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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
76
This group will receive conventional treatment + sham IMT (with 10% MIP as the training intensity)
This group will receive conventional treatment + target IMT (the IMT identified as optimal intensity based on the results of our undergoing study).
Diaphragmatic thickness
The diaphragmatic thickness of both the left and right diaphragms will be measured by ultrasound. (Mindray M9, Shenzhen, China).
Time frame: baseline, after 4 weeks of intervention
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline, after 4 weeks of intervention, 12-week follow-up after the end of intervention
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