Efficacy of 8-week Supervision in Home Based Pulmonary Rehabilitation

NCT03754881 | Completed DMC

• 1 other identifier: 2018-0964
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Change from basline Chronic obstructive pulmonary disease (COPD) assessment Test (CAT) at 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

  8 weeks

Secondary Outcomes (3)

• change from 6 minutes walk test at 8 weeks

  8 weeks

• Change from the Short Form 36 Health survey (SF-36), version 2.0 at 8 weeks

  8 weeks

• Change from BODE index at 8 weeks

  8 weeks

Interventions

Pulmonary rehabilitation BEHAVIORAL

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.

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic obsturctive pulmonary disease in Asan Medical Center

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (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, 138-736, South Korea

Location

Related Publications (1)

• Lee JH, Lee HY, Jang Y, Lee JS, Oh YM, Lee SD, Lee SW. Efficacy of Unsupervised Home-Based Pulmonary Rehabilitation for Patients with Chronic Obstructive Pulmonary Disease. Int J Chron Obstruct Pulmon Dis. 2020 Sep 28;15:2297-2305. doi: 10.2147/COPD.S268683. eCollection 2020.

  PMID: 33061347 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 21, 2018
• First Posted: November 27, 2018
• Study Start: September 1, 2018
• Primary Completion: May 5, 2019
• Study Completion: September 6, 2020
• Last Updated: June 1, 2022

Record last verified: 2022-05

Locations

KR (1)