Efficacy of 8-week Supervision in Home Based Pulmonary Rehabilitation

Completed

• Conditions: Chronic Obstructive Pulmonary Disease

• Registration Number: NCT03754881
• Lead Sponsor: Asan Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-01
• Study First Submitted: 2018-11-21
• Study First Submitted QC: 2018-11-24
• Study First Posted: 2018-11-27
• Primary Completion: 2019-05-05
• Study Completion: 2020-09-06
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-30
• Last Update Posted: 2022-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from basline Chronic obstructive pulmonary disease (COPD) assessment Test (CAT) at 8 weeks	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

Name	Time	Method
change from 6 minutes walk test at 8 weeks	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).
Change from BODE index at 8 weeks	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.
Change from the Short Form 36 Health survey (SF-36), version 2.0 at 8 weeks	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.

Trial Locations

Locations (1)

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; 🇰🇷 Seoul, Korea, Republic of