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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06347549
Other study ID # HE-SF2024/09
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 8, 2024
Est. completion date April 28, 2024

Study information

Verified date March 2024
Source Hong Kong Metropolitan University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Upon arrival at the laboratory, eligible participants will first perform a standard spirometry lung function test. The maximum inspiratory pressure (MIP) will be determined with a pressure threshold inspiratory loading device (POWERbreathe, K2). Each participant will then be instructed to use the device to perform, in random order, 10 breaths at an inspiratory intensity of 30%, 40%, 50%, 60%, 70%, and 80% 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. Practice trials will be conducted to ensure participant's understanding of diaphragmatic breathing.


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date April 28, 2024
Est. primary completion date April 25, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Participants =18 years of age with normal health Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Various intensities of inspiratory muscle training
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.

Locations

Country Name City State
China Hong Kong Metropolitan University Hong Kong None Selected

Sponsors (1)

Lead Sponsor Collaborator
Hong Kong Metropolitan University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Muscle activation of the sternocleidomastoid muscle Surface electromyography will be used to measure accessory inspiratory muscle (sternocleidomastoid muscles) activity during each inspiratory muscle training intensity. Through study completion, an average of 1 year
Secondary Perceived Exertion Borg scale This is a vertical scale quantified from 0 to 10, where 0 represents no symptoms, and 10 represents the maximum symptoms. The Borg score provides an individual measurement of the exercise intensity. Through study completion, an average of 1 year
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