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The Effect of Pulmonary Rehabilitation on Bronchoscopic Volume Reduction Process Success

Primary Purpose

Emphysema, Pulmonary Rehabilitation, Bronchoscopic Lung Volume Reduction

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pulmonary Rehabilitation
Standart care
Sponsored by
Istanbul Medipol University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Emphysema

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Between the ages of 18-75
  • Patients with a diagnosis of emphysema and bronchoscopic procedures

Exclusion Criteria:

• Patients who develop complications related to the procedure after bronchoscopic procedure.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Pulmonary Rehabilitation Group

    Non-Pulmonary Rehabilitation Group

    Arm Description

    Optimal medication and clinical follow-up plus Pulmonary rehabiltation

    Optimal medication and clinical follow-up

    Outcomes

    Primary Outcome Measures

    Six minute walking test
    The test was conducted in a 30-meter corridor in line with American Thoracic Society (ATS) guidelines. Patients were asked to walk as far as they can. Prior to and following the test, oxygen saturation, heart rate and Borg fatigue rating were measured, and the walking distance were recorded
    Pulmonary Function Tests
    PFTs were performed by using the Sensormedics model 2400 (Yorba Linda, CA, USA) spirometry device, and according to the American Thoracic Society (ATS) guidelines

    Secondary Outcome Measures

    Carbonmonoxide diffusion test
    It will performed in the pulmonary function test laboratory using Cosmed Quark PFT (USA) with single-breath technique

    Full Information

    First Posted
    April 13, 2020
    Last Updated
    August 18, 2020
    Sponsor
    Istanbul Medipol University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04347044
    Brief Title
    The Effect of Pulmonary Rehabilitation on Bronchoscopic Volume Reduction Process Success
    Official Title
    The Effect of Pulmonary Rehabilitation on Bronchoscopic Volume Reduction Process Success
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2013 (Actual)
    Primary Completion Date
    August 18, 2020 (Actual)
    Study Completion Date
    August 18, 2020 (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

    5. Study Description

    Brief Summary
    The data of patients undergoing bronchoscopic volume reduction procedure will be analyzed retrospectively. Patients will be divided into two groups as patients with and without Pulmonary Rehabilitation before the procedure, and changes in functional levels of patients will be compared.
    Detailed Description
    The data of patients who underwent bronchoscopic volume reduction between January 2013 and March 2019 will be examined. Patients will be divided into two groups as pulmonary rehabilitation applied (PR group) and not applied (Control group) before the procedure. Changes in the parameters of initial and rehabilitation follow-up will be examined.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Emphysema, Pulmonary Rehabilitation, Bronchoscopic Lung Volume Reduction

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    80 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Pulmonary Rehabilitation Group
    Arm Type
    Experimental
    Arm Description
    Optimal medication and clinical follow-up plus Pulmonary rehabiltation
    Arm Title
    Non-Pulmonary Rehabilitation Group
    Arm Type
    Active Comparator
    Arm Description
    Optimal medication and clinical follow-up
    Intervention Type
    Other
    Intervention Name(s)
    Pulmonary Rehabilitation
    Intervention Description
    Exercise training+ Optimal medication and clinical follow-up
    Intervention Type
    Other
    Intervention Name(s)
    Standart care
    Intervention Description
    Optimal medication and clinical follow-up
    Primary Outcome Measure Information:
    Title
    Six minute walking test
    Description
    The test was conducted in a 30-meter corridor in line with American Thoracic Society (ATS) guidelines. Patients were asked to walk as far as they can. Prior to and following the test, oxygen saturation, heart rate and Borg fatigue rating were measured, and the walking distance were recorded
    Time Frame
    20 minutes
    Title
    Pulmonary Function Tests
    Description
    PFTs were performed by using the Sensormedics model 2400 (Yorba Linda, CA, USA) spirometry device, and according to the American Thoracic Society (ATS) guidelines
    Time Frame
    15 minutes
    Secondary Outcome Measure Information:
    Title
    Carbonmonoxide diffusion test
    Description
    It will performed in the pulmonary function test laboratory using Cosmed Quark PFT (USA) with single-breath technique
    Time Frame
    15 minutes

    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 18-75 Patients with a diagnosis of emphysema and bronchoscopic procedures Exclusion Criteria: • Patients who develop complications related to the procedure after bronchoscopic procedure.

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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