Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06347549
Other study ID # HE-SF2024/09
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 15, 2024
Est. completion date April 15, 2026

Study information

Verified date March 2024
Source Hong Kong Metropolitan University
Contact Fang LIU
Phone +8613603049475
Email s1350035@live.hkmu.edu.hk
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 Not yet recruiting
Enrollment 36
Est. completion date April 15, 2026
Est. primary completion date April 15, 2026
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
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hong Kong Metropolitan University

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
See also
  Status Clinical Trial Phase
Recruiting NCT03600207 - The Effect of Diaphragm Muscle Training on Chronic Low Back Pain N/A
Completed NCT02916342 - Interscalene Block Versus Combined Supraprascapular: Axillary Nerve Blocks Phase 4
Completed NCT02801058 - Ultrasound Evaluation of Changes in Diaphragm Induced by Osteopathic Manipulative Techniques N/A
Completed NCT03688724 - Perioperative Diaphragm Point of Care Ultrasound
Completed NCT04052230 - Evolution of Diaphragm Thickness Under Veno-arterial ECMO
Recruiting NCT03827538 - Endobronchial Valves Positioning Effects On Diaphragm Function In Patients With Lung Hyperinflation
Recruiting NCT05965830 - Comparing Electromyography of the Diaphragm With Ultrasound in Neonates and Children With Respiratory Support
Completed NCT06086769 - High Flow Oxygen Therapy Effect on Healthy Subjects N/A
Completed NCT03129386 - Defining the Normal Range for Maximal Sniff Diaphragm Thickening Fraction
Completed NCT05670327 - Diaphragmatic Ultrasound and Weaning After Lung Transplant.
Recruiting NCT06009731 - Diaphragmatic Speckle Tracking During Spontaneous Breathing Trial
Recruiting NCT01053182 - Esophagectomy Associated Respiratory Complications: Ivor-Lewis Versus Sweet Approaches Phase 3
Completed NCT04333186 - Expiratory Muscle Function in Critically Ill Ventilated Patients
Recruiting NCT05529641 - Effects of Diaphragmatic Resistance Training in People With Chronic Neck Pain. N/A
Completed NCT02725190 - Effects of Sleep Deprivation on Diaphragm Command During an Inspiratory Endurance Trial in Healthy Volunteers. N/A
Recruiting NCT03114384 - Patient-ventilator Asynchrony During Noninvasive Ventilation Assessed Using Diaphragm Ultrasonography N/A
Recruiting NCT06339632 - Effects of Transcutaneous Electrical Phrenic Nerve Stimulation and Transcutaneous Electrical Diaphragmatic Stimulation N/A
Not yet recruiting NCT06348745 - Trans Thoracic Ultrasound to Assess Diaphragmatic Function in Stable COPD Versus Bronchial Asthma. N/A