Pulmonary Rehabilitation Program in COPD Patient

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Evaluation of Compliance and Effectiveness of Pulmonary Rehabilitation Program in COPD Patient

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05906264
• Other study ID #: SMC_COPD_Rehab
• Status: Recruiting
• Phase: N/A
• Start date: June 9, 2022
• Est. completion date: September 30, 2023

Study information

• Verified date: June 2023
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: September 30, 2023
• Est. primary completion date: August 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

• 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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Samsung medical center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Activity minutes in 1 month	metabolic equivalents (METs)/day	1 month after training
Primary	Pulmonary function test	Maximum phonation time (seconds)	1 month after training
Primary	Dyspnea scale	mMRC dyspnea scale (0-4)	1 month after training
Secondary	Activity minutes in 3 months	metabolic equivalents (METs)/day	3 month after training
Secondary	Pulmonary function test	Pulmonary function test (FEV1/FVC)	3 month after training
Secondary	Dyspnea scale	mMRC dyspnea scale (0-4)	3 month after training
Secondary	Functional capacity	6 minute walk test (m/6min)	3 month after training