Optimized Management After Balloon Pulmonary Angioplasty in Chronic Thromboembolic Pulmonary Hypertension (POpPART)
Optimised Management After Balloon Pulmonary Angioplasty in Patients With Chronic Thromboembolic Pulmonary Hypertension
Balloon pulmonary angioplasty (BPA) is a new method of treatment for inoperable chronic thromboembolic pulmonary hypertension (CTEPH) or persistent CTEPH after surgery. BPA improves or even normalises hemodynamic parameters measured during a right heart catheterization. Nevertheless, the vast majority of patients retain dyspnea and impaired exercise capacity despite considerable hemodynamic improvements.
Pulmonary rehabilitation (RHB) can improve symptoms, quality of life and exercise capacity in patients with CTEPH. Unfortunately, access to RHB remains a concern in many countries. Tele-rehabilitation (tRHB) has been shown feasible and effective some cardiac or pulmonary diseases.
This randomized controlled study aims at comparing the effects of tRHB with the effects of simple advices regarding exercising in CTEPH patients with normalized or near-normalized pulmonary hemodynamics after BPA treatment.
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
Chronic thromboembolic pulmonary hypertension (CTEPH) is a complication of pulmonary embolism leading to dyspnea, effort limitation and sometimes right heart failure and death. Balloon pulmonary angioplasty (BPA) is a new method of treatment for inoperable CTEPH or persistent CTEPH after surgery. BPA restores blood flow in the treated areas and improves or even normalises hemodynamic parameters measured during a right heart catheterization. Nevertheless, the vast majority of patients retain dyspnea and impaired exercise capacity after angioplasty procedures.
Exercise training has been demonstrated to alleviate exercise dyspnea and to improve exercise capacity in many chronic cardiopulmonary conditions. Pulmonary rehabilitation (RHB) can improve symptoms, quality of life and exercise capacity in patients with pulmonary vascular disease of different etiologies including CTEPH. Furthermore, RHB does not present any particular risk for CTEPH patients with normalized or near-normalized pulmonary hemodynamics. Unfortunately, access to RHB remains a concern in many countries. Tele-rehabilitation (tRHB) has been shown feasible and effective some cardiac or pulmonary diseases. Our hypothesis is that tRHB may also be effective in CTEPH patients with normalized or near-normalized pulmonary hemodynamics after BPA treatment.
This randomized controlled study aims at comparing the effects of tRHB with the effects of simple advices regarding exercising in CTEPH patients with normalized or near-normalized pulmonary hemodynamics after BPA treatment.
Тип исследования
Регистрация (Ожидаемый)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Bruno Degano, MD, PhD
- Номер телефона: +33 04 76 76 50 85
- Электронная почта: BDegano@chu-grenoble.fr
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Age > 18 years old
- Patients who have undergone pulmonary angioplasty for CTEPH (group 4 of the international classification)
- Patients with a mean pulmonary artery pressure <= 30 mmHg and cardiac output > 2.5 L/min/m2 at the last angioplasty session
- Patients who had completed an incremental cardiopulmonary exercise test
- Patients affiliated to the French social security system
- Patients with signed informed consent
Exclusion Criteria:
- Patients unable to complete an incremental cardiopulmonary exercise test
- Patients unable to complete a 6-minutes walking test, 3-minutes chair raising test and a rehabilitation
- Patient unable, for technical or any other reason, to connect via the Internet for remote monitoring and/or telerehabilitation
- Patient for whom a refusal to participate in a rehabilitation programme is anticipated
- Patient who has participated in a rehabilitation programme in the 6 months prior to the date of inclusion
- Patients referred to in Articles L1121-5 to L1121-8 of the CSP (pregnant women, parturients, nursing mothers, persons deprived of their liberty by a judicial or administrative decision, persons under psychiatric care and adults subject to a legal protection measure or unable to express their consent).
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Без вмешательства: Control
Simple physical activity advices will be given to the 27 patients of the control arm
|
|
|
Экспериментальный: telerehabilitation
Patients in the tele rehabilitation arm will perform 24 1h-telerehabilition sessions (dance, gym, cardio training, yoga, ...)
|
24 sessions (less Thant 1h hour each) of tele rehabilitation.
Patients can choose among several activities (gym, dance, cardio training, ...)
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Difference of endurance time on cycloergometer
Временное ограничение: At inclusion and after 3 months
|
Expressed in seconds and calculated as follow: endurance time after 3 months - endurance time at inclusion The two tests are performed at 80% of the maximum power reached during a maximum incremental effort test (performed before inclusion)
|
At inclusion and after 3 months
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
6-minutes walking test (6MWT)
Временное ограничение: At inclusion and at Month 3
|
Distance walked in 6-min (in meters)
|
At inclusion and at Month 3
|
|
3-minutes chair rise test (3-CRT)
Временное ограничение: At inclusion and at Month 3
|
Number of rises during 3-CRT (n)
|
At inclusion and at Month 3
|
|
SF-36
Временное ограничение: At inclusion and at Month 3
|
Physical dimensions of the SF-36 questionnaire
|
At inclusion and at Month 3
|
|
Dyspnea (NYHA scale)
Временное ограничение: At inclusion, at Month 1, Month 2 and Month 3
|
Either I, II, III or IV
|
At inclusion, at Month 1, Month 2 and Month 3
|
|
Telerehabilitation
Временное ограничение: Through study completion, an average of 3 months
|
Total number of sessions achieved
|
Through study completion, an average of 3 months
|
|
St George Respiratory Questionnaire (SGRQ)
Временное ограничение: At inclusion and at Month 3
|
Total SGRQ score
|
At inclusion and at Month 3
|
|
Dyspnea (mMRC score)
Временное ограничение: At inclusion, at Month 1, Month 2 and Month 3
|
Either 0, 1, 2, 3 or 4
|
At inclusion, at Month 1, Month 2 and Month 3
|
Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Bruno Degano, MD, PhD, Chu Grenoble Alpes
Даты записи исследования
Изучение основных дат
Начало исследования (Ожидаемый)
Первичное завершение (Ожидаемый)
Завершение исследования (Ожидаемый)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- EssaiClinique_POPPART
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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