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

• ClinicalTrials.gov Identifier: NCT03561818
• Recruitment Status: Recruiting
• First Posted: June 19, 2018
• Last Update Posted: February 10, 2021
• Sponsor: Istanbul Medipol University Hospital
• Information provided by (Responsible Party): esra pehlivan, Istanbul Medipol University Hospital

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Bronchiectasis; Pulmonary Rehabilitation; Lung Diseases; Lung Diseases, Interstitial	Other: Hospital-based pulmonary rehabilitation; Other: Home-based pulmonary rehabilitation	Not Applicable

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 50 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Comparison of Pulmonary Rehabilitation Efficiency in Home-based With Hospital-based Pulmonary Rehabilitation in Bronchiectasis
• Actual Study Start Date: June 19, 2018
• Estimated Primary Completion Date: December 30, 2021
• Estimated Study Completion Date: December 30, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Hospital-based group; 2 months hospital-based pulmonary rehabilitation program	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.
Experimental: Home-based group; 2 months home-based pulmonary rehabilitation program	Other: 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.

Outcome Measures

Primary Outcome Measures :

1. Changes from baseline the 6-minute walking distance at two months. [ Time Frame: Two months ]
2. Changes from baseline the modified Medical Research Council (mMRC) scale at two months. [ Time Frame: 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.

Secondary Outcome Measures :

1. Changes from baseline the forced expiratory volume in one second at two months. [ Time Frame: 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.
2. Changes from baseline the peripheral muscle strength at two months. [ Time Frame: 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.
3. Changes from baseline the Quality of Life at two months. [ Time Frame: Two months ]
   St. George Respiratory Questionnaire

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Esra Pehlivan, PhD; +905058527913; fztesrakambur@yahoo.com

Locations

Turkey

Yedikule Chest Disease Hospital; Recruiting

Istanbul, Zeytinburnu, Turkey, 34200

Contact: Esra Pehlivan, PhD fztesrakambur@yahoo.com

Sponsors and Collaborators

Istanbul Medipol University Hospital

More Information

• Responsible Party: esra pehlivan, Principal investigator, Istanbul Medipol University Hospital
• ClinicalTrials.gov Identifier: NCT03561818
• Other Study ID Numbers: PR_bronchiectasis
• First Posted: June 19, 2018
• Last Update Posted: February 10, 2021
• Last Verified: December 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Lung Diseases; Bronchiectasis; Lung Diseases, Interstitial; Respiratory Tract Diseases; Bronchial Diseases