Comparison of PR Efficiency in Home-based With Hospital-based PR in Bronchiectasis
Primary Purpose
Bronchiectasis, Pulmonary Rehabilitation, Lung Diseases
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Hospital-based pulmonary rehabilitation
Home-based pulmonary rehabilitation
Sponsored by
About this trial
This is an interventional supportive care trial for Bronchiectasis
Eligibility 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
Sites / Locations
- Yedikule Chest Disease HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Hospital-based group
Home-based group
Arm Description
2 months hospital-based pulmonary rehabilitation program
2 months home-based pulmonary rehabilitation program
Outcomes
Primary Outcome Measures
Changes from baseline the 6-minute walking distance at two months.
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.
Secondary Outcome Measures
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.
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.
Changes from baseline the Quality of Life at two months.
St. George Respiratory Questionnaire
Full Information
NCT ID
NCT03561818
First Posted
May 14, 2018
Last Updated
May 6, 2023
Sponsor
Istanbul Medipol University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03561818
Brief Title
Comparison of PR Efficiency in Home-based With Hospital-based PR in Bronchiectasis
Official Title
Comparison of Pulmonary Rehabilitation Efficiency in Home-based With Hospital-based Pulmonary Rehabilitation in Bronchiectasis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 19, 2018 (Actual)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medipol University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiectasis, Pulmonary Rehabilitation, Lung Diseases, Lung Diseases, Interstitial
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hospital-based group
Arm Type
Experimental
Arm Description
2 months hospital-based pulmonary rehabilitation program
Arm Title
Home-based group
Arm Type
Experimental
Arm Description
2 months home-based pulmonary rehabilitation program
Intervention Type
Other
Intervention Name(s)
Hospital-based pulmonary rehabilitation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Home-based pulmonary rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes from baseline the 6-minute walking distance at two months.
Time Frame
Two months
Title
Changes from baseline the modified Medical Research Council (mMRC) scale at two months.
Description
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.
Time Frame
Two months
Secondary Outcome Measure Information:
Title
Changes from baseline the forced expiratory volume in one second at two months.
Description
The Pulmonary Function Test conducted using a Sensor Medics model 2400 device (Yorba Linda, CA, USA), in line with American Thoracic Society (ATS) guidelines.
Time Frame
Two months
Title
Changes from baseline the peripheral muscle strength at two months.
Description
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.
Time Frame
Two months
Title
Changes from baseline the Quality of Life at two months.
Description
St. George Respiratory Questionnaire
Time Frame
Two months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Esra Pehlivan, PhD
Phone
+905058527913
Email
fztesrakambur@yahoo.com
Facility Information:
Facility Name
Yedikule Chest Disease Hospital
City
Istanbul
State/Province
Zeytinburnu
ZIP/Postal Code
34200
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Esra Pehlivan, PhD
Email
fztesrakambur@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Comparison of PR Efficiency in Home-based With Hospital-based PR in Bronchiectasis
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