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Recruiting NCT06519474

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

No phase Interventional COPD Hyperinflation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Theraband chest compression.
Who it may be relevant to
Registry conditions: COPD, Hyperinflation. Basic parameters: from 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

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.

Interventions

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

Primary outcome measures

  • Functional exercise capacity [Time frame: up to 3 weeks]
  • Respiratory muscle performance [Time frame: up to 3 weeks]
  • Respiratory flow performance [Time frame: up to 3 weeks]

Eligibility criteria

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

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Treatment

Study locations

Taiwan · 1 center
  • National Taiwan University Hospital Hsinchu Branch — Hsinchu

Publications

  • Hogg JC. Lung structure and function in COPD. Int J Tuberc Lung Dis. 2008 May;12(5):467-79. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 25159007

Identifiers

NCT: NCT06519474 · 202405096RINE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