Effects of Respiratory Muscle Training in Patients With Acute Ischemic Stroke

Study Overview
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Brief Summary
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After acute ischemic stroke, the muscle strength of the limbs of the patients will decrease. Moreover, the respiratory muscles may also be affected. The respiratory muscle training may improve the respiratory recovery and prevent pulmonary complication.

Detailed Description
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After acute ischemic stroke, the muscle strength of the limbs of the patients will decrease. Moreover, the respiratory muscles may also be affected. The worsening of the respiratory function is weakened and lung function declines, leading to dysfunction of expectoration and swallowing, and increasing the incidence of pneumonia after stroke. In addition, it will also lead to a decline in activity ability, which in turn affects the quality of life. The respiratory muscle training may improve the respiratory recovery and prevent pulmonary complication.

Official Title
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Effects of Respiratory Muscle Training in Patients With Acute Ischemic Stroke

Conditions
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Stroke, Ischemic

Intervention / Treatment
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* Device: Dofin Breathing Strength Builder


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ischemic stroke diagnosed by MRI Age over 20 years old No worsening of stroke or second stroke this time Exclusion Criteria: Unable to understand instructions normally, or communication difficulties Patients with endotracheal tube or tracheostomy Angina in recent 3 months, myocardial infarction, heart failure Patients with asthma or chronic obstructive pulmonary disease, spontaneous pneumothorax, and ongoing pneumonia Patients with untreated hernias Pregnant Ongoing fever (body temperature>38.5°C) Poor hypertension control (higher than 170/100 mmHg three days before intervention) Patients who have had cerebral hemorrhage or aneurysm

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dofin Breathing Strength Builder<br>Usual post stroke care and respiratory muscle training | Device: Dofin Breathing Strength Builder<br>* If the patient's condition is stable, respiratory muscle training will be performed under Dofin Breathing Strength Builder 7 days after stroke. The patient will receive respiratory muscle training by repetition of 30 times, two courses per day, x 7 days, for three weeks. The initial load was set at 30% of the participants' maximal baseline strength and increased weekly at intervals of 2 cmH2O.<br>|
| No Intervention: Usual post stroke care<br>Usual post stroke care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory muscle function-1.1 | MEP (maximal expiratory pressure) | Baseline | 
| Respiratory muscle function-1.2 | MEP (maximal expiratory pressure) | Within one week after training | 
| Respiratory muscle function-1.3 | MEP (maximal expiratory pressure) | Twelve weeks after training | 
| Respiratory muscle function-2.1 | MIP (maximal inspiratory pressure) | Baseline | 
| Respiratory muscle function-2.2 | MIP (maximal inspiratory pressure) | Within one week after training | 
| Respiratory muscle function-2.3 | MIP (maximal inspiratory pressure) | Twelve weeks after training | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dyspnea.1 | Dyspnea assessed by Modified Borg Dyspnea Scale (MBS). MBS can go from 0-10, 10 is the more severe condition. | Baseline | 
| Dyspnea.2 | Dyspnea assessed by Modified Borg Dyspnea Scale (MBS). MBS can go from 0-10, 10 is the more severe condition. | Within one week after training | 
| Dyspnea.3 | Dyspnea assessed by Modified Borg Dyspnea Scale (MBS). MBS can go from 0-10, 10 is the more severe condition. | Twelve weeks after training | 
| Exercise tolerance.1 | Exercise tolerance assessed by six-minute walk test (6MWT). | Baseline | 
| Exercise tolerance.2 | Exercise tolerance assessed by six-minute walk test (6MWT). | Within one week after training | 
| Exercise tolerance.3 | Exercise tolerance assessed by six-minute walk test (6MWT). | Twelve weeks after training | 
| Body composition.1 | Body composition including body fat and muscle mass measured by multi frequency segmental body composition analyzer (TANITA). | Baseline | 
| Body composition.2 | Body composition including body fat and muscle mass measured by multi frequency segmental body composition analyzer (TANITA). | Within one week after training | 
| Body composition.3 | Body composition including body fat and muscle mass measured by multi frequency segmental body composition analyzer (TANITA). | Twelve weeks after training | 
| Life quality.1 | Quality of life assessed by Short-form 12 (SF-12). SF-12 can go from 0-100, 100 is the better life quality. | Baseline | 
| Life quality.2 | Quality of life assessed by Short-form 12 (SF-12). SF-12 can go from 0-100, 100 is the better life quality. | Within one week after training | 
| Life quality.3 | Quality of life assessed by Short-form 12 (SF-12). SF-12 can go from 0-100, 100 is the better life quality. | Twelve weeks after training | 
| Swallowing.1 | Swallowing function assessed by the Functional Oral Intake Scale (FOIS). The score can go from 1-7, 7 is the better oral intake condition. | Baseline | 
| Swallowing.2 | Swallowing function assessed by the Functional Oral Intake Scale (FOIS). The score can go from 1-7, 7 is the better oral intake condition. | Within one week after training | 
| Swallowing.3 | Swallowing function assessed by the Functional Oral Intake Scale (FOIS). The score can go from 1-7, 7 is the better oral intake condition. | Twelve weeks after training | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Respiratory muscle training, Respiratory function