NCT06519474

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

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
13mo left

Started Jul 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress63%
Jul 2024May 2027

Study Start

First participant enrolled

July 10, 2024

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

July 14, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 25, 2024

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2027

Last Updated

July 25, 2024

Status Verified

July 1, 2024

Enrollment Period

2.9 years

First QC Date

July 14, 2024

Last Update Submit

July 19, 2024

Conditions

Keywords

chronic obstructive pulmonary diseasedynamic hyperinflationelastic chest compressionfunctional exercise capacityrespiratory performance

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

EXPERIMENTAL

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

Lower chest compression

EXPERIMENTAL

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

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

Lower chest compressionUpper chest compression

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

RECRUITING

Related Publications (23)

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    PMID: 18419881BACKGROUND
  • 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.

    PMID: 18954287BACKGROUND
  • 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.

    PMID: 22868355BACKGROUND
  • Barnes PJ, Celli BR. Systemic manifestations and comorbidities of COPD. Eur Respir J. 2009 May;33(5):1165-85. doi: 10.1183/09031936.00128008.

    PMID: 19407051BACKGROUND
  • 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.

    PMID: 9230263BACKGROUND
  • 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.

    PMID: 24600216BACKGROUND
  • 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.

    PMID: 19141987BACKGROUND
  • 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.

    PMID: 25159007BACKGROUND
  • O'Donnell DE, Webb KA, Neder JA. Lung hyperinflation in COPD: applying physiology to clinical practice. COPD Res Pract. 2015;1(1):4

    BACKGROUND
  • O'Donnell DE, Laveneziana P. Physiology and consequences of lung hyperinflation in COPD. Eur Respir Rev. 2006;15(100):61-67

    BACKGROUND
  • 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.

    PMID: 11510809BACKGROUND
  • 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.

    PMID: 20673034BACKGROUND
  • 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.

    PMID: 12796152BACKGROUND
  • 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.

    PMID: 18044095BACKGROUND
  • 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.

    PMID: 30464362BACKGROUND
  • 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.

    PMID: 26982453BACKGROUND
  • 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.

    PMID: 29950772BACKGROUND
  • 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.

    PMID: 23778773BACKGROUND
  • 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.

    PMID: 35914087BACKGROUND
  • 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.

    PMID: 9042651BACKGROUND
  • De Troyer A. Effect of hyperinflation on the diaphragm. Eur Respir J. 1997 Mar;10(3):708-13.

    PMID: 9073010BACKGROUND
  • Decramer M. Hyperinflation and respiratory muscle interaction. Eur Respir J. 1997 Apr;10(4):934-41.

    PMID: 9150337BACKGROUND
  • 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.

    PMID: 33829946BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

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

Locations