Effect of Elastic Chest Compression on Functional Exercise Capacity and Respiratory Performance in Patients With COPD
1 other identifier
interventional
17
1 country
1
Brief Summary
The goal of this clinical trial is to investigate the effects of elastic chest compression on functional exercise capacity and respiratory performance of patients with COPD. The main questions it aims to answer are: Is there difference in functional exercise capacity and respiratory performance without or with the use of elastic upper chest compression? Is there difference in functional exercise capacity and respiratory performance between the use of elastic upper chest compression and elastic lower chest compression? Participants will: Be evaluated under three conditions on three different days: without elastic compression, with upper chest compression, and with lower chest compression, with the order of compression application randomly assigned. The functional capacity and respiratory muscle performance of all patients will be evaluated. The days for evaluation will be at least three days apart from each other.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 10, 2024
CompletedFirst Submitted
Initial submission to the registry
July 14, 2024
CompletedFirst Posted
Study publicly available on registry
July 25, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2027
July 25, 2024
July 1, 2024
2.9 years
July 14, 2024
July 19, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Functional exercise capacity
6 minute walk test measured in meters
up to 3 weeks
Respiratory muscle performance
Maximum inspiratory (MIP) and expiratory pressures (MEP) in mmH2O
up to 3 weeks
Respiratory flow performance
peak inspiratory (PIFR) and expiratory flows (PEFR) in liter per minute
up to 3 weeks
Study Arms (2)
Upper chest compression
EXPERIMENTALThe Theraband will be wrapped around the subject's upper chest with upper edge of the Theraband aligned to the 3rd intercostal space and fastened on the upper rib cage for the upper chest compression arm.
Lower chest compression
EXPERIMENTALThe Theraband will be wrapped around the subject's lower rib cage by placing the central horizontal part of the Theraband at the xiphoid process of the sternum for the lower chest compression arm.
Interventions
Chest compression applicated via a Red Theraband over the upper or lower chest region
Eligibility Criteria
You may qualify if:
- at least 20 years old
- has a clinical diagnosis of COPD without infection or acute exacerbation in the previous four weeks
- is capable of cooperating with the required tests and measurements of the study
You may not qualify if:
- has any clinical diagnosis that could affect test outcomes (e.g., neuromyopathy)
- has experienced unstable angina or an acute myocardial infarction within the last month
- has adjusted COPD related medication within the last month
- a Mini-Mental State Examination (MMSE) score below 24
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital Hsinchu Branch
Hsinchu, Taiwan
Related Publications (23)
Hogg JC. Lung structure and function in COPD. Int J Tuberc Lung Dis. 2008 May;12(5):467-79.
PMID: 18419881BACKGROUNDHogg JC, Timens W. The pathology of chronic obstructive pulmonary disease. Annu Rev Pathol. 2009;4:435-59. doi: 10.1146/annurev.pathol.4.110807.092145.
PMID: 18954287BACKGROUNDBaraldo S, Turato G, Saetta M. Pathophysiology of the small airways in chronic obstructive pulmonary disease. Respiration. 2012;84(2):89-97. doi: 10.1159/000341382. Epub 2012 Aug 6.
PMID: 22868355BACKGROUNDBarnes PJ, Celli BR. Systemic manifestations and comorbidities of COPD. Eur Respir J. 2009 May;33(5):1165-85. doi: 10.1183/09031936.00128008.
PMID: 19407051BACKGROUNDRossi A, Ganassini A, Polese G, Grassi V. Pulmonary hyperinflation and ventilator-dependent patients. Eur Respir J. 1997 Jul;10(7):1663-74. doi: 10.1183/09031936.97.10071663.
PMID: 9230263BACKGROUNDGagnon P, Guenette JA, Langer D, Laviolette L, Mainguy V, Maltais F, Ribeiro F, Saey D. Pathogenesis of hyperinflation in chronic obstructive pulmonary disease. Int J Chron Obstruct Pulmon Dis. 2014 Feb 15;9:187-201. doi: 10.2147/COPD.S38934. eCollection 2014.
PMID: 24600216BACKGROUNDKrieger BP. Hyperinflation and intrinsic positive end-expiratory pressure: less room to breathe. Respiration. 2009;77(3):344-50. doi: 10.1159/000192790. Epub 2009 Jan 10.
PMID: 19141987BACKGROUNDLanger D, Ciavaglia CE, Neder JA, Webb KA, O'Donnell DE. Lung hyperinflation in chronic obstructive pulmonary disease: mechanisms, clinical implications and treatment. Expert Rev Respir Med. 2014 Dec;8(6):731-49. doi: 10.1586/17476348.2014.949676. Epub 2014 Aug 27.
