NCT03729986

Brief Summary

Whether minimizing sternocleidomastoid (SCM) activation in supine position would increase diaphragm activation during loaded inspiratory muscle tests remains to be determined. Therefore, the purpose is to exam diaphragm and SCM activation during loaded inspiratory muscle tests in sitting and supine position in healthy adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2018

Shorter than P25 for all trials

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

November 1, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 5, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2018

Completed
Last Updated

February 12, 2019

Status Verified

November 1, 2018

Enrollment Period

2 months

First QC Date

November 1, 2018

Last Update Submit

February 10, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • Diaphragm and Sternocleidomastoid muscle activation

    Root mean square values during different conditions

    Through the completion of the loaded inspiratory muscle test condition; it would take about 3 minutes

  • 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 fatigability

    In one minute after the completion of the loaded inspiratory muscle test condition

Study Arms (1)

Healthy adults

Healthy subjects without exercise habit that can cooperate with the measurements of this study, loaded inspiratory muscle test.

Other: Loaded inspiratory muscle test

Interventions

Loaded inspiratory muscle tests will be set at 30% of maximal inspiratory pressure in sitting and supine positions. The orders of the two loaded test conditions will be conducted in random order with at least 20 minute 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.

Healthy adults

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy adults that are willing to cooperate the measurement of this study.

You may qualify if:

  • age \> 20 years old
  • without exercise habit (any exercise that less than 3 days/week)
  • 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
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2018

First Posted

November 5, 2018

Study Start

November 1, 2018

Primary Completion

December 28, 2018

Study Completion

December 28, 2018

Last Updated

February 12, 2019

Record last verified: 2018-11

Locations