About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Parallel
Treatments tested in this trial
sham inspiratory muscle training
Other interventionThis group will receive conventional treatment + sham IMT (with 10% MIP as the training intensity)
target inspiratory muscle training
Other interventionThis group will receive conventional treatment + target IMT (the IMT identified as optimal intensity based on the results of our undergoing study).
Treatment groups
Trial outcomes
Primary outcomes
Diaphragmatic thickness
The diaphragmatic thickness of both the left and right diaphragms will be measured by ultrasound. (Mindray M9, Shenzhen, China).
Secondary outcomes
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.
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.
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.
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.
Locations
Sponsors and contacts
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