StrokeNCT06447272
Effects of IMT on Respiratory, Diaphragmatic and Balance Functions, Exercise Capacity and QOL in People After Stroke
A study testing target inspiratory muscle training in people with Stroke, run by Hong Kong Metropolitan University.
Trial summary
This is a randomized controlled trial. This current RCT study will be a continuing project based on the optimal IMT intensity identified from our ongoing study. This ongoing study (registered on ClinicalTrials.gov with the registration number NCT06267768) aims to explore the optimal IMT intensity for the recruitment… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- target inspiratory muscle training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2025to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged between 40 and 80 years;
- breathing spontaneously;
- clinically diagnosed with ischemic and/or haemorrhagic stroke;
- stroke duration from onset between 1 and 12 months;
- no history of thoracic or abdominal surgery within the last 6 months;
- able to understand and follow verbal instructions;
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- no facial palsy, or mild facial palsy without limitation of labial occlusion;
- capable of maintaining a resting sitting posture without feet support for at least 30 seconds;
- no cognitive impairment, as indicated by a Montreal Cognitive Assessment (MoCA) score of ≥ 26;
- able to independently walk at least 10 meters with or without an assistive device.
Who cannot join
- acute myocardial infarction or acute heart failure;
- acute pain in any part of the body;
- with respiratory illness or positive clinical signs of impaired respiratory function, such as shortness of breath, hypoxemia, chronic cough, or sputum retention;
- with chronic cardiovascular dysfunction;
- Trunk Impairment Scale (TIS) score ≥ 20;
- presence of a nasal feeding tube, tracheal tube, or any condition that prevents the measurement or implementation of the study procedure.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
William Wai Nam Tsang contact
About this study
Official title: Effects of Inspiratory Muscle Training on Respiratory and Diaphragmatic Functions, Balance Control, Exercise Capacity and Quality of Life in People After Stroke: a Randomized Controlled Trial
This is a randomized controlled trial. This current RCT study will be a continuing project based on the optimal IMT intensity identified from our ongoing study. This ongoing study (registered on ClinicalTrials.gov with the registration number NCT06267768) aims to explore the optimal IMT intensity for the recruitment of diaphragm muscles in people after a stroke. Based on this intensity, the aim of this RCT is to explore the effects of a 4-week protocol of IMT on respiratory function, balance control, exercise capacity, and quality of life in people after a stroke.
- Conditions
- Stroke
- Being tested
- sham inspiratory muscle training, target inspiratory muscle training
- Keywords
- Stroke, Inspiratory muscle training, Diaphragm, Balance control, Exercise capacity
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sham inspiratory muscle trainingOther
This group will receive conventional treatment + sham IMT (with 10% MIP as the training intensity)
target inspiratory muscle trainingOther
This group will receive conventional treatment + target IMT (the IMT identified as optimal intensity based on the results of our undergoing study).
| Study group | Role | What they receive |
|---|---|---|
| Sham IMT | Sham comparator | conventional treatment + sham IMT Receives: Other: sham inspiratory muscle training |
| Target IMT | Experimental | conventional treatment + target IMT Receives: Other: target inspiratory muscle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragmatic thickness
The diaphragmatic thickness of both the left and right diaphragms will be measured by ultrasound. (Mindray M9, Shenzhen, China).
Measured: baseline, after 4 weeks of intervention
Secondary outcomes (9)
Forced Vital Capacity (FVC)
Forced Vital Capacity (FVC) is a measurement used in pulmonary function tests to assess lung function. It refers to the total volume of air that a person can forcibly exhale from their lungs after taking the deepest breath possible. It will be measured using the spirometer.
Measured: baseline, after 4 weeks of intervention
Forced Expiratory Volume in one second (FEV1)
Forced Expiratory Volume in one second (FEV1) measures the volume of air a person can forcibly exhale in the first second of a forced breath. It will be measured using the spirometer.
Measured: baseline, after 4 weeks of intervention
Maximum Inspiratory Pressure (MIP)
Maximum Inspiratory Pressure (MIP) is a measure used in pulmonary function testing to assess the strength of the respiratory muscles, particularly the muscles used for inhalation. It will be measured using the spirometer.
Measured: baseline, after 4 weeks of intervention
Trunk Impairment Scale (TIS)
The TIS is a rating scale used to measure static sitting balance, dynamic sitting balance, and trunk coordination. The total TIS score ranges from 0 to 23 points, with a higher score indicating better trunk function.
Measured: baseline, after 4 weeks of intervention
Sitting Balance
A force plate will be used to measure changes in the center of pressure during the performance of various tasks in sitting positions.
Measured: baseline, after 4 weeks of intervention
Timed Up and Go Test (TUG)
TUG is a test to measure the time that a participant needs to stand up from a standard armchair, walk a short distance of about 3 meters, turn around, walk back to the chair, and sit down again.
