Comparison of PR Efficiency in Home-based With Hospital-based PR in Bronchiectasis

Официальное название

Comparison of Pulmonary Rehabilitation Efficiency in Home-based With Hospital-based Pulmonary Rehabilitation in Bronchiectasis

Обзор

The investigators aimed to compare the home-based Pulmonary Rehabilitation with the hospital-based pulmonary rehabilitation in terms of pulmonary rehabilitation efficiency in patient with bronchiectasis.

Подробное описание

While the benefits of pulmonary rehabilitation (PR) in cases of chronic obstructive pulmonary disease (COPD) have been well-documented, there have been only a limited number of studies investigating the efficacy of PR in patients with bronchiectasis. Some of these studies have reported positive effects of PR also in bronchiectasis patients, but have underlined the need for additional studies including larger patient groups to define PR indications, and to ensure that exercise protocols are specific for this patient group. There are many PR organizational types, such as hospital-based, telephone-mentoring with home-based or tele monitorization programs. Hospital-based supervised programs are time-consuming and costly practices. For this reason, there is a need for further studies on the effectiveness and benefits of unsupervised programs. In this study, we will compare unsupervised home-based PR and supervised hospital-based PR in terms of pulmonary rehabilitation effectiveness.

The pulmonary function tests, dyspnea perception, quality of life and exercise capacity assessments will performed before and after pulmonary rehabilitation.

Вмешательства

• Другое Hospital-based pulmonary rehabilitation
  The patients who undergo two days pulmonary rehabilitation under supervision in our clinic and three days a week at home during two months will taken as hospital group. The exercises include breathing exercises, treadmill (15sc), cycle training (15sc), arm ergometer training (15sc), peripheral muscle training and stretching exercises with free weights.
• Другое Home-based pulmonary rehabilitation
  The patients who follow a home-based pulmonary rehabilitation program for two months comprising breathing exercises, training in chest hygiene techniques, peripheral muscle strengthening training and self-walking for 5 days in a week for two months. An exercise follow-up form will give to the patients to record their daily exercises. A similar form will fill by physiotherapist once a week during phone call.

Первичные конечные точки

• Changes from baseline the 6-minute walking distance at two months. [Срок оценки: Two months]
• Changes from baseline the modified Medical Research Council (mMRC) scale at two months. [Срок оценки: Two months]

Вторичные конечные точки (3)

• Changes from baseline the forced expiratory volume in one second at two months. [Срок оценки: Two months]
• Changes from baseline the peripheral muscle strength at two months. [Срок оценки: Two months]
• Changes from baseline the Quality of Life at two months. [Срок оценки: Two months]

Критерии участия

Критерии включения

• Between the ages of 18-70
• Patients signing informed consent form
• Bronchiectasis patients in the stable phase who were diagnosed with High-resolution computed tomography (HRCT).

Критерии исключения

• Decompensated heart failure, uncontrolled hypertension (Systolic Blood Pressure> 200, Diastolic Blood Pressure> 110),
• Additional diseases that may prevent exercise,
• To be regularly exercising regularly

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр

• Yedikule Chest Disease Hospital — Istanbul

Идентификаторы

NCT: NCT03561818 · PR_bronchiectasis

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