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CompletedNCT05906264Updated Mar 18, 2025

Pulmonary Rehabilitation Program in COPD Patient

An interventional study of Tele-intervention in Chronic Obstructive Pulmonary Disease, sponsored by Samsung Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-18.

Sponsored by Samsung Medical Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Chronic Obstructive Pulmonary Disease

Keywords

  • Pulmonary Rehabilitation
  • Tele-rehabilitation
03

In context

Lung Diseases, Obstructive

2,592 studies on the registry are indexed under Lung Diseases, Obstructive; 198 are open to participants now.

This study's enrollment of 64 is close to the median of 66 across 1,837 interventional studies indexed under Lung Diseases, Obstructive.

Browse Lung Diseases, Obstructive studies →

Lead sponsor

Samsung Medical Center is the lead sponsor of 980 studies on the registry; 146 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
64 participants (actual)

Study arms

  • No intervention
    Pulmonary rehabilitation, Control

    for 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

  • Active comparator
    Pulmonary rehabilitation, Intervention

    Compared to Control group, Intervention group will be provided with additional tele-intervention every week to check the compliance and encourage of the rehabilitation

    Behavioral: Tele-intervention

Interventions

  • BehavioralTele-intervention

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

06

What researchers measure

Primary outcomes

  1. Activity minutes in 1 month

    metabolic equivalents (METs)/day

    Time frame: 1 month after training

  2. Pulmonary function test

    Maximum phonation time (seconds)

    Time frame: 1 month after training

  3. Dyspnea scale

    mMRC dyspnea scale (0-4)

    Time frame: 1 month after training

Secondary outcomes

  1. Activity minutes in 3 months

    metabolic equivalents (METs)/day

    Time frame: 3 month after training

  2. Pulmonary function test

    Pulmonary function test (FEV1/FVC)

    Time frame: 3 month after training

  3. Dyspnea scale

    mMRC dyspnea scale (0-4)

    Time frame: 3 month after training

  4. Functional capacity

    6 minute walk test (m/6min)

    Time frame: 3 month after training

07

Study locations

1 site
  • Samsung medical center
    Seoul, Korea, Republic of
08

References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05906264
Lead sponsor
Samsung Medical Center
Responsible party
Sponsor
First posted
Jun 15, 2023
Start date
Jun 9, 2022
Primary completion
Mar 14, 2025
Completion
Mar 14, 2025
Last update
Mar 18, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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