Effects of Respiratory Training on Respiratory and Functional Performance in Patients With Stroke
NCT ID: NCT02726685
Last Updated: 2018-07-18
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
70 participants
Study Classification
INTERVENTIONAL
Study Start Date
2018-08-01
Study Completion Date
2019-12-31
Brief Summary
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The purpose of the research is to investigate the effects of respiratory training on respiratory and functional performance in patients with stroke.
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Detailed Description
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Stroke ranks third in the global cause of death, behind cancer and coronary heart disease. Stroke is also the third largest cause of death in Taiwan in 2014. Stroke patients in the course of exercise are in addition to muscle weakness and reduced endurance, but usually also accompanied by respiratory damage. From past studies have shown that stroke patients whose respiratory function has significant change, such as decreased respiratory muscle strength, reduced respiratory movement of the affected hemithorax, declined in maximum breathing pressure and decreased amplitude of diaphragmatic movements on the paralyzed side. But whether respiratory training can improve respiratory and functional performance of stroke patients, because of the limited research results could not be confirmed.
Conditions
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Stroke
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
TRIPLE
Participants
Caregivers
Outcome Assessors
Study Groups
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RT (respiratory training) group
Besides traditional rehabilitation therapy, subjects also receive 12-week respiratory training.
Group Type
EXPERIMENTAL
respiratory training.
Intervention Type
OTHER
breathing exercise.
Control group
Besides traditional rehabilitation therapy, subjects receive 12-week sham training unrelated to respiratory function.
Group Type
SHAM_COMPARATOR
sham training.
Intervention Type
OTHER
range of motion (ROM) exercise, stretching exercise or positioning exercise.
Interventions
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respiratory training.
breathing exercise.
Intervention Type
OTHER
sham training.
range of motion (ROM) exercise, stretching exercise or positioning exercise.
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
* first episode of unilateral stroke.
* the definition of stroke was according to the World Health Organization (WHO) criteria (Hatano 1976), confirmed by computerized tomography (CT) or magnetic resonance imaging (MRI).
* older than 20 years.
* had maximum inspiratory pressure (MIP) values lower than 90% of those predicted and adjusted for age and sex.
* facial palsy, which could not prevent proper labial occlusion.
* ability to understand and follow simple verbal instructions.
* no receptive aphasia.
* not undergone thoracic or abdominal surgery.
* the definition of stroke was according to the World Health Organization (WHO) criteria (Hatano 1976), confirmed by computerized tomography (CT) or magnetic resonance imaging (MRI).
* older than 20 years.
* had maximum inspiratory pressure (MIP) values lower than 90% of those predicted and adjusted for age and sex.
* facial palsy, which could not prevent proper labial occlusion.
* ability to understand and follow simple verbal instructions.
* no receptive aphasia.
* not undergone thoracic or abdominal surgery.
Exclusion Criteria
* unable to perform the tests.
* impaired level of consciousness and evidence of gross cognitive impairment.
* excluded patients with comorbidities of respiratory system disease (e.g. chronic obstructive pulmonary disease, asthma, cystic fibrosis), or other diseases leading to the impairment of respiratory muscle (e.g. myasthenia gravis).
* impaired level of consciousness and evidence of gross cognitive impairment.
* excluded patients with comorbidities of respiratory system disease (e.g. chronic obstructive pulmonary disease, asthma, cystic fibrosis), or other diseases leading to the impairment of respiratory muscle (e.g. myasthenia gravis).
Minimum Eligible Age
20 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Chung Shan Medical University
OTHER
Sponsor Role
lead
Responsible Party
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Chung-Hao Chuang
Director of Rehabilitation Therapy Department
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Chung-Hao Chuang, PhD study.
Role: PRINCIPAL_INVESTIGATOR
Chung Shan Medical University
Locations
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Chung Shan Medical University Hospital
Taichung, , Taiwan
Site Status
Countries
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Taiwan
Central Contacts
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Facility Contacts
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References
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Other Identifiers
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CSH-2016-A-006
Identifier Type: -
Identifier Source: org_study_id
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