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

NCT ID: NCT06267768

Last Updated: 2025-01-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 36 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-02
• Study Completion Date: 2024-08-17

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.

Conditions

Stroke

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Stroke participants

People diagnosed with stroke and meeting all inclusion criteria will be included in this study.

Various intensities of inspiratory muscle training

Intervention Type: DIAGNOSTIC_TEST

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.

Healthy participants

Healthy adults meeting all inclusion criteria will be included in this study.

Various intensities of inspiratory muscle training

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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.

• age ≥ 18 years.
• had not undergone thoracic or abdominal surgery.
• no previous history of respiratory problems.

Exclusion Criteria

• 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:

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shenzhen Second People's Hospital

OTHER

Sponsor Role: collaborator

Hong Kong Metropolitan University

OTHER

Sponsor Role: lead

Responsible Party

LIU FANG

PhD student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tsang William

Role: PRINCIPAL_INVESTIGATOR

Hong Kong Metropolitan University

Locations

Shenzhen Second People's Hospital

Shenzhen, None Selected, China

Countries

China

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Proj.Ref.No.: 2023/3007-R7052

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

REC Reference No.:HE-OT2023/13

Identifier Type: -

Identifier Source: org_study_id