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Inspiratory Muscle Activation Patterns in Patients With Chronic Obstructive Pulmonary Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03522376
Recruitment Status : Completed
First Posted : May 11, 2018
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:
Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory lung disease that causes obstructed airflow from the lung, characterized by chronic cough, dyspnea, and sputum production. Inspiratory muscle weakness has been shown in patients with COPD, and inspiratory muscle training (IMT) is commonly applied to these patients. However, the optimal prescribed intensity of IMT for patients with COPD remains unclear. In healthy adults the accessory muscles would be recruited to assist ventilation with increasing ventilatory demand, but the activation pattern of accessory muscles has not been studied in patients with COPD during loaded condition such as IMT. Therefore, the purpose of this study is to exam diaphragm and sternocleidomastoid muscle activation using surface electromyography during loaded inspiratory muscle tests with intensity of 30% and 50% of maximal inspiratory pressure.

Condition or disease Intervention/treatment
Chronic Obstructive Pulmonary Disease Other: Loaded inspiratory muscle test

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.

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Diaphragm and Sternocleidomastoid Muscle Activation Patterns During Different Loaded Inspiratory Muscle Performance in Patients With Chronic Obstructive Pulmonary Disease
Actual Study Start Date : April 24, 2018
Actual Primary Completion Date : December 20, 2018
Actual Study Completion Date : December 20, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Group/Cohort Intervention/treatment
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.
Other: Loaded inspiratory muscle test
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.




Primary Outcome Measures :
  1. Diaphragm and Sternocleidomastoid muscle activation [ Time Frame: through the completion of the loaded inspiratory muscle test condition; it would take about 3 minutes ]
    Root mean square values during different conditions

  2. The mean median frequency of diaphragm and sternocleidomastoid muscle [ Time Frame: In one minute after the completion of the loaded inspiratory muscle test condition ]
    The power spectrum is divided into two equal areas of the frequency value by median frequency to exam muscle fatigability



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Chronic obstructive pulmonary disease is a chronic inflammatory lung disease that causes obstructed airflow from the lung, characterized by chronic cough, dyspnea, and sputum production. Recent studies show that other than respiratory symptoms, patients with chronic obstructive pulmonary disease often present with inspiratory muscle weakness.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03522376


Locations
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Taiwan
School and Graduate Institute of Physical Therapy of National Taiwan University
Taipei, Zhongzheng Dist, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Study Chair: Li-Ying Wang, Phd National Taiwan University
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03522376    
Other Study ID Numbers: 201802054RINB
First Posted: May 11, 2018    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases