Effects of Respiratory Muscle Training in Patients With Acute Ischemic Stroke

Stroke, Ischemic Clinical Trial

Official title:

Effects of Respiratory Muscle Training in Patients With Acute Ischemic Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04949334
• Other study ID #: N202009012
• Status: Recruiting
• Phase: N/A
• Start date: September 23, 2021
• Est. completion date: July 15, 2023

Study information

• Verified date: September 2021
• Source: Taipei Medical University Shuang Ho Hospital
• Contact: Ruey Chen, PhD
• Phone: 886-2-2249088
• Email: 18622[@]s.tmu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: July 15, 2023
• Est. primary completion date: January 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Ischemia
• Ischemic Stroke
• Stroke
• Stroke, Ischemic

Intervention

Device:
• Dofin Breathing Strength Builder
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.

Locations

Country	Name	City	State
Taiwan	Shuang Ho Hospital, Taipei Medical University	New Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University Shuang Ho Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory muscle function-1.1	MEP (maximal expiratory pressure)	Baseline
Primary	Respiratory muscle function-1.2	MEP (maximal expiratory pressure)	Within one week after training
Primary	Respiratory muscle function-1.3	MEP (maximal expiratory pressure)	Twelve weeks after training
Primary	Respiratory muscle function-2.1	MIP (maximal inspiratory pressure)	Baseline
Primary	Respiratory muscle function-2.2	MIP (maximal inspiratory pressure)	Within one week after training
Primary	Respiratory muscle function-2.3	MIP (maximal inspiratory pressure)	Twelve weeks after training
Secondary	Dyspnea.1	Dyspnea assessed by Modified Borg Dyspnea Scale (MBS). MBS can go from 0-10, 10 is the more severe condition.	Baseline
Secondary	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
Secondary	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
Secondary	Exercise tolerance.1	Exercise tolerance assessed by six-minute walk test (6MWT).	Baseline
Secondary	Exercise tolerance.2	Exercise tolerance assessed by six-minute walk test (6MWT).	Within one week after training
Secondary	Exercise tolerance.3	Exercise tolerance assessed by six-minute walk test (6MWT).	Twelve weeks after training
Secondary	Body composition.1	Body composition including body fat and muscle mass measured by multi frequency segmental body composition analyzer (TANITA).	Baseline
Secondary	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
Secondary	Body composition.3	Body composition including body fat and muscle mass measured by multi frequency segmental body composition analyzer (TANITA).	Twelve weeks after training
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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