Efficacy of 8-week Supervision in Home Based Pulmonary Rehabilitation

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Efficacy of 8-week Supervision in Home Based Pulmonary Rehabilitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03754881
• Other study ID #: 2018-0964
• Status: Completed
• Start date: September 1, 2018
• Est. completion date: September 6, 2020

Study information

• Verified date: May 2022
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: September 6, 2020
• Est. primary completion date: May 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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.

Locations

Country	Name	City	State
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	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	change from 6 minutes walk test at 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).	8 weeks
Secondary	Change from the Short Form 36 Health survey (SF-36), version 2.0 at 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.	8 weeks
Secondary	Change from BODE index at 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.	8 weeks