Stroke
Conditions
Keywords
Stroke, Inspiratory muscle training, Diaphragm, Balance control, Exercise capacity
Brief 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 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.
Interventions
This group will receive conventional treatment + sham IMT (with 10% MIP as the training intensity)
OTHERtarget inspiratory muscle training
This group will receive conventional treatment + target IMT (the IMT identified as optimal intensity based on the results of our undergoing study).
Sponsors
Hong Kong Metropolitan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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; * 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diaphragmatic thickness | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Forced Expiratory Volume in one second (FEV1) | baseline, after 4 weeks of intervention | 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. |
| Maximum Inspiratory Pressure (MIP) | baseline, after 4 weeks of intervention | 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. |
| Trunk Impairment Scale (TIS) | baseline, after 4 weeks of intervention | 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. |
| Sitting Balance | baseline, after 4 weeks of intervention | A force plate will be used to measure changes in the center of pressure during the performance of various tasks in sitting positions. |
| Forced Vital Capacity (FVC) | baseline, after 4 weeks of intervention | 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. |
| Falls efficacy scale international | baseline, after 4 weeks of intervention, 12-week follow-up after the end of intervention | 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. |
| 6-Minute Walk Test | baseline, after 4 weeks of intervention | The 6-Minute Walk Test (6MWT) measures how far someone can walk in six minutes. It assesses exercise capacity and mobility. |
| Stroke Impact Scale | baseline, after 4 weeks of intervention, 12-week follow-up after the end of intervention | 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. |
| Timed Up and Go Test (TUG) | baseline, after 4 weeks of intervention | 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. |
Contacts
Primary ContactFang LIU
Backup ContactWilliam Wai Nam Tsang
Outcome results
None listed