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

NCT06267768 | Completed DMC

• 2 other identifiers: REC Reference No.:HE-OT2023/13Proj.Ref.No.: 2023/3007-R7052
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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

Keywords

Stroke; Diaphragmatic thickening fraction; Sternocleidomastoid muscles; Inspiratory pressures

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Muscle activation of the sternocleidomastoid muscle

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

• Perceived Exertion Borg scale

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

Study Arms (2)

Stroke participants

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

Diagnostic Test: Various intensities of inspiratory muscle training

Healthy participants

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

Diagnostic Test: Various intensities of inspiratory muscle training

Interventions

Various intensities of inspiratory muscle training 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; Stroke participants

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

People after stroke and healthy adults

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hong Kong Metropolitan University: lead
• Shenzhen Second People's Hospital: collaborator

Study Sites (1)

Shenzhen Second People's Hospital

Shenzhen, None Selected, China

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Tsang William

  Hong Kong Metropolitan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Study Record Dates

• First Submitted: February 4, 2024
• First Posted: February 20, 2024
• Study Start: March 2, 2024
• Primary Completion: August 17, 2024
• Study Completion: August 17, 2024
• Last Updated: January 28, 2025

Record last verified: 2025-01

Locations

CN (1)