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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham IMT | Sham Comparator | conventional treatment + sham IMT |
|
| Target IMT | Experimental | conventional treatment + target IMT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sham inspiratory muscle training | Other | This group will receive conventional treatment + sham IMT (with 10% MIP as the training intensity) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diaphragmatic thickness | The diaphragmatic thickness of both the left and right diaphragms will be measured by ultrasound. (Mindray M9, Shenzhen, China). | baseline, after 4 weeks of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline, after 4 weeks of intervention |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fang LIU | Contact | +8613603049475 | s1350035@live.hkmu.edu.hk | |
| William Wai Nam Tsang | Contact | wntsang@hkmu.edu.hk |
| Name | Affiliation | Role |
|---|---|---|
| Fang LIU | Hong Kong Metropolitan University | Principal Investigator |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 26, 2025 | Jan 27, 2025 | Prot_SAP_004.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 26, 2025 | Jan 27, 2025 | ICF_005.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| target inspiratory muscle training | Other | This group will receive conventional treatment + target IMT (the IMT identified as optimal intensity based on the results of our undergoing study). |
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | baseline, after 4 weeks of intervention, 12-week follow-up after the end of intervention |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |