Clinical trial NCT06267768: The Effects of Inspiratory Pressures on Diaphragmatic Contraction in People After Stroke
Official title: The Effects of Different Inspiratory Pressures on the Diaphragmatic Thickness Fraction and Sternocleidomastoid Muscle Activation in People After Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: Stroke
Diaphragmatic thickening fraction
Sternocleidomastoid muscles
Inspiratory pressures
Lead sponsor: Hong Kong Metropolitan University
Sponsor class: OTHER
Collaborators: name: Shenzhen Second People's Hospital
First posted: 2024-02-20
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: People after stroke and healthy adults

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.


Eligibility 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 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.

Primary outcomes:
measure: Diaphragmatic thickening fraction
timeFrame: Data will be measured at baseline and at the end of each inspiratory muscle training intensity protocol;
Secondary outcomes:
measure: Muscle activation of the sternocleidomastoid muscle
timeFrame: Data will be measured at baseline and at the end of each inspiratory muscle training intensity protocol;
measure: Perceived Exertion Borg scale
timeFrame: Data will be measured at the end of each inspiratory muscle training intensity protocol;
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen Second People's Hospital
state: None Selected
Study officials:
affiliation: Hong Kong Metropolitan University
name: Tsang William
role: PRINCIPAL_INVESTIGATOR
References: