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Chronic Obstructive Pulmonary DiseaseNCT05906264

Pulmonary Rehabilitation Program in COPD Patient

A study testing Tele-intervention in people with Chronic Obstructive Pulmonary Disease, run by Samsung Medical Center at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study was designed in order to evaluate the compliance of a pulmonary rehabilitation program using a wearable device and the application effect of the program according to the characteristics of each patient, in COPD patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Obstructive Pulmonary Disease
What is being tested?
Tele-intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
1 siteSouth Korea
Study dates
9 Jun 2022to 14 Mar 2025
Phase
Interventional
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • COPD patients 18 years of age or older
  • ECOG PS (Eastern Cooperative Oncology Group Performance Status) <2
  • Smart phone user
  • Those who understand the contents of the questionnaire and agree to the research

Who cannot join

  • Patients with history of lung cancer surgery
  • Patients with bronchiectasis, severe tuberculosis destroyed lung, active pulmonary tuberculosis, non-tuberculous mycobacterial lung disease (NTM), and idiopathic interstitial pneumonia

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Samsung medical center

    Seoul

Other trials in South Korea

About this study

Official title: Evaluation of Compliance and Effectiveness of Pulmonary Rehabilitation Program in COPD Patient

This study was designed in order to evaluate the compliance of a pulmonary rehabilitation program using a wearable device and the application effect of the program according to the characteristics of each patient, in COPD patients.

Read the detailed description

Chronic obstructive pulmonary disease (COPD) is characterized by persistent respiratory symptoms and airflow limitation. Symptoms of COPD often restricts exercise capacity and activities of daily life of patients. Accordingly, patients with symptomatic COPD have reduced health-related quality of life, which leads to substantial socioeconomic burden.

In order to overcome the limitation associated with COPD pharmacotherapy, the need for a combination of nonpharmacologic therapies, including pulmonary rehabilitation has been suggested constantly. Pulmonary rehabilitation is a method of relieving respiratory distress symptoms through exhalation and inspiratory training, improving exercise ability and contributes in improving lung function and overall quality of life.

Nevertheless, compliance of pulmonary rehabilitation in daily life is low in most COPD patients. Thus, we applied wearable device to detect and evaluate application, compliance and effectiveness pulmonary rehabilitation program in COPD patients, according to the patients' characteristics. Moreover, we sought to use the results of this study as a basic data to establish a strategy for a customized education program for each patient that can be applied to non-face-to-face digital therapeutics in the future.

Being tested
Tele-intervention
Keywords
Pulmonary Rehabilitation, Tele-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.

  • Tele-interventionBehavioural

    Tele-intervention every week to check compliance and encourage the rehabilitation

Study groups in NCT05906264
Study groupRoleWhat they receive
Pulmonary rehabilitation, ControlNo interventionfor COPD patients, who have been trained with the pulmonary rehabilitation program * Compliance will be checked by monitoring wearable device at one month * Pulmonary function and symptom improvement effect will be checked at 3 months
Pulmonary rehabilitation, InterventionActive comparatorCompared to Control group, Intervention group will be provided with additional tele-intervention every week to check the compliance and encourage of the rehabilitation
Receives: Behavioral: Tele-intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Activity minutes in 1 month

    metabolic equivalents (METs)/day

    Measured: 1 month after training

  2. Pulmonary function test

    Maximum phonation time (seconds)

    Measured: 1 month after training

  3. Dyspnea scale

    mMRC dyspnea scale (0-4)

    Measured: 1 month after training

Secondary outcomes (4)

  1. Activity minutes in 3 months

    metabolic equivalents (METs)/day

    Measured: 3 month after training

  2. Pulmonary function test

    Pulmonary function test (FEV1/FVC)

    Measured: 3 month after training

  3. Dyspnea scale

    mMRC dyspnea scale (0-4)

    Measured: 3 month after training

  4. Functional capacity

    6 minute walk test (m/6min)

    Measured: 3 month after training

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2023
  2. Study start9 Jun 2022
  3. Primary completion14 Mar 2025
  4. Study completion14 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Compared to control group, interventional group will be provided tele-intervention every week, checking compliance and encouraging the rehabilitation.
Masking
None (open label)
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05906264
Sponsor's protocol ID
SMC_COPD_Rehab
Status last verified
Mar 2025
First submitted
19 Apr 2022
Last updated
18 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Mirza S, Clay RD, Koslow MA, Scanlon PD. COPD Guidelines: A Review of the 2018 GOLD Report. Mayo Clin Proc. 2018 Oct;93(10):1488-1502. doi: 10.1016/j.mayocp.2018.05.026.

    PubMed 30286833

  • Eisner MD, Anthonisen N, Coultas D, Kuenzli N, Perez-Padilla R, Postma D, Romieu I, Silverman EK, Balmes JR; Committee on Nonsmoking COPD, Environmental and Occupational Health Assembly. An official American Thoracic Society public policy statement: Novel risk factors and the global burden of chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2010 Sep 1;182(5):693-718. doi: 10.1164/rccm.200811-1757ST.

    PubMed 20802169

  • Mathioudakis AG, Janssens W, Sivapalan P, Singanayagam A, Dransfield MT, Jensen JS, Vestbo J. Acute exacerbations of chronic obstructive pulmonary disease: in search of diagnostic biomarkers and treatable traits. Thorax. 2020 Jun;75(6):520-527. doi: 10.1136/thoraxjnl-2019-214484. Epub 2020 Mar 26.

    PubMed 32217784

  • Simmering JE, Polgreen LA, Comellas AP, Cavanaugh JE, Polgreen PM. Identifying Patients With COPD at High Risk of Readmission. Chronic Obstr Pulm Dis. 2016 Aug 29;3(4):729-738. doi: 10.15326/jcopdf.3.4.2016.0136.

    PubMed 28848899

  • Miravitlles M, Murio C, Guerrero T, Gisbert R; DAFNE Study Group. Decisiones sobre Antibioticoterapia y Farmacoeconomia en la EPOC. Pharmacoeconomic evaluation of acute exacerbations of chronic bronchitis and COPD. Chest. 2002 May;121(5):1449-55. doi: 10.1378/chest.121.5.1449.

    PubMed 12006427

  • Ko FW, Chan KP, Hui DS, Goddard JR, Shaw JG, Reid DW, Yang IA. Acute exacerbation of COPD. Respirology. 2016 Oct;21(7):1152-65. doi: 10.1111/resp.12780. Epub 2016 Mar 30.

    PubMed 27028990

  • Zeng Y, Jiang F, Chen Y, Chen P, Cai S. Exercise assessments and trainings of pulmonary rehabilitation in COPD: a literature review. Int J Chron Obstruct Pulmon Dis. 2018 Jun 26;13:2013-2023. doi: 10.2147/COPD.S167098. eCollection 2018.

    PubMed 29983556

  • Lacasse Y, Goldstein R, Lasserson TJ, Martin S. Pulmonary rehabilitation for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2006 Oct 18;(4):CD003793. doi: 10.1002/14651858.CD003793.pub2.

    PubMed 17054186

  • Ribeiro F, Theriault ME, Debigare R, Maltais F. Should all patients with COPD be exercise trained? J Appl Physiol (1985). 2013 May;114(9):1300-8. doi: 10.1152/japplphysiol.01124.2012. Epub 2013 Feb 14.

    PubMed 23412902

  • Oga T, Nishimura K, Tsukino M, Hajiro T, Mishima M. Dyspnoea with activities of daily living versus peak dyspnoea during exercise in male patients with COPD. Respir Med. 2006 Jun;100(6):965-71. doi: 10.1016/j.rmed.2005.10.006. Epub 2005 Nov 18.

    PubMed 16298519

  • Bianchi R, Gigliotti F, Romagnoli I, Lanini B, Castellani C, Binazzi B, Stendardi L, Bruni GI, Scano G. Impact of a rehabilitation program on dyspnea intensity and quality in patients with chronic obstructive pulmonary disease. Respiration. 2011;81(3):186-95. doi: 10.1159/000273675. Epub 2010 Jan 5.

    PubMed 20090282

  • Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.

    PubMed 12900694

Questions about this trial

What is this clinical trial studying?

A study testing Tele-intervention in people with Chronic Obstructive Pulmonary Disease, run by Samsung 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 4 inclusion and 2 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 18 Mar 2025. 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?

Activity minutes in 1 month (time frame: 1 month after training). The study lists 3 primary outcomes in all. 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 NCT05906264, which also lists 12 linked publications.

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 18 Mar 2025.

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