Comparison of the Effectiveness of Home and Hospital-based PR in Candidate Patients With BLVR
March 6, 2019 updated by: esra pehlivan, Istanbul Medipol University Hospital
Comparison of the Effectiveness of Home and Supervised Pulmonary Rehabilitation in Candidate Patients With Bronchoscopic Lung Volume Reduction
The recent years, the use of bronchoscopic lung volume reduction in emphysema patients instead of surgical operations has become widespread.
Before this procedure, the implementation of Pulmonary Rehabilitation became a necessity.
The inadequacy of the number of Pulmonary Rehabilitation Centers in our country and in our city and the increasing number of mentioned operations have increased the need for different exercise program applications.
Prior to valve and coil applications in our study, changes in clinical conditions of patients will be examined if Pulmonary Rehabilitation is performed at home or in a hospital.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The records of emphysema patients referred to the Pulmonary Rehabilitation Unit for prophylactic pulmonary rehabilitation prior to bronchoscopic lung volume reduction will be recorded prospectively.
Two parallel groups will be formed from patients with hospital-based pulmonary rehabilitation (Group 1) and those with home-based pulmonary rehabilitation (Group 2).
The patient will receive an 8-week Pulmonary Rehabilitation Exercise Program and will be reevaluated after 8 weeks.
The differences in the parameters of initial and rehabilitation end-tracing and the differences between the groups will be examined.
Study Type
Interventional
Enrollment (Actual)
66
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Zeytinburnu
-
Istanbul, Zeytinburnu, Turkey, 34200
- Yedikule Chest Disease Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with emphysema and bronchoscopic lung volume reduction procedures decided by chest physician
- Acceptance of participation in a 2-month Pulmonary Rehabilitation program.
Exclusion Criteria:
-Possible orthopedic, cardiovascular or psychological disturbance that may prevent exercising.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Hospital-based PR group
The patient will receive an 8-week supervised Pulmonary Rehabilitation Exercise Program at hospital
|
The patient will receive an 8-week Pulmonary Rehabilitation Exercise Program including breathing exercises, treadmill walking, cycle ergometer, arm ergometer training and strengthening trainning with free weights at hospital.
|
|
Experimental: Home-based PR group
The patient will receive an 8-week Pulmonary Rehabilitation Exercise Program at home
|
The patient will receive an 8-week Pulmonary Rehabilitation Exercise Program including breathing exercises, free-walking, and strengthening training with free weights at home
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline distance covered in six-minute walk test at 8 weeks
Time Frame: 8 weeks
|
8 weeks
|
|
|
Change from baseline modified Medical Council Dyspnea score at 8 weeks
Time Frame: 8 weeks
|
The scale will rate the sensation of dyspnea as the person perceives it.The severity of dyspnea is rated on a scale of 0 to 4."0 point" means no dyspnea perception and "4point" means severe dyspnea perception.
|
8 weeks
|
|
Change from baseline Chronic Obstructive Airway Disease assesment test(CAT) score at 8 weeks
Time Frame: 8 weeks
|
The COPD Assessment Test (CAT) is a questionnaire for people with COPD.
It is designed to measure the impact of COPD on a person's life, and how this changes over time.
Range of CAT scores from 0-40.
Higher scores denote a more severe impact of COPD on a patient's life.
|
8 weeks
|
|
Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 8 weeks
Time Frame: 8 weeks
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 15, 2018
Primary Completion (Actual)
November 1, 2018
Study Completion (Actual)
December 1, 2018
Study Registration Dates
First Submitted
April 25, 2018
First Submitted That Met QC Criteria
April 25, 2018
First Posted (Actual)
May 8, 2018
Study Record Updates
Last Update Posted (Actual)
March 8, 2019
Last Update Submitted That Met QC Criteria
March 6, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- esra pehlivan
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.