Measured: baseline, after 4 weeks of intervention
Falls efficacy scale international
The Falls Efficacy Scale-International (FES-I) is a questionnaire measuring fear of falling in older adults. It consists of 16 items, each scored from 1 to 4, with higher scores indicating greater fear. The total score ranges from 16 (lowest fear) to 64 (highest fear). It is used in clinical settings to assess fall risk and tailor interventions.
Measured: baseline, after 4 weeks of intervention, 12-week follow-up after the end of intervention
6-Minute Walk Test
The 6-Minute Walk Test (6MWT) measures how far someone can walk in six minutes. It assesses exercise capacity and mobility.
Measured: baseline, after 4 weeks of intervention
Stroke Impact Scale
The Chinese version of the Stroke Impact Scale 3.0 (SIS) will be used to measure the quality of life. Scores range from 0 to 100, a higher overall score suggests better physical, emotional, and social functioning, while a lower score may indicate more significant impairment or limitations.
Measured: baseline, after 4 weeks of intervention, 12-week follow-up after the end of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start1 Apr 2025 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hong Kong Metropolitan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LIU FANG, Hong Kong Metropolitan University
- Investigators
- Fang LIU, Principal investigator, Hong Kong Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06447272
- Sponsor's protocol ID
- HE-OT2023/13
- Status last verified
- Mar 2025
- First submitted
- 28 May 2024
- Last updated
- 13 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Inspiratory Muscle Training on Respiratory and Diaphragmatic Functions, Balance Control, Exercise Capacity and Quality of Life in People After Stroke: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06447272
- Acronym / sponsor ID
- HE-OT2023/13
- Conditions
- Stroke
- Keywords
- Stroke, Inspiratory muscle training, Diaphragm, Balance control, Exercise capacity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Hong Kong Metropolitan UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 7 Jun 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 randomized controlled trial. This current RCT study will be a continuing project based on the optimal IMT intensity identified from our ongoing study. This ongoing study (registered on ClinicalTrials.gov with the registration number NCT06267768) aims to explore the optimal IMT intensity for the recruitment of diaphragm muscles in people after a stroke. Based on this intensity, the aim of this RCT is to explore the effects of a 4-week protocol of IMT on respiratory function, balance control, exercise capacity, and quality of life in people after a stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham IMT | Sham comparator | Other: sham inspiratory muscle trainingconventional treatment + sham IMT |
| Target IMT | Experimental | Other: target inspiratory muscle trainingconventional treatment + target IMT |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- aged between 40 and 80 years;
- breathing spontaneously;
- clinically diagnosed with ischemic and/or haemorrhagic stroke;
- stroke duration from onset between 1 and 12 months;
- no history of thoracic or abdominal surgery within the last 6 months;
Key exclusion criteria (6 listed)
- acute myocardial infarction or acute heart failure;
- acute pain in any part of the body;
- with respiratory illness or positive clinical signs of impaired respiratory function, such as shortness of breath, hypoxemia, chronic cough, or sputum retention;
- with chronic cardiovascular dysfunction;
- Trunk Impairment Scale (TIS) score ≥ 20;
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 |
|---|---|---|
| sham inspiratory muscle trainingThis group will receive conventional treatment + sham IMT (with 10% MIP as the training intensity) | Other | Sham IMT |
| target inspiratory muscle trainingThis group will receive conventional treatment + target IMT (the IMT identified as optimal intensity based on the results of our undergoing study). | Other | Target IMT |
Primary outcome
Diaphragmatic thickness
Time frame: baseline, after 4 weeks of intervention
The diaphragmatic thickness of both the left and right diaphragms will be measured by ultrasound. (Mindray M9, Shenzhen, China).
9 secondary outcomes
Forced Vital Capacity (FVC)
Time frame: baseline, after 4 weeks of intervention
Forced Expiratory Volume in one second (FEV1)
Time frame: baseline, after 4 weeks of intervention
Maximum Inspiratory Pressure (MIP)
Time frame: baseline, after 4 weeks of intervention
Trunk Impairment Scale (TIS)
Time frame: baseline, after 4 weeks of intervention
Sitting Balance
Time frame: baseline, after 4 weeks of intervention
Timed Up and Go Test (TUG)
Time frame: baseline, after 4 weeks of intervention
Falls efficacy scale international
Time frame: baseline, after 4 weeks of intervention, 12-week follow-up after the end of intervention
6-Minute Walk Test
Time frame: baseline, after 4 weeks of intervention
Stroke Impact Scale
Time frame: baseline, after 4 weeks of intervention, 12-week follow-up after the end of intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Individual participant dataSharing planned: No
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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.
William Wai Nam Tsang contact
Fang LIU principal investigator
Hong Kong Metropolitan University
Questions about this trial
What is this clinical trial studying?
A study testing target inspiratory muscle training in people with Stroke, run by Hong Kong Metropolitan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. 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: opening soon, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fang LIU (+8613603049475, s1350035@live.hkmu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diaphragmatic thickness (time frame: baseline, after 4 weeks of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Mar 2025.