Comparison of the Effectiveness of Home and Hospital-based PR in Candidate Patients With BLVR
Primary Purpose
Emphysema, Bronchoscopic Lung Volume Reduction, Hospital-based Pulmonary Rehabilitation
Status
Completed
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 treatment trial for Emphysema
Eligibility Criteria
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.
Sites / Locations
- Yedikule Chest Disease Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Hospital-based PR group
Home-based PR group
Arm Description
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 at home
Outcomes
Primary Outcome Measures
Change from baseline distance covered in six-minute walk test at 8 weeks
Change from baseline modified Medical Council Dyspnea score at 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.
Change from baseline Chronic Obstructive Airway Disease assesment test(CAT) score at 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.
Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 8 weeks
Secondary Outcome Measures
Full Information
NCT ID
NCT03518177
First Posted
April 25, 2018
Last Updated
March 6, 2019
Sponsor
Istanbul Medipol University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03518177
Brief Title
Comparison of the Effectiveness of Home and Hospital-based PR in Candidate Patients With BLVR
Official Title
Comparison of the Effectiveness of Home and Supervised Pulmonary Rehabilitation in Candidate Patients With Bronchoscopic Lung Volume Reduction
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
May 15, 2018 (Actual)
Primary Completion Date
November 1, 2018 (Actual)
Study Completion Date
December 1, 2018 (Actual)
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 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emphysema, Bronchoscopic Lung Volume Reduction, Hospital-based Pulmonary Rehabilitation, Home-based Pulmonary Rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two parallel groups will be formed from patients with hospital-based pulmonary rehabilitation (Group 1) and those with home-based pulmonary rehabilitation(Group 2).
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hospital-based PR group
Arm Type
Experimental
Arm Description
The patient will receive an 8-week supervised Pulmonary Rehabilitation Exercise Program at hospital
Arm Title
Home-based PR group
Arm Type
Experimental
Arm Description
The patient will receive an 8-week Pulmonary Rehabilitation Exercise Program at home
Intervention Type
Other
Intervention Name(s)
Hospital-based pulmonary rehabilitation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Home-based pulmonary rehabilitation
Intervention Description
The patient will receive an 8-week Pulmonary Rehabilitation Exercise Program including breathing exercises, free-walking, and strengthening training with free weights at home
Primary Outcome Measure Information:
Title
Change from baseline distance covered in six-minute walk test at 8 weeks
Time Frame
8 weeks
Title
Change from baseline modified Medical Council Dyspnea score at 8 weeks
Description
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.
Time Frame
8 weeks
Title
Change from baseline Chronic Obstructive Airway Disease assesment test(CAT) score at 8 weeks
Description
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.
Time Frame
8 weeks
Title
Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 8 weeks
Time Frame
8 weeks
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:
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.
Facility Information:
Facility Name
Yedikule Chest Disease Hospital
City
Istanbul
State/Province
Zeytinburnu
ZIP/Postal Code
34200
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32709500
Citation
Pehlivan E, Yazar E, Balci A, Turan D, Demirkol B, Cetinkaya E. A comparative study of the effectiveness of hospital-based versus home-based pulmonary rehabilitation in candidates for bronchoscopic lung volume reduction. Heart Lung. 2020 Nov-Dec;49(6):959-964. doi: 10.1016/j.hrtlng.2020.06.011. Epub 2020 Jul 21.
Results Reference
derived
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Comparison of the Effectiveness of Home and Hospital-based PR in Candidate Patients With BLVR
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