Stroke
Conditions
Keywords
Stroke, Inspiratory muscle training, Diaphragm, Balance control, Exercise capacity, Quality of life, Anticipatory postural adjustment time
Brief summary
This study is designed to explore the effects of a 4-week protocol of inspiratory muscle training (IMT) at 50% maximum inspiratory pressure (MIP) on respiratory function, diaphragm thickness, balance control, exercise capacity, and quality of life in people after stroke. To ascertain the effect of IMT on the relationship between diaphragm muscle contraction and activation of other trunk muscles, this study also explores whether any effect of the 4-week IMT protocol on balance control is associated with changes in the anticipatory posture adjustments (APAs) time - the onset time of postural muscles during a required task (e.g., the rapid shoulder flexion test).
Interventions
OTHERsham IMT
with 10% maximum inspiratory pressure (MIP) as the training intensity, IMT will be conducted on a stable surface
OTHERIMT-stable group (sitting on a stable surface)
50% MIP as the training intensity, IMT will be conducted while sitting on a stable surface
OTHERIMT-unstable group (sitting on an unstable surface)
50% MIP as the training intensity, IMT will be conducted while sitting on an unstable surface
OTHERConventional treatment
Participants in all groups will receive a standardised conventional rehabilitation protocol. It includes limb range of motion, muscle tone reduction, strengthening and endurance of limb muscles, transfer skills, task-directed movements, general gait training, and activities of daily living training.
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
* Age ≥ 40 years and \< 80 years; * breathing spontaneously; * clinically diagnosed with ischemic and/or haemorrhagic stroke; * duration of stroke from onset falls within 1 month to 12 months after diagnosis; * no 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; * able to maintain a resting sitting posture without feet support for at least 30 seconds; * no cognitive impairment (Montreal Cognitive Assessment (MoCA) score ≥ 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 and sputum retention); * with chronic cardiovascular dysfunction; * Trunk Impairment Scale (TIS) score ≥ 20. * patient with a nasal feeding tube, tracheal tube and/or any condition that prevents the measurement or the 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 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. |
| 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. |
| 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. |
| Trunk Impairment Scale (TIS) | baseline, after 4 weeks of intervention, 12-week follow-up after the end 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. |
| Timed Up and Go Test (TUG) | baseline, after 4 weeks of intervention, 12-week follow-up after the end 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. |
| 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. |
| 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. A higher overall score suggests better physical, emotional, and social functioning, while a lower score may indicate more significant impairment or limitations. |
| Trunk muscle activity | baseline, after 4 weeks of intervention | Surface electromyography (sEMG) (Noraxon USA, Inc., Scottsdale, AZ, USA) will be used to measure the bilateral muscle activity of the erector spinae, rectus abdominis, external oblique muscle, internal oblique muscle, and transversus abdominis during sitting balance tests on the force plate. |
| Anticipatory posture adjustments (APAs) time of trunk muscles | baseline, after 4 weeks of intervention | Participants will be requested to perform a rapid shoulder flexion test on the force plate. Surface electromyography (sEMG) (Noraxon USA, Inc., Scottsdale, AZ, USA) will be used to measure Anticipatory posture adjustments (APAs) time of trunk muscles. |
| 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 has 16 items, scored from 1 to 4, with higher scores indicating greater fear. It's used in clinical settings to assess fall risk and tailor interventions. |
Countries
China
Contacts
Primary ContactFang LIU
Backup ContactWilliam Wai-nam Tsang
Outcome results
None listed