Pulmonary Rehabilitation Program in COPD Patient

NCT05906264 | Completed

• 1 other identifier: SMC_COPD_Rehab
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Pulmonary Rehabilitation; Tele-rehabilitation

Outcome Measures

Primary Outcomes (3)

• Activity minutes in 1 month

  metabolic equivalents (METs)/day

  1 month after training

• Pulmonary function test

  Maximum phonation time (seconds)

  1 month after training

• Dyspnea scale

  mMRC dyspnea scale (0-4)

  1 month after training

Secondary Outcomes (4)

• Activity minutes in 3 months

  3 month after training

• Pulmonary function test

  3 month after training

• Dyspnea scale

  3 month after training

• Functional capacity

  3 month after training

Study Arms (2)

Pulmonary rehabilitation, Control

NO INTERVENTION

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

Pulmonary rehabilitation, Intervention

ACTIVE COMPARATOR

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

Tele-intervention BEHAVIORAL

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

Pulmonary rehabilitation, Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung medical center

Seoul, South Korea

Location

Related Publications (12)

• 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.

  PMID: 30286833 BACKGROUND

• 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.

  PMID: 20802169 BACKGROUND

• 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.

  PMID: 32217784 BACKGROUND

• 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.

  PMID: 28848899 BACKGROUND

• 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.

  PMID: 12006427 BACKGROUND

• 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.

  PMID: 27028990 BACKGROUND

• 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.

  PMID: 29983556 BACKGROUND

• 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.

  PMID: 17054186 BACKGROUND

• 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.

  PMID: 23412902 BACKGROUND

• 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.

  PMID: 16298519 BACKGROUND

• 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.

  PMID: 20090282 BACKGROUND

• 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.

  PMID: 12900694 BACKGROUND

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: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Compared to control group, interventional group will be provided tele-intervention every week, checking compliance and encouraging the rehabilitation.

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: June 15, 2023
• Study Start: June 9, 2022
• Primary Completion: March 14, 2025
• Study Completion: March 14, 2025
• Last Updated: March 18, 2025

Record last verified: 2025-03

Locations

KR (1)