- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06347549
The Impact of Diaphragmatic Breathing Instructions and Inspiratory Pressures on Diaphragm Contraction in Healthy Adults
Diaphragmatic and Sternocleidomastoid Muscle Recruitment at Various Inspiratory Loads With and Without Breathing Instruction in Healthy Adults
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Fang LIU
- Phone Number: +8613603049475
- Email: s1350035@live.hkmu.edu.hk
Study Contact Backup
- Name: William Tsang
- Phone Number: (852) 39708703
- Email: wntsang@hkmu.edu.hk
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Healthy adults
Participants ≥18 years of age with normal health will be recruited in this study.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diaphragmatic thickening fraction
Time Frame: Through study completion, an average of 1 year
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle activation of the sternocleidomastoid muscle
Time Frame: Through study completion, an average of 1 year
|
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
|
Perceived Exertion Borg scale
Time Frame: Through study completion, an average of 1 year
|
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
|
Collaborators and Investigators
Investigators
- Principal Investigator: William Tsang, Hong Kong Metropolitan University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HE-SF2024/09
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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