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NCT Number: NCT06267768

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

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shenzhen Second People's Hospital

Shenzhen, None Selected, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Diaphragmatic thickening fraction

    Time frame: Data 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 outcomes

  1. Muscle activation of the sternocleidomastoid muscle

    Time frame: Data 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.

  2. Perceived Exertion Borg scale

    Time frame: Data 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.

Sponsors and collaborators

Lead sponsor

Hong Kong Metropolitan University

Other

Collaborators

  • Shenzhen Second People's Hospital

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 20, 2024
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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