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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06267768
Enrollment
36
Registered
2024-02-20
Start date
2024-03-02
Completion date
2024-08-17
Last updated
2025-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Stroke, Diaphragmatic thickening fraction, Sternocleidomastoid muscles, Inspiratory pressures

Brief 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.

Interventions

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.

Sponsors

Shenzhen Second People's Hospital
CollaboratorOTHER
Hong Kong Metropolitan University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Diaphragmatic thickening fractionData will be measured at baseline and at the end of each inspiratory muscle training intensity protocol;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.

Secondary

MeasureTime frameDescription
Muscle activation of the sternocleidomastoid muscleData will be measured at baseline and at the end of each inspiratory muscle training intensity protocol;Surface electromyography will be used to measure accessory inspiratory muscle (sternocleidomastoid muscles) activity during each inspiratory muscle training intensity protocol.
Perceived Exertion Borg scaleData will be measured at the end of each inspiratory muscle training intensity protocol;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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026