Clinical trial NCT06640101: Effects of Inspiratory Muscle Training on Stroke Rehabilitation Outcomes
Official title: Effect of Inspiratory Muscle Training on Respiratory Function, Diaphragm Thickness, Balance Control, Exercise Capacity and Quality of Life in People After Stroke: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Stroke
Inspiratory muscle training
Diaphragm
Balance control
Exercise capacity
Quality of life
Anticipatory postural adjustment time
Lead sponsor: Hong Kong Metropolitan University
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 84
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Diaphragmatic thickness
timeFrame: baseline, after 4 weeks of intervention
Secondary outcomes:
measure: Maximum Inspiratory Pressure (MIP)
timeFrame: baseline, after 4 weeks of intervention
measure: Forced Vital Capacity (FVC)
timeFrame: baseline, after 4 weeks of intervention
measure: Forced Expiratory Volume in one second (FEV1)
timeFrame: baseline, after 4 weeks of intervention
measure: Sitting Balance
timeFrame: baseline, after 4 weeks of intervention
measure: Trunk Impairment Scale (TIS)
timeFrame: baseline, after 4 weeks of intervention, 12-week follow-up after the end of intervention
measure: Timed Up and Go Test (TUG)
timeFrame: baseline, after 4 weeks of intervention, 12-week follow-up after the end of intervention
measure: Falls efficacy scale international
timeFrame: baseline, after 4 weeks of intervention, 12-week follow-up after the end of intervention
measure: 6-Minute Walk Test
timeFrame: baseline, after 4 weeks of intervention
measure: Stroke Impact Scale
timeFrame: baseline, after 4 weeks of intervention, 12-week follow-up after the end of intervention
measure: Trunk muscle activity
timeFrame: baseline, after 4 weeks of intervention
measure: Anticipatory posture adjustments (APAs) time of trunk muscles
timeFrame: baseline, after 4 weeks of intervention
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen Second People's Hospital
state: None Selected
Study officials:
References: