StrokeNCT06267768
The Effects of Inspiratory Pressures on Diaphragmatic Contraction in People After Stroke
An observational study of Stroke, run by Hong Kong Metropolitan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Various intensities of inspiratory muscle training
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 2 Mar 2024to 17 Aug 2024
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: People after stroke and healthy adults
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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Different Inspiratory Pressures on the Diaphragmatic Thickness Fraction and Sternocleidomastoid Muscle Activation 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.
- Conditions
- Stroke
- Being tested
- Various intensities of inspiratory muscle training
- Keywords
- Stroke, Diaphragmatic thickening fraction, Sternocleidomastoid muscles, Inspiratory pressures
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Various intensities of inspiratory muscle trainingDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Stroke participants | People diagnosed with stroke and meeting all inclusion criteria will be included in this study. Receives: Diagnostic Test: Various intensities of inspiratory muscle training | |
| Healthy participants | Healthy adults meeting all inclusion criteria will be included in this study. Receives: Diagnostic Test: Various intensities of inspiratory muscle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Surface electromyography will be used to measure accessory inspiratory muscle (sternocleidomastoid muscles) activity during each inspiratory muscle training intensity protocol.
Measured: Data will be measured at baseline and at the end of each inspiratory muscle training intensity protocol;
Perceived Exertion Borg scale
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.
Measured: Data will be measured at the end of each inspiratory muscle training intensity protocol;
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start2 Mar 2024
- Primary completion17 Aug 2024
- Study completion17 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 36 participants (actual)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Hong Kong Metropolitan University
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen Second People's Hospital
- Responsible party
- Principal investigator, LIU FANG, Hong Kong Metropolitan University
- Investigators
- Tsang William, Principal investigator, Hong Kong Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06267768
- Sponsor's protocol ID
- REC Reference No.:HE-OT2023/13
- Other IDs
- Proj.Ref.No.: 2023/3007-R7052
- Status last verified
- Jan 2025
- First submitted
- 4 Feb 2024
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Liu F, Jones AYM, Tsang RCC, Yam TTT, Tsang WWN. Diaphragm and sternocleidomastoid muscle activity with increasing inspiratory pressure loads in people after stroke. Sci Rep. 2025 Feb 18;15(1):5856. doi: 10.1038/s41598-025-90199-6.
PubMed 39966532
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Different Inspiratory Pressures on the Diaphragmatic Thickness Fraction and Sternocleidomastoid Muscle Activation in People After Stroke
- ClinicalTrials.gov ID
- NCT06267768
- Acronym / sponsor ID
- REC Reference No.:HE-OT2023/13
- Conditions
- Stroke
- Keywords
- Stroke, Diaphragmatic thickening fraction, Sternocleidomastoid muscles, Inspiratory pressures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Hong Kong Metropolitan UniversityUniversity, hospital or other
- Collaborators
- Shenzhen Second People's Hospital
- Study start
- 2 Mar 2024 (actual)
- Primary completion
- 17 Aug 2024 (actual)
- Study completion
- 17 Aug 2024 (actual)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 7 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stroke participants | – | Diagnostic Test: Various intensities of inspiratory muscle trainingPeople diagnosed with stroke and meeting all inclusion criteria will be included in this study. |
| Healthy participants | – | Diagnostic Test: Various intensities of inspiratory muscle trainingHealthy adults meeting all inclusion criteria will be included in this study. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People after stroke and healthy adults
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Various intensities of inspiratory muscle trainingEach 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. | Diagnostic test | Healthy participants, Stroke participants |
Primary outcome
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.
2 secondary outcomes
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;
Perceived Exertion Borg scale
Time frame: Data will be measured at the end of each inspiratory muscle training intensity protocol;
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Derived from this study: PubMed 39966532Liu F, Jones AYM, Tsang RCC, Yam TTT, Tsang WWN. Diaphragm and sternocleidomastoid muscle activity with increasing inspiratory pressure loads in people after stroke. Sci Rep. 2025 Feb 18;15(1):5856. doi: 10.1038/s41598-025-90199-6.
- Individual participant dataSharing planned: Undecided
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tsang William principal investigator
Hong Kong Metropolitan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Hong Kong Metropolitan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diaphragmatic thickening fraction (time frame: Data will be measured at baseline and at the end of each inspiratory muscle training intensity protocol;). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06267768, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.