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RecruitingNCT06519474Updated Jul 25, 2024

Effect of Elastic Chest Compression on Functional Exercise Capacity and Respiratory Performance in Patients With COPD

An interventional study of Theraband chest compression in COPD and Hyperinflation, sponsored by National Taiwan University Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2024-07-25.

Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2024; still recruiting 2 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
17
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study 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.

Read the detailed description

Participants will be evaluated under three conditions: without elastic compression, with upper chest compression, and with lower chest compression, with the order of compression application randomly assigned. A Red Theraband will be used to apply compression to the upper and lower regions of the chest. For a standardized approach to apply compression, the top edge will be aligned with the 3rd intercostal space for the upper chest compression, while the central horizontal part will line up with the xiphoid process of the sternum for the lower chest compression. After exhaling to the EELV, the circumferences of the upper and lower chest regions will be measured, using the 3rd intercostal space as the measurement mark for the upper chest and the xiphoid process of the sternum as the measurement marks for the lower chest. The Thera-Band will be adjusted to 90% of the measured circumferences, ensuring it is securely fastened and standardized resistance is applied consistently to the thoracic regions of interest throughout the study. After chest compression is applied, participants will undergo measurements for functional exercise capacity and respiratory muscle performance.

02

Conditions studied

  • COPD
  • Hyperinflation

Keywords

  • chronic obstructive pulmonary disease
  • dynamic hyperinflation
  • elastic chest compression
  • functional exercise capacity
  • respiratory performance
03

In context

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

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

04

Who can participate

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

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
17 participants (estimated)

Study arms

  • Experimental
    Upper chest compression

    The 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.

    Device: Theraband chest compression

  • Experimental
    Lower chest compression

    The 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.

    Device: Theraband chest compression

Interventions

  • DeviceTheraband chest compression

    Chest compression applicated via a Red Theraband over the upper or lower chest region

06

What researchers measure

Primary outcomes

  1. Functional exercise capacity

    6 minute walk test measured in meters

    Time frame: up to 3 weeks

  2. Respiratory muscle performance

    Maximum inspiratory (MIP) and expiratory pressures (MEP) in mmH2O

    Time frame: up to 3 weeks

  3. Respiratory flow performance

    peak inspiratory (PIFR) and expiratory flows (PEFR) in liter per minute

    Time frame: up to 3 weeks

07

Study locations

1 of 1 sites recruiting
  • National Taiwan University Hospital Hsinchu Branch
    Hsinchu, Taiwan
    Recruiting
08

References and documents

Publications

  • Hogg JC. Lung structure and function in COPD. Int J Tuberc Lung Dis. 2008 May;12(5):467-79. PubMed 18419881 ↗
  • Hogg 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. PubMed 18954287 ↗
  • Baraldo 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. PubMed 22868355 ↗
  • Barnes PJ, Celli BR. Systemic manifestations and comorbidities of COPD. Eur Respir J. 2009 May;33(5):1165-85. doi: 10.1183/09031936.00128008. PubMed 19407051 ↗
  • Rossi 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. PubMed 9230263 ↗
  • Gagnon 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. PubMed 24600216 ↗
  • Krieger 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. PubMed 19141987 ↗
  • Langer 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. PubMed 25159007 ↗
  • O'Donnell DE, Webb KA, Neder JA. Lung hyperinflation in COPD: applying physiology to clinical practice. COPD Res Pract. 2015;1(1):4
  • O'Donnell DE, Laveneziana P. Physiology and consequences of lung hyperinflation in COPD. Eur Respir Rev. 2006;15(100):61-67
  • Somfay 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. PubMed 11510809 ↗
  • Spahija 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. PubMed 20673034 ↗
  • Gigliotti 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. PubMed 12796152 ↗
  • Puente-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. PubMed 18044095 ↗
  • Ichiba 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. PubMed 30464362 ↗
  • Nozoe 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. PubMed 26982453 ↗
  • Mase 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. PubMed 29950772 ↗
  • Brunherotti 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. PubMed 23778773 ↗
  • Celli 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. PubMed 35914087 ↗
  • Pellegrino 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. PubMed 9042651 ↗
  • De Troyer A. Effect of hyperinflation on the diaphragm. Eur Respir J. 1997 Mar;10(3):708-13. PubMed 9073010 ↗
  • Decramer M. Hyperinflation and respiratory muscle interaction. Eur Respir J. 1997 Apr;10(4):934-41. PubMed 9150337 ↗
  • Munari 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. PubMed 33829946 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 25, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06519474
Lead sponsor
National Taiwan University Hospital
Responsible party
Sponsor
First posted
Jul 25, 2024
Start date
Jul 10, 2024
Primary completion
May 31, 2027 (estimated)
Completion
May 31, 2027 (estimated)
Last update
Jul 25, 2024

Study contacts

Yi Chun Chen
Contact
G00997@hch.gov.tw
+886-5326151 ext. 523504
Yi Chun Chen
Contact
jenchein@gmail.com
+886-961320509

Oversight

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

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