The Effects of Inspiratory Pressures on Diaphragmatic Contraction in People After Stroke

Stroke Clinical Trial

Official title:

The Effects of Different Inspiratory Pressures on the Diaphragmatic Thickness Fraction and Sternocleidomastoid Muscle Activation in People After Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06267768
• Other study ID #: REC Reference No.:HE-OT2023/13
• Secondary ID: Proj.Ref.No.: 20
• Status: Recruiting
• Start date: June 1, 2024
• Est. completion date: November 30, 2025

Study information

• Verified date: February 2024
• Source: Hong Kong Metropolitan University
• Contact: Fang LIU
• Phone: +8613603049475
• Email: s1350035[@]live.hkmu.edu.hk
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This is a cross-sectional study to determine the optimal inspiratory muscle training (IMT) intensity for stroke survivors. Participants will breathe through a pressure threshold inspiratory loading device with varying loads in random order. Each IMT intensity protocol consists of 10 breaths. During the test, accessory inspiratory muscle activity will be measured with surface electromyography (sEMG) and diaphragm thickness will be used to assessed with ultrasonography. Repeated-measures ANOVA will be used for statistical analysis to determine the most effective training intensity for future study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: November 30, 2025
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Recruitment of participants after a stroke:

The inclusion criteria are:

• clinical diagnosis of ischemic and/or hemorrhagic stroke.

• age = 18 years.

• duration of stroke ranges from 1 month to 12 months after diagnosis.

• had no facial palsy, which could prevent proper labial occlusion.

• had not undergone thoracic or abdominal surgery.

• could understand and follow the verbal instruction.

• stable cardiac conditions.

• no previous history of respiratory problems.

The exclusion criteria are:

• acute myocardial infarction or acute heart failure.

• acute pain on chest or abdominal.

• with the clinical signs of significant pulmonary disease.

• consciousness impaired.

• patient with nasal feeding tube, tracheal tube and/or any condition, which prevent the measurement or training.

Recruitment of healthy participants:

The inclusion criteria are:

• age = 18 years.

• had not undergone thoracic or abdominal surgery.

• no previous history of respiratory problems.

The exclusion criteria are:

• acute myocardial infarction or acute heart failure.

• acute pain in the chest or abdominal.

• with the clinical signs of significant pulmonary disease.

• unstable hypertension, arrhythmias, or unstable cardiovascular conditions, such as fluctuations in blood pressure and heart rate, indicate poor cardiac prognosis or the need for vasopressor medications.

• pregnant.

Related Conditions & MeSH terms

• Respiratory Aspiration
• Stroke

Intervention

Diagnostic Test:
• Various intensities of inspiratory muscle training
Each participant will be asked to perform the lung function test to measure the maximal inspiratory pressure (MIP) after including the study. After the baseline measurement, all participants will be requested to use a nose clip to hold the nose and breathe with the mouth through a pressure threshold inspiratory loading device (POWERbreathe, KH2, England). The inspiratory pressure will be set at 30%, 40%, 50%, 60%, 70%, or 80% of their MIP, in random order. Each MIP intensity protocol consists of 10 breaths. Resting will be allowed between different protocols of contraction intensity (% MIP). During the test, sternocleidomastoid muscle activity will be measured with surface electromyography (sEMG) and diaphragm thickness will be used to assessed with ultrasonography.

Locations

Country	Name	City	State
China	Shenzhen Second People's Hospital	Shenzhen	None Selected

Sponsors (2)

Lead Sponsor	Collaborator
Hong Kong Metropolitan University	Shenzhen Second People's Hospital

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.	Data will be measured at baseline and at the end of each inspiratory muscle training intensity protocol;
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 protocol.	Data will be measured at baseline and at the end of each inspiratory muscle training intensity protocol;
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.	Data will be measured at the end of each inspiratory muscle training intensity protocol;