- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03522376
Inspiratory Muscle Activation Patterns in Patients With Chronic Obstructive Pulmonary Disease
Diaphragm and Sternocleidomastoid Muscle Activation Patterns During Different Loaded Inspiratory Muscle Performance in Patients With Chronic Obstructive Pulmonary Disease
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The prevalence of chronic obstructive pulmonary disease (COPD) is 11.7% around the world in 2010, and it is expected to rise over the next 30 years. COPD is a chronic inflammatory lung disease that causes obstructed airflow from the lung, characterized by chronic cough, dyspnea, and sputum production. Studies have found evidences of inspiratory muscle weakness in patients with COPD which include a reduction in maximal inspiratory pressure (PImax), a shift toward oxidative type I fibers and atrophy in all types of fibers in diaphragm muscle. The shift of diaphragm muscle fiber toward oxidative type I fibers might result from endurance training-like effect that served to counteract the negative effects of elevated oxidative stress and systemic inflammation in patients with COPD.
Inspiratory muscle training (IMT) is commonly applied to patients with COPD during pulmonary rehabilitation, but its clinical benefits remain inconclusive. Some studies showed that IMT improves breathing pattern, dyspnea and the strength and endurance of diaphragm, while others showed that IMT could not improve inspiratory muscle strength and functional exercise capacity either applied alone or in addition to pulmonary rehabilitation in patients with COPD. Evidence from animal study showed that overloading the diaphragm during resistive breathing might induce acute diaphragm injury. Increases oxidative stress and systemic inflammation, and exacerbating the apoptosis of the diaphragm fibers may also occur during IMT in patients with COPD, which leads to the progression of diaphragm muscle fibers atrophy. In human studies, the intensity used for IMT ranged from 10% to 70% of PImax, and the training effect showed no clear dose-response pattern. The optimal intensity that would induce positive physiological effect without eliciting overloading injury remains unclear. In healthy adults, the accessory muscles, such as sternocleidomastoid (SCM), scalenes, and intercostals muscle, would be recruited to assist ventilation with increasing ventilatory demand. Thus the activation of accessory muscles could be an indicator for training overload. However, the activation pattern of accessory muscle has not been studied in patients with COPD during IMT. Whether the commonly prescribed intensity for IMT would lead to excessive activation of diaphragm, and more accessory muscle recruitment in patients with COPD remains to be determined. Therefore, the purpose of this study is to exam diaphragm and SCM muscle activation using surface electromyography during loaded inspiratory muscle tests with 30% and 50% of PImax intensity.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Zhongzheng Dist
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Taipei, Zhongzheng Dist, Taiwan, 100
- School and Graduate Institute of Physical Therapy of National Taiwan University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- age > 20 years old
- has been diagnosis of chronic obstructive pulmonary disease with stable clinical condition with no infection or acute exacerbation in the previous four weeks
- can cooperate with the measurements of this study
Exclusion Criteria:
- any clinical diagnosis that will influence the measurement, including any history of neuromyopathy
- angina, acute myocardial infarction in the previous one month
- pregnancy
- participated in inspiratory muscle training program in the previous three months
- any psychiatric or cognitive disorders, for example: Mini-Mental State Examination (MMSE) < 24, that will disturb the communication and cooperation of the study
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Chronic obstructive pulmonary disease
Subjects with the diagnosis of chronic obstructive pulmonary disease, stable clinically, has no infection or acute exacerbation in the previous four weeks, and can cooperate with the measurements of this study, loaded inspiratory muscle test.
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Loaded inspiratory muscle tests will be set at 30% and 50% of maximal inspiratory pressure.
The orders of the two loaded test conditions will be conducted in random order with at least 24 hours separation.
This is an observational study.
Subjects will perform only 15 breaths with each loaded test condition to exam the performance of their inspiratory muscles.
Loaded inspiratory muscle test is not for training.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The mean median frequency of diaphragm and sternocleidomastoid muscle
Time Frame: In one minute after the completion of the loaded inspiratory muscle test condition
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The power spectrum is divided into two equal areas of the frequency value by median frequency to exam muscle fatigability
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In one minute after the completion of the loaded inspiratory muscle test condition
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Diaphragm and Sternocleidomastoid muscle activation
Time Frame: through the completion of the loaded inspiratory muscle test condition; it would take about 3 minutes
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Root mean square values during different conditions
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through the completion of the loaded inspiratory muscle test condition; it would take about 3 minutes
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201802054RINB
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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