Telerehabilitation in Patients With Idiopathic Pulmonary Fibrosis

Официальное название

The Effectiveness of Synchronized Online and Video-based Exercise Programs in Patients With Idiopathic Pulmonary Fibrosis

Обзор

It is to determine the effectiveness of different telerehabilitation exercise programs received to 2 groups randomly formed in idiopathic pulmonary fibrosis (IPF) patients. The cases meeting the inclusion criteria will be randomized and divided into two groups, the groups will be named as Telerehabilitation Exercise Group (TGr) and Video Group (VGr).

Подробное описание

Patients diagnosed with idiopathic pulmonary fibrosis by a chest diseases specialist and referred to pulmonary rehabilitation will be included in the study. The cases meeting the inclusion criteria will be randomized and divided into two groups, the groups will be named as Telerehabilitation Exercise Group (TGr) and Video Group (VGr). TGr will be given online exercises, synchronized 2 days a week, and a home program for 1 day, accompanied by a physiotherapist, via videoconference on the group smartphone. As for the VGr group, after 1 session of online simultaneous exercise training in the company of a physiotherapist via videoconference on the smart phone, an exercise video including the exercises will be sent to them and the patients will be asked to do their exercises 3 days a week. The subjects will be asked to keep an exercise diary and the status of the diaries will be followed by calling them once a week. The exercise period will be 8 weeks for both groups.

Вмешательства

• Другое Telerehabilitation exercise program
  TGr will be given online exercises, synchronized 2 days a week, and a home program for 1 day, accompanied by a physiotherapist, via videoconference on the group smartphone.
• Другое Videobased exercise program
  After 1 session of online simultaneous exercise training in the company of a physiotherapist via videoconference on the smart phone, an exercise video including the exercises will be sent to them and the patients will be asked to do their exercises 3 days a week. The subjects will be asked to keep an exercise diary and the status of the diaries will be followed by calling them once a week.

Первичные конечные точки

• The exercise capacity [Срок оценки: Change from baseline 6 minute walking distance at 8 weeks]

Вторичные конечные точки (9)

• Forced vital capacity (FVC) [Срок оценки: Change from baseline FVC at 8 weeks]
• Perception of dyspnea [Срок оценки: Change from baseline dyspnea perception at 8 weeks]
• Respiratory muscle strength [Срок оценки: Change from baseline respiratory muscle strength at 8 weeks]
• Peripheral muscle strength [Срок оценки: Change from baseline peripheral muscle strength at 8 weeks]
• Perception of general fatigue [Срок оценки: Change from baseline perception of general fatigue at 8 weeks]
• Saint George Respiratory Questionnaire (SGRQ) score [Срок оценки: Change from baseline SGRQ score at 8 weeks]
• Hospital anxiety and depression scale score [Срок оценки: Change from baseline anxiety level at 8 weeks]
• International Physical Activity Questionnaire- short form [Срок оценки: Change from baseline physical activity level at 8 weeks]
• Forced expiratory volume in one second (FEV1) [Срок оценки: Change from baseline FEV1 at 8 weeks]

Критерии участия

Критерии включения

• Being between the ages of 18-75
• Having a diagnosis of IPF disease diagnosed according to the following clinical diagnostic criteria according to the American Thoracic and European Respiratory Societies (ATS-ERS)
• Presence of dyspnea on exertion
• Stable clinical state at the time of admission without infection or exacerbation in the previous 4 weeks

Критерии исключения

• Patients with severe comorbid diseases, unstable coronary artery disease, collagen vascular diseases and needing high flow oxygen therapy (˃ 3-4 L \\min).
• A history of effort-related syncope or any comorbidity (such as severe orthopedic or neurological deficits or unstable heart disease) that precludes exercise training.
• Participation in a pulmonary rehabilitation program within the past 12 months.

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

Turkey (Türkiye) · 1 центр

• Yedikule Chest Disease Hospital — Istanbul

Идентификаторы

NCT: NCT05190211 · IPFTele

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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