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Comparison of the Effectiveness of Home and Hospital-based PR in Candidate Patients With BLVR

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ClinicalTrials.gov Identifier: NCT03518177
Recruitment Status : Completed
First Posted : May 8, 2018
Last Update Posted : March 8, 2019
Sponsor:
Information provided by (Responsible Party):
esra pehlivan, Istanbul Medipol University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Emphysema Bronchoscopic Lung Volume Reduction Hospital-based Pulmonary Rehabilitation Home-based Pulmonary Rehabilitation Other: Hospital-based pulmonary rehabilitation Other: Home-based pulmonary rehabilitation Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Comparison of the Effectiveness of Home and Supervised Pulmonary Rehabilitation in Candidate Patients With Bronchoscopic Lung Volume Reduction
Actual Study Start Date : May 15, 2018
Actual Primary Completion Date : November 1, 2018
Actual Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arms and Interventions
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Arm Intervention/treatment
Experimental: Hospital-based PR group
The patient will receive an 8-week supervised Pulmonary Rehabilitation Exercise Program at hospital
 Other: Hospital-based pulmonary rehabilitation
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
 Other: Home-based pulmonary rehabilitation
The patient will receive an 8-week Pulmonary Rehabilitation Exercise Program including breathing exercises, free-walking, and strengthening training with free weights at home


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline distance covered in six-minute walk test at 8 weeks [ Time Frame: 8 weeks ]
  2. 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.

  3. 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.

  4. Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 8 weeks [ Time Frame: 8 weeks ]

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03518177


Locations
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Turkey
Yedikule Chest Disease Hospital
Istanbul, Zeytinburnu, Turkey, 34200
Sponsors and Collaborators
Istanbul Medipol University Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: esra pehlivan, Principal Investigator, Istanbul Medipol University Hospital
ClinicalTrials.gov Identifier: NCT03518177    
Other Study ID Numbers: esra pehlivan
First Posted: May 8, 2018    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Emphysema
Pathologic Processes