NCT06347549

Brief Summary

This is a cross-sectional obsessional study. This study aims (1) to investigate the relationship between sternocleidomastoid muscle recruitment and diaphragm thickness fraction during increasing inspiratory resistance in healthy adults; (2) to compare diaphragmatic and sternocleidomastoid muscle recruitment patterns with and without a standard diaphragmatic breathing instruction with increasing inspiratory resistance in healthy adults. Participants will be asked to breathe through a pressure threshold inspiratory loading device under different inspiratory resistances with and without a standard diaphragmatic breathing instruction. sternocleidomastoid muscle activity will be measured with surface electromyography, and diaphragm thickness will be assessed with ultrasonography.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2024

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

March 28, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 4, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

April 8, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 16, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 16, 2024

Completed
Last Updated

January 28, 2025

Status Verified

January 1, 2025

Enrollment Period

3 months

First QC Date

March 28, 2024

Last Update Submit

January 27, 2025

Conditions

Keywords

Diaphragmatic thickening fractionSternocleidomastoid musclesInspiratory pressures

Outcome Measures

Primary Outcomes (1)

  • Diaphragmatic thickening fraction

    Diaphragmatic thickening fraction is determined by "(thickness of the diaphragm at end inspiratory - thickness at end expiratory)/thickness at end expiratory". Diaphragmatic thickness will be measured by ultrasonography.

    Through study completion, an average of 1 year

Secondary Outcomes (2)

  • Muscle activation of the sternocleidomastoid muscle

    Through study completion, an average of 1 year

  • Perceived Exertion Borg scale

    Through study completion, an average of 1 year

Study Arms (1)

Healthy adults

Participants ≥18 years of age with normal health will be recruited in this study.

Diagnostic Test: Various intensities of inspiratory muscle training

Interventions

Each participant will be instructed to use a pressure threshold inspiratory loading device to perform, in random order, 10 breaths at an inspiratory intensity of 30%, 40%, 50%, 60%, 70%, and 80% of their maximum inspiratory pressure (MIP). A rest period of 15 minutes will be allowed between each inspiratory pressure set of 10 breaths. Simultaneous surface electromyographic (sEMG) recording of the right sternocleidomastoid muscle and ultrasound of right diaphragmatic thickness will be conducted during each breath. The entire recording procedure will be repeated on a separate day. During the repeat measurements, participants will be provided with specific breathing instruction to focus on the use of the diaphragm and to inhale air to the lower part of the chest.

Healthy adults

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy adults

You may qualify if:

  • Participants ≥18 years of age with normal health

You may not qualify if:

  • Pregnancy.
  • Participants with known cardiovascular, pulmonary, musculoskeletal or psychiatric disorders.
  • Participants with respiratory symptoms (from flu or other respiratory infection during the 2 weeks prior to measurements.
  • Participants can not cooperate the maximal inspiratory pressure measurement.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hong Kong Metropolitan University

Hong Kong, None Selected, China

Location

Study Officials

  • William Tsang

    Hong Kong Metropolitan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

March 28, 2024

First Posted

April 4, 2024

Study Start

April 8, 2024

Primary Completion

July 16, 2024

Study Completion

July 16, 2024

Last Updated

January 28, 2025

Record last verified: 2025-01

Locations