Chronic Obstructive Pulmonary DiseaseNCT03754881
Efficacy of 8-week Supervision in Home Based Pulmonary Rehabilitation
An observational study of Chronic Obstructive Pulmonary Disease, run by Asan Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Pulmonary rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 41 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Sep 2018to 6 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic obsturctive pulmonary disease in Asan Medical Center
Who may be able to join
- 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
Who cannot join
- 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
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- comorbidity, including cardiovascular disease, orthopedic disease, neurologic disease, optic disease, uncontrolled hypertension
- enrolled other clinical trial
- on long term oxygen therapy
Trial locations and contacts
1 site in 1 country.
South Korea1 site
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
About this study
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
- Being tested
- Pulmonary rehabilitation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary rehabilitationBehavioural
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 weeks
Secondary outcomes (3)
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).
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start1 Sep 2018
- Primary completion5 May 2019
- Study completion6 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sei Won Lee, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03754881
- Sponsor's protocol ID
- 2018-0964
- Status last verified
- May 2022
- First submitted
- 21 Nov 2018
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33061347
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of 8-week Supervision in Home Based Pulmonary Rehabilitation
- ClinicalTrials.gov ID
- NCT03754881
- Acronym / sponsor ID
- 2018-0964
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 5 May 2019 (actual)
- Study completion
- 6 Sep 2020 (actual)
- First posted
- 27 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic obsturctive pulmonary disease in Asan Medical Center
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary rehabilitationIn 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. | Behavioural | – |
Primary outcome
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
3 secondary outcomes
change from 6 minutes walk test at 8 weeks
Time frame: 8 weeks
Change from the Short Form 36 Health survey (SF-36), version 2.0 at 8 weeks
Time frame: 8 weeks
Change from BODE index at 8 weeks
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
- Derived from this study: PubMed 33061347Lee 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from basline Chronic obstructive pulmonary disease (COPD) assessment Test (CAT) at 8 weeks (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03754881, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2022.