NCT04316312

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 20, 2020

Completed
10 months until next milestone

Study Start

First participant enrolled

January 12, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

April 8, 2021

Status Verified

April 1, 2021

Enrollment Period

3 months

First QC Date

March 17, 2020

Last Update Submit

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

EXPERIMENTAL
Device: Threshold inspiratory muscle trainer

Interventions

Threshold inspiratory muscle trainer will be set between 15% to 30% of maximal inspiratory pressure.

Inspiratory muscle training group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

Study Officials

  • Li-Ying Wang, PhD

    National Taiwan University

    STUDY CHAIR

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

Locations