand test [Срок оценки: Changes from baseline lower limb function at follow-up are assessed at 6 weeks]
  • Five-repetition sit-to-stand test [Срок оценки: Changes from baseline lower limb function at follow-up are assessed at 6 months]
  • Five-repetition sit-to-stand test [Срок оценки: Changes from baseline lower limb function at follow-up are assessed at 12 months]
Вторичные конечные точки (12)
  • Daily Activity Levels [Срок оценки: Baseline measurement at initation of intervention]
  • Daily Activity Levels [Срок оценки: Changes from baseline activity during rehabilitation at follow-up are assessed 12 months]
  • Lung function Test (FEV1) [Срок оценки: Baseline measurement at initation of intervention]
  • Lung function Test (FEV1) [Срок оценки: Changes from baseline lung function at follow-up are assessed at 6 weeks]
  • Lung function Test (FEV1) [Срок оценки: Changes from baseline lung function at follow-up are assessed at 6 months]
  • Lung function Test (FEV1) [Срок оценки: Changes from baseline lung function at follow-up are assessed at 12 months]
  • Level of Dyspnea with the Modified Medical Research Council Dyspnoea Scale (mMRC) [Срок оценки: Baseline measurement at initation of intervention]
  • Level of Dyspnea with the Modified Medical Research Council Dyspnoea Scale (mMRC) [Срок оценки: Changes from baseline and at follow-up are assessed at 6 weeks]
  • Level of Dyspnea with the Modified Medical Research Council Dyspnoea Scale (mMRC) [Срок оценки: Changes from baseline and at follow-up are assessed at 6 months]
  • Level of Dyspnea with the Modified Medical Research Council Dyspnoea Scale (mMRC) [Срок оценки: Changes from baseline and at follow-up are assessed at 12 months]
  • Health Related Quality of Life with St. George's Respiratory Questionnaire (SGRQ) [Срок оценки: Baseline measurement at initation of intervention]
  • Health Related Quality of Life with St. George's Respiratory Questionnaire (SGRQ) [Срок оценки: Changes from baseline health related quality of life at follow-up are assessed at 6 weeks]

Критерии участия

Критерии включения

  • Adults at age > 18 years old
  • Hospital admission with COPD exacerbation with pre-existing COPD diagnosis
  • Citizens of Aalborg Municipality
  • Able to provide informed consent
  • Accepting of referral to rehabilitation

Критерии исключения

  • Terminal illness
  • Unstable heart disease, i.e., ischemic heart disease, cardiac rhythm disorders
  • Other conditions preventing participating in cycle exercise, e.g., amputation, regimens or earlier or upcoming surgeries preventing seated position, blindness
  • Inability to understand basic Danish oral and written information or giving informed consent.

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

Дания · 1 центр
  • Aalborg University Hospital — Aalborg

Публикации

  • Stoustrup AL, Thomsen LP, Andreasen J, Palsson TS, Weinreich UM. Cluster randomised controlled trial on the effects of long-term home-based exercise for patients with chronic obstructive pulmonary disease with recent exacerbation: research protocol of the COPDtoParis Project. BMJ Open Respir Res. 2025 Jan 19;12(1):e002573. doi: 10.1136/bmjresp-2024-002573. PMID 39832888

Идентификаторы

NCT: NCT06235502 · COPDtoParis

Первоисточники (государственные реестры)

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