The Inspiratory Muscle Activation Pattern and Training Efficacy in Patients With Chronic Obstructive Pulmonary Disease After Acute Exacerbation
Primary Purpose
Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Threshold inspiratory muscle trainer
Sponsored by
About this trial
This is an interventional treatment trial for Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Eligibility Criteria
Inclusion Criteria:
- age > 20 years old
- has been diagnosis of chronic obstructive pulmonary disease and experienced at least 2 times of acute exacerbation in recent 6 months
- 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
Sites / Locations
- School and Graduate Institute of Physical Therapy of National Taiwan University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Inspiratory muscle training group
Arm Description
Outcomes
Primary Outcome Measures
Diaphragm and Sternocleidomastoid muscle activation
The surface electromyography (EMG) signal was analyzed in the time domain, calculating root mean square (RMS) amplitude with a time constant of 30 mini seconds. A 1.5 seconds window of diaphragm and SCM muscle signals at peak pressure during maximal inspiratory pressure test were obtained and calculated as maximal effort. Diaphragm and SCM activation were calculated using mean RMS values of each threshold loaded breathing test, and then normalized to maximal effort (%EMGDia and %EMGSCM).
Secondary Outcome Measures
The mean median frequency of diaphragm and sternocleidomastoid muscle
The power spectrum is divided into two equal areas of the frequency value by median frequency to exam muscle fatigue.
Full Information
NCT ID
NCT04316312
First Posted
March 17, 2020
Last Updated
April 6, 2021
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04316312
Brief Title
The Inspiratory Muscle Activation Pattern and Training Efficacy in Patients With Chronic Obstructive Pulmonary Disease After Acute Exacerbation
Official Title
The Inspiratory Muscle Activation Pattern and Training Efficacy in Patients With Chronic Obstructive Pulmonary Disease After Acute Exacerbation
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
January 12, 2021 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
March 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of this study is to assess the activation patterns of diaphragm and sternocleidomastoid (SCM) muscle during different loaded inspiratory muscle performance in patients with COPD after acute exacerbation. Null hypothesis (H0): There is no significant difference between activation pattern of diaphragm and SCM muscle during different loaded inspiratory muscle performance in patients with COPD after acute exacerbation. Alternative hypothesis (H1): There is significant difference between activation pattern of diaphragm and SCM muscle during different loaded inspiratory muscle performance in patients with COPD after acute exacerbation.
Detailed Description
The prevalence of chronic obstructive pulmonary disease (COPD) is 11.7% around the world, and it is expected to rise over the next 30 years. In Taiwan, COPD is estimated as the seventh leading cause of death in 2016, and has been gradually increasing in the past decades. COPD has been long considered to be a disease state characterized by airflow limitation that are not fully reversible, leading to abnormalities in control of breathing, worsening of respiratory mechanics and pulmonary function. However, COPD is no longer considered to affect only the lungs and airways, but also the rest of the body including decreases in respiratory and limb-muscle mass and function. When acute exacerbation occurs, lung function decreases rapidly. According to the previous studies, inspiratory muscle training (IMT), can improve the strength and endurance of the diaphragm, reduce dyspnea and breathing pattern, thus increasing the capacity of activities tolerance in patients with COPD. Although more and more studies are focus on diaphragm weakness and the effect of IMT in patients with COPD, the efficacy and intensity of IMT in patients with COPD is still controversial and the clinical use is limited. Whether increases intensity during IMT would lead to improvements in contraction pattern of respiratory muscle remained unclear. Therefore, the purpose of this study is to assess the activation patterns of diaphragm and sternocleidomastoid (SCM) muscle during different loaded inspiratory muscle performance in patients with COPD after acute exacerbation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Exacerbation of Chronic Obstructive Pulmonary Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Inspiratory muscle training group
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Threshold inspiratory muscle trainer
Intervention Description
Threshold inspiratory muscle trainer will be set between 15% to 30% of maximal inspiratory pressure.
Primary Outcome Measure Information:
Title
Diaphragm and Sternocleidomastoid muscle activation
Description
The surface electromyography (EMG) signal was analyzed in the time domain, calculating root mean square (RMS) amplitude with a time constant of 30 mini seconds. A 1.5 seconds window of diaphragm and SCM muscle signals at peak pressure during maximal inspiratory pressure test were obtained and calculated as maximal effort. Diaphragm and SCM activation were calculated using mean RMS values of each threshold loaded breathing test, and then normalized to maximal effort (%EMGDia and %EMGSCM).
Time Frame
through the completion of the maximal inspiratory pressure test and loaded inspiratory muscle test condition; totally it would take about 3 minutes
Secondary Outcome Measure Information:
Title
The mean median frequency of diaphragm and sternocleidomastoid muscle
Description
The power spectrum is divided into two equal areas of the frequency value by median frequency to exam muscle fatigue.
Time Frame
In one minute after the completion of the loaded inspiratory muscle test condition
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age > 20 years old
has been diagnosis of chronic obstructive pulmonary disease and experienced at least 2 times of acute exacerbation in recent 6 months
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li-Ying Wang, PhD
Organizational Affiliation
National Taiwan University
Official's Role
Study Chair
Facility Information:
Facility Name
School and Graduate Institute of Physical Therapy of National Taiwan University
City
Taipei
State/Province
Zhongzheng Dist
ZIP/Postal Code
100
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
The Inspiratory Muscle Activation Pattern and Training Efficacy in Patients With Chronic Obstructive Pulmonary Disease After Acute Exacerbation
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