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Effects of Respiratory Muscle Training in Patients With Acute Ischemic Stroke

Primary Purpose

Stroke, Ischemic

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Dofin Breathing Strength Builder
Sponsored by
Taipei Medical University Shuang Ho Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Ischemic focused on measuring Stroke, Respiratory muscle training, Respiratory function

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shuang Ho Hospital, Taipei Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Dofin Breathing Strength Builder

Usual post stroke care

Arm Description

Usual post stroke care and respiratory muscle training

Usual post stroke care

Outcomes

Primary Outcome Measures

Respiratory muscle function-1.1
MEP (maximal expiratory pressure)
Respiratory muscle function-1.2
MEP (maximal expiratory pressure)
Respiratory muscle function-1.3
MEP (maximal expiratory pressure)
Respiratory muscle function-2.1
MIP (maximal inspiratory pressure)
Respiratory muscle function-2.2
MIP (maximal inspiratory pressure)
Respiratory muscle function-2.3
MIP (maximal inspiratory pressure)

Secondary Outcome Measures

Dyspnea.1
Dyspnea assessed by Modified Borg Dyspnea Scale (MBS). MBS can go from 0-10, 10 is the more severe condition.
Dyspnea.2
Dyspnea assessed by Modified Borg Dyspnea Scale (MBS). MBS can go from 0-10, 10 is the more severe condition.
Dyspnea.3
Dyspnea assessed by Modified Borg Dyspnea Scale (MBS). MBS can go from 0-10, 10 is the more severe condition.
Exercise tolerance.1
Exercise tolerance assessed by six-minute walk test (6MWT).
Exercise tolerance.2
Exercise tolerance assessed by six-minute walk test (6MWT).
Exercise tolerance.3
Exercise tolerance assessed by six-minute walk test (6MWT).
Body composition.1
Body composition including body fat and muscle mass measured by multi frequency segmental body composition analyzer (TANITA).
Body composition.2
Body composition including body fat and muscle mass measured by multi frequency segmental body composition analyzer (TANITA).
Body composition.3
Body composition including body fat and muscle mass measured by multi frequency segmental body composition analyzer (TANITA).
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.
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.
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.
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.
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.
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.

Full Information

First Posted
February 4, 2021
Last Updated
September 23, 2021
Sponsor
Taipei Medical University Shuang Ho Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04949334
Brief Title
Effects of Respiratory Muscle Training in Patients With Acute Ischemic Stroke
Official Title
Effects of Respiratory Muscle Training in Patients With Acute Ischemic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 23, 2021 (Actual)
Primary Completion Date
January 15, 2023 (Anticipated)
Study Completion Date
July 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University Shuang Ho Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic
Keywords
Stroke, Respiratory muscle training, Respiratory function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
144 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dofin Breathing Strength Builder
Arm Type
Experimental
Arm Description
Usual post stroke care and respiratory muscle training
Arm Title
Usual post stroke care
Arm Type
No Intervention
Arm Description
Usual post stroke care
Intervention Type
Device
Intervention Name(s)
Dofin Breathing Strength Builder
Intervention Description
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.
Primary Outcome Measure Information:
Title
Respiratory muscle function-1.1
Description
MEP (maximal expiratory pressure)
Time Frame
Baseline
Title
Respiratory muscle function-1.2
Description
MEP (maximal expiratory pressure)
Time Frame
Within one week after training
Title
Respiratory muscle function-1.3
Description
MEP (maximal expiratory pressure)
Time Frame
Twelve weeks after training
Title
Respiratory muscle function-2.1
Description
MIP (maximal inspiratory pressure)
Time Frame
Baseline
Title
Respiratory muscle function-2.2
Description
MIP (maximal inspiratory pressure)
Time Frame
Within one week after training
Title
Respiratory muscle function-2.3
Description
MIP (maximal inspiratory pressure)
Time Frame
Twelve weeks after training
Secondary Outcome Measure Information:
Title
Dyspnea.1
Description
Dyspnea assessed by Modified Borg Dyspnea Scale (MBS). MBS can go from 0-10, 10 is the more severe condition.
Time Frame
Baseline
Title
Dyspnea.2
Description
Dyspnea assessed by Modified Borg Dyspnea Scale (MBS). MBS can go from 0-10, 10 is the more severe condition.
Time Frame
Within one week after training
Title
Dyspnea.3
Description
Dyspnea assessed by Modified Borg Dyspnea Scale (MBS). MBS can go from 0-10, 10 is the more severe condition.
Time Frame
Twelve weeks after training
Title
Exercise tolerance.1
Description
Exercise tolerance assessed by six-minute walk test (6MWT).
Time Frame
Baseline
Title
Exercise tolerance.2
Description
Exercise tolerance assessed by six-minute walk test (6MWT).
Time Frame
Within one week after training
Title
Exercise tolerance.3
Description
Exercise tolerance assessed by six-minute walk test (6MWT).
Time Frame
Twelve weeks after training
Title
Body composition.1
Description
Body composition including body fat and muscle mass measured by multi frequency segmental body composition analyzer (TANITA).
Time Frame
Baseline
Title
Body composition.2
Description
Body composition including body fat and muscle mass measured by multi frequency segmental body composition analyzer (TANITA).
Time Frame
Within one week after training
Title
Body composition.3
Description
Body composition including body fat and muscle mass measured by multi frequency segmental body composition analyzer (TANITA).
Time Frame
Twelve weeks after training
Title
Life quality.1
Description
Quality of life assessed by Short-form 12 (SF-12). SF-12 can go from 0-100, 100 is the better life quality.
Time Frame
Baseline
Title
Life quality.2
Description
Quality of life assessed by Short-form 12 (SF-12). SF-12 can go from 0-100, 100 is the better life quality.
Time Frame
Within one week after training
Title
Life quality.3
Description
Quality of life assessed by Short-form 12 (SF-12). SF-12 can go from 0-100, 100 is the better life quality.
Time Frame
Twelve weeks after training
Title
Swallowing.1
Description
Swallowing function assessed by the Functional Oral Intake Scale (FOIS). The score can go from 1-7, 7 is the better oral intake condition.
Time Frame
Baseline
Title
Swallowing.2
Description
Swallowing function assessed by the Functional Oral Intake Scale (FOIS). The score can go from 1-7, 7 is the better oral intake condition.
Time Frame
Within one week after training
Title
Swallowing.3
Description
Swallowing function assessed by the Functional Oral Intake Scale (FOIS). The score can go from 1-7, 7 is the better oral intake condition.
Time Frame
Twelve weeks after training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ruey Chen, PhD
Phone
886-2-2249088
Ext
8620
Email
18622@s.tmu.edu.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Tzu-Ang Chen, MD
Phone
886-915855505
Email
b101103035@tmu.edu.tw
Facility Information:
Facility Name
Shuang Ho Hospital, Taipei Medical University
City
New Taipei City
ZIP/Postal Code
235
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruey Chen, PhD
Phone
886-2-2249088
Ext
8620
Email
18622@s.tmu.edu.tw
First Name & Middle Initial & Last Name & Degree
Tzu-Ang Chen, MD
Phone
886-915855505
Email
b101103035@tmu.edu.tw

12. IPD Sharing Statement

Plan to Share IPD
Yes

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Effects of Respiratory Muscle Training in Patients With Acute Ischemic Stroke

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