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Efficacy of 8-week Supervision in Home Based Pulmonary Rehabilitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03754881
Recruitment Status : Unknown
Verified November 2018 by Sei Won Lee, Asan Medical Center.
Recruitment status was:  Recruiting
First Posted : November 27, 2018
Last Update Posted : November 27, 2018
Sponsor:
Information provided by (Responsible Party):
Sei Won Lee, Asan Medical Center

Study Description
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Brief Summary:
In korea, it is not easy to practice standard pulmonary rehabilitation (PR). in this study, we'll educate PR to patients and make reservation for re-visiting outpatients clinics with PR diary. we want to confirm whether patients, who perform home based PR during more than 30 minutes in 3 days per week, present improved dyspnea score or quality of life compared with non-compliance group.

Condition or disease Intervention/treatment
Chronic Obstructive Pulmonary Disease Behavioral: Pulmonary rehabilitation

Study Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Efficacy of 8-week Supervision in Home Based Pulmonary Rehabilitation
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Rehabilitation

Groups and Cohorts
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Intervention Details:
  • Behavioral: Pulmonary rehabilitation

    In this study, we'll educate pulmonary rehabilitation to patients and make reservation for re-visiting outpatients clinics with PR diary after 8 weeks.

    we want to confirm whether patients, who perform home based PR during more than 30 minutes in 3 days per week, present improved dyspnea score or quality of life compared with non-compliance group.


Outcome Measures
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Primary Outcome Measures :
  1. Change from basline Chronic obstructive pulmonary disease (COPD) assessment Test (CAT) at 8 weeks [ Time Frame: 8 weeks ]
    Self reported Patient-completed questionnaire assessing globally the impact of COPD (cough, sputum, dyspnea, chest tightness) on health status. Each item is scored 0-5, yielding a total between 0 and 40


Secondary Outcome Measures :
  1. change from 6 minutes walk test at 8 weeks [ Time Frame: 8 weeks ]
    This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD).

  2. Change from the Short Form 36 Health survey (SF-36), version 2.0 at 8 weeks [ Time Frame: 8 weeks ]
    a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability.

  3. Change from BODE index at 8 weeks [ Time Frame: 8 weeks ]
    BODE index include forced expiratory volume-one second, 6 minutes walk distance, modified Medical Research Council dyspnea scale, body mass index. The BODE Index is used to predict mortality.


Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with chronic obsturctive pulmonary disease in Asan Medical Center
Criteria

Inclusion Criteria:

  • forced expiratory volume-one second / forced vital capacity < 0.7 in post-bronchodilator pulmonary function test
  • adults 40 years or older
  • no history of acute exacerbation within 4 weeks
  • no history of education for pulmonary rehabilitation within 6 months
  • no change of medication for chronic obstructive pulmonary disease within 4 weeks
  • dyspnea more than Modified Medical Research Council grade 0

Exclusion Criteria:

  • adults under 40 years old
  • no consent
  • history of acute exacerbation within 4 weeks
  • history of education for pulmonary rehabilitation within 6 months
  • change of medication for chronic obstructive pulmonary disease within 4 weeks
  • dyspnea only Modified Medical Research Council grade 0
  • comorbidity, including cardiovascular disease, orthopedic disease, neurologic disease, optic disease, uncontrolled hypertension
  • enrolled other clinical trial
  • on long term oxygen therapy
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): NCT03754881


Locations
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Korea, Republic of
Department of Pulmonary and Critical Care Medicine and Clinical Research Center for Chronic Obstructive Airway Diseases, Asan Medical Center, University of Ulsan College of Medicine Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Sei Won Lee, MD    +82-2-3010-3990    iseiwon@gmail.com   
Sponsors and Collaborators
Asan Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sei Won Lee, Associate Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT03754881    
Other Study ID Numbers: 2018-0964
First Posted: November 27, 2018    Key Record Dates
Last Update Posted: November 27, 2018
Last Verified: November 2018
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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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases