Effects of Respiratory Muscle Training in Patients With Acute Ischemic Stroke

Not Applicable

• Conditions: Stroke, Ischemic
• Interventions: Device: Dofin Breathing Strength Builder

• Registration Number: NCT04949334
• Lead Sponsor: Taipei Medical University Shuang Ho Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-02-04
• Study First Submitted QC: 2021-06-24
• Study First Posted: 2021-07-02
• Status Verified: 2021-09
• Study Start: 2021-09-23
• Last Update Submitted: 2021-09-23
• Last Update Posted: 2021-09-24
• Primary Completion: 2023-01-15
• Study Completion: 2023-07-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

1. Ischemic stroke diagnosed by MRI
2. Age over 20 years old
3. No worsening of stroke or second stroke this time

Exclusion Criteria

1. Unable to understand instructions normally, or communication difficulties
2. Patients with endotracheal tube or tracheostomy
3. Angina in recent 3 months, myocardial infarction, heart failure
4. Patients with asthma or chronic obstructive pulmonary disease, spontaneous pneumothorax, and ongoing pneumonia
5. Patients with untreated hernias
6. Pregnant
7. Ongoing fever (body temperature>38.5°C)
8. Poor hypertension control (higher than 170/100 mmHg three days before intervention)
9. Patients who have had cerebral hemorrhage or aneurysm

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dofin Breathing Strength Builder	Dofin Breathing Strength Builder	Usual post stroke care and respiratory muscle training

Primary Outcome Measures

Name	Time	Method
Respiratory muscle function-1.3	Twelve weeks after training	MEP (maximal expiratory pressure)
Respiratory muscle function-1.1	Baseline	MEP (maximal expiratory pressure)
Respiratory muscle function-1.2	Within one week after training	MEP (maximal expiratory pressure)
Respiratory muscle function-2.2	Within one week after training	MIP (maximal inspiratory pressure)
Respiratory muscle function-2.1	Baseline	MIP (maximal inspiratory pressure)
Respiratory muscle function-2.3	Twelve weeks after training	MIP (maximal inspiratory pressure)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Shuang Ho Hospital, Taipei Medical University; 🇨🇳 New Taipei City, Taiwan