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

Lung Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03561818
• Other study ID #: PR_bronchiectasis
• Status: Recruiting
• Phase: N/A
• Start date: June 19, 2018
• Est. completion date: December 30, 2024

Study information

• Verified date: May 2023
• Source: Istanbul Medipol University Hospital
• Contact: Esra Pehlivan, PhD
• Phone: +905058527913
• Email: fztesrakambur[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Bronchiectasis
• Lung Diseases
• Lung Diseases, Interstitial
• Pulmonary Rehabilitation

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Turkey	Yedikule Chest Disease Hospital	Istanbul	Zeytinburnu

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from baseline the 6-minute walking distance at two months.		Two months
Primary	Changes from baseline the modified Medical Research Council (mMRC) scale at two months.	Dyspnea perceptions during daily life activities will assess according to the modified Medical Research Council (mMRC) scale. The mMRC Dyspnea Scale is best used to establish baseline functional impairment due to dyspnea attributable to respiratory disease; tracking the mMRC over time or with therapeutic interventions is of less certain clinical utility.The severity of dyspnea is rated on a scale of 0 to 4. "0" means no dyspnea perception, "4" means severe dyspnea perception.	Two months
Secondary	Changes from baseline the forced expiratory volume in one second at two months.	The Pulmonary Function Test conducted using a Sensor Medics model 2400 device (Yorba Linda, CA, USA), in line with American Thoracic Society (ATS) guidelines.	Two months
Secondary	Changes from baseline the peripheral muscle strength at two months.	Peripheral Muscle Strength will measure using a digital dynamometer(J-Tech Commander muscle testing device), with three measurements make in total of the quadriceps femoris, tibialis anterior and iliopsoas muscles.	Two months
Secondary	Changes from baseline the Quality of Life at two months.	St. George Respiratory Questionnaire	Two months