Effects of Respiratory Muscle Training in Patients With Acute Ischemic Stroke

NCT ID: NCT04949334

Last Updated: 2021-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-23

Study Completion Date

2023-07-15

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.

Conditions

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Stroke, Ischemic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Dofin Breathing Strength Builder

Usual post stroke care and respiratory muscle training

Group Type EXPERIMENTAL

Dofin Breathing Strength Builder

Intervention Type DEVICE

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.

Usual post stroke care

Usual post stroke care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Medical University Shuang Ho Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chen ruey

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shuang Ho Hospital, Taipei Medical University

New Taipei City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Ruey Chen, PhD

Role: CONTACT

886-2-2249088 ext. 8620

Tzu-Ang Chen, MD

Role: CONTACT

886-915855505

Facility Contacts

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Ruey Chen, PhD

Role: primary

886-2-2249088 ext. 8620

Tzu-Ang Chen, MD

Role: backup

886-915855505

Other Identifiers

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N202009012

Identifier Type: -

Identifier Source: org_study_id

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