Effects of Respiratory Muscle Training in Patients With Acute Ischemic Stroke

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke, Ischemic
• Intervention / Treatment: Device: Dofin Breathing Strength Builder

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 Type: Interventional
• Enrollment (Anticipated): 144
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ruey Chen, PhD; Phone Number: 8620 886-2-2249088; Email: 18622@s.tmu.edu.tw
• Study Contact Backup: Name: Tzu-Ang Chen, MD; Phone Number: 886-915855505; Email: b101103035@tmu.edu.tw

Study Locations

• Taiwan
  • New Taipei City, Taiwan, 235
    • Recruiting
    • Shuang Ho Hospital, Taipei Medical University
    • Contact: Ruey Chen, PhD; Phone Number: 8620 886-2-2249088; Email: 18622@s.tmu.edu.tw
    • Contact: Tzu-Ang Chen, MD; Phone Number: 886-915855505; Email: b101103035@tmu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dofin Breathing Strength Builder; Usual post stroke care and respiratory muscle training	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.
No Intervention: Usual post stroke care

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Taipei Medical University Shuang Ho Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2021
• Primary Completion (Anticipated): January 15, 2023
• Study Completion (Anticipated): July 15, 2023

Study Registration Dates

• First Submitted: February 4, 2021
• First Submitted That Met QC Criteria: June 24, 2021
• First Posted (Actual): July 2, 2021

Study Record Updates

• Last Update Posted (Actual): September 24, 2021
• Last Update Submitted That Met QC Criteria: September 23, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Stroke; Respiratory function; Respiratory muscle training
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Ischemia
• Other Study ID Numbers: N202009012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No