PMID: 25159007BACKGROUNDO'Donnell DE, Webb KA, Neder JA. Lung hyperinflation in COPD: applying physiology to clinical practice. COPD Res Pract. 2015;1(1):4
BACKGROUNDO'Donnell DE, Laveneziana P. Physiology and consequences of lung hyperinflation in COPD. Eur Respir Rev. 2006;15(100):61-67
BACKGROUNDSomfay A, Porszasz J, Lee SM, Casaburi R. Dose-response effect of oxygen on hyperinflation and exercise endurance in nonhypoxaemic COPD patients. Eur Respir J. 2001 Jul;18(1):77-84. doi: 10.1183/09031936.01.00082201.
PMID: 11510809BACKGROUNDSpahija J, Marchie Md, Ghezzo H, Grassino A. Factors discriminating spontaneous pursed-lips breathing use in patients with COPD. COPD. 2010 Aug;7(4):254-61. doi: 10.3109/15412555.2010.496820.
PMID: 20673034BACKGROUNDGigliotti F, Coli C, Bianchi R, Romagnoli I, Lanini B, Binazzi B, Scano G. Exercise training improves exertional dyspnea in patients with COPD: evidence of the role of mechanical factors. Chest. 2003 Jun;123(6):1794-802. doi: 10.1378/chest.123.6.1794.
PMID: 12796152BACKGROUNDPuente-Maestu L, Stringer WW. Hyperinflation and its management in COPD. Int J Chron Obstruct Pulmon Dis. 2006;1(4):381-400. doi: 10.2147/copd.2006.1.4.381.
PMID: 18044095BACKGROUNDIchiba T, Miyagawa T, Kera T, Tsuda T. Effect of manual chest wall compression in participants with chronic obstructive pulmonary disease. J Phys Ther Sci. 2018 Nov;30(11):1349-1354. doi: 10.1589/jpts.30.1349. Epub 2018 Nov 6.
PMID: 30464362BACKGROUNDNozoe M, Mase K, Ogino T, Murakami S, Takashima S, Domen K. Effects of chest wall compression on expiratory flow rates in patients with chronic obstructive pulmonary disease. Braz J Phys Ther. 2016 Mar 15;20(2):158-65. doi: 10.1590/bjpt-rbf.2014.0145.
PMID: 26982453BACKGROUNDMase K, Yamamoto K, Murakami S, Kihara K, Matsushita K, Nozoe M, Takashima S. Changes in ventilation mechanics during expiratory rib cage compression in healthy males. J Phys Ther Sci. 2018 Jun;30(6):820-824. doi: 10.1589/jpts.30.820. Epub 2018 Jun 12.
PMID: 29950772BACKGROUNDBrunherotti MA, Martinez FE. Response of oxygen saturation in preterm infants receiving rib cage stabilization with an elastic band in two body positions: a randomized clinical trial. Braz J Phys Ther. 2013 Mar-Apr;17(2):105-11. doi: 10.1590/S1413-35552012005000082. English, Portuguese.
PMID: 23778773BACKGROUNDCelli B, Fabbri L, Criner G, Martinez FJ, Mannino D, Vogelmeier C, Montes de Oca M, Papi A, Sin DD, Han MK, Agusti A. Definition and Nomenclature of Chronic Obstructive Pulmonary Disease: Time for Its Revision. Am J Respir Crit Care Med. 2022 Dec 1;206(11):1317-1325. doi: 10.1164/rccm.202204-0671PP. No abstract available.
PMID: 35914087BACKGROUNDPellegrino R, Brusasco V. On the causes of lung hyperinflation during bronchoconstriction. Eur Respir J. 1997 Feb;10(2):468-75. doi: 10.1183/09031936.97.10020468.
PMID: 9042651BACKGROUNDDe Troyer A. Effect of hyperinflation on the diaphragm. Eur Respir J. 1997 Mar;10(3):708-13.
PMID: 9073010BACKGROUNDDecramer M. Hyperinflation and respiratory muscle interaction. Eur Respir J. 1997 Apr;10(4):934-41.
PMID: 9150337BACKGROUNDMunari AB, Venancio RS, Gulart AA, Da Silveira JA, Klein SR, Martins AC, Mayer AF. Slow chest compression acutely reduces dynamic hyperinflation in people with chronic obstructive pulmonary disease: a randomized cross-over trial. Physiother Theory Pract. 2022 Dec;38(12):1937-1945. doi: 10.1080/09593985.2021.1907824. Epub 2021 Apr 8.
PMID: 33829946BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2024
First Posted
July 25, 2024
Study Start
July 10, 2024
Primary Completion (Estimated)
May 31, 2027
Study Completion (Estimated)
May 31, 2027
Last Updated
July 25, 2024
Record last verified: 2024-07