The Inspiratory Muscle Activation Pattern and Training Efficacy in Patients With Chronic Obstructive Pulmonary Disease After Acute Exacerbation
1 other identifier
interventional
1
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 17, 2020
CompletedFirst Posted
Study publicly available on registry
March 20, 2020
CompletedStudy Start
First participant enrolled
January 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2021
CompletedApril 8, 2021
April 1, 2021
3 months
March 17, 2020
April 6, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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).
through the completion of the maximal inspiratory pressure test and loaded inspiratory muscle test condition; totally it would take about 3 minutes
Secondary Outcomes (1)
The mean median frequency of diaphragm and sternocleidomastoid muscle
In one minute after the completion of the loaded inspiratory muscle test condition
Study Arms (1)
Inspiratory muscle training group
EXPERIMENTALInterventions
Threshold inspiratory muscle trainer will be set between 15% to 30% of maximal inspiratory pressure.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
School and Graduate Institute of Physical Therapy of National Taiwan University
Taipei, Zhongzheng Dist, 100, Taiwan
Study Officials
- STUDY CHAIR
Li-Ying Wang, PhD
National Taiwan University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 17, 2020
First Posted
March 20, 2020
Study Start
January 12, 2021
Primary Completion
March 31, 2021
Study Completion
March 31, 2021
Last Updated
April 8, 2021
Record last verified: 2021-04