COPDNCT06519474
Effect of Elastic Chest Compression on Functional Exercise Capacity and Respiratory Performance in Patients With COPD
A study testing Theraband chest compression in people with COPD and Hyperinflation, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- COPD, Hyperinflation
- What is being tested?
- Theraband chest compression
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Jul 2024to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital Hsinchu Branch
Hsinchu
Yi Chun Chen, +886-3526151 ext. 523504, G00997@hch.gov.tw
Yi Chun Chen, +886-961320509 ext. 523504, jenchein@gmail.com
About this study
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?
Read more
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.
- Conditions
- COPD, Hyperinflation
- Being tested
- Theraband chest compression
- Keywords
- chronic obstructive pulmonary disease, dynamic hyperinflation, elastic chest compression, functional exercise capacity, respiratory performance
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Theraband chest compressionDevice
Chest compression applicated via a Red Theraband over the upper or lower chest region
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Theraband chest compression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional exercise capacity
6 minute walk test measured in meters
Measured: up to 3 weeks
Respiratory muscle performance
Maximum inspiratory (MIP) and expiratory pressures (MEP) in mmH2O
Measured: up to 3 weeks
Respiratory flow performance
peak inspiratory (PIFR) and expiratory flows (PEFR) in liter per minute
Measured: up to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start10 Jul 2024
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06519474
- Sponsor's protocol ID
- 202405096RINE
- Status last verified
- Jul 2024
- First submitted
- 14 Jul 2024
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hogg JC. Lung structure and function in COPD. Int J Tuberc Lung Dis. 2008 May;12(5):467-79.
PubMed 18419881Hogg 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 18954287Baraldo 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 22868355Barnes PJ, Celli BR. Systemic manifestations and comorbidities of COPD. Eur Respir J. 2009 May;33(5):1165-85. doi: 10.1183/09031936.00128008.
PubMed 19407051Rossi 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 9230263Gagnon 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 24600216Krieger 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 19141987Langer 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 25159007O'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 11510809Spahija 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 20673034Gigliotti 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 12796152Puente-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 18044095Ichiba 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Elastic Chest Compression on Functional Exercise Capacity and Respiratory Performance in Patients With COPD
- ClinicalTrials.gov ID
- NCT06519474
- Acronym / sponsor ID
- 202405096RINE
- Conditions
- COPD, Hyperinflation
- Keywords
- chronic obstructive pulmonary disease, dynamic hyperinflation, elastic chest compression, functional exercise capacity, respiratory performance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 10 Jul 2024 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 25 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Upper chest compression | Experimental | Device: Theraband chest compressionThe 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 | Experimental | Device: Theraband chest compressionThe 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Theraband chest compressionChest compression applicated via a Red Theraband over the upper or lower chest region | Device | Lower chest compression, Upper chest compression |
Primary outcome
Functional exercise capacity
Time frame: up to 3 weeks
6 minute walk test measured in meters
Respiratory muscle performance
Time frame: up to 3 weeks
Maximum inspiratory (MIP) and expiratory pressures (MEP) in mmH2O
Respiratory flow performance
Time frame: up to 3 weeks
peak inspiratory (PIFR) and expiratory flows (PEFR) in liter per minute
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- Background: PubMed 18419881Hogg JC. Lung structure and function in COPD. Int J Tuberc Lung Dis. 2008 May;12(5):467-79.
- Background: PubMed 18954287Hogg 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.
- Background: PubMed 22868355Baraldo 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.
- Background: PubMed 19407051Barnes PJ, Celli BR. Systemic manifestations and comorbidities of COPD. Eur Respir J. 2009 May;33(5):1165-85. doi: 10.1183/09031936.00128008.
- Background: PubMed 9230263Rossi 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.
- Background: PubMed 24600216Gagnon 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.
- Background: PubMed 19141987Krieger 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.
- Background: PubMed 25159007Langer 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.
- BackgroundO'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
- Background: PubMed 11510809Somfay 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.
- Background: PubMed 20673034Spahija 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Theraband chest compression in people with COPD and Hyperinflation, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi Chun Chen (+886-5326151 ext. 523504, G00997@hch.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional exercise capacity (time frame: up to 3 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06519474, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2024.