Clinical trial NCT02726685: Effects of Respiratory Training on Respiratory and Functional Performance in Patients With Stroke
Official title: Effects of Respiratory Training on Respiratory and Functional Performance in Patients With Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: respiratory training
functional performance
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
First posted: 2016-04-04
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the research is to investigate the effects of respiratory training on respiratory and functional performance in patients with stroke.

Detailed description: 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.

Eligibility criteria: 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.

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).

Primary outcomes:
measure: Diaphragm Thickness.
timeFrame: change from baseline diaphragm thickness at 12, 16, 24, 36 weeks.
measure: Incidence of Pneumonia.
timeFrame: change from baseline incidence of pneumonia at 12, 16, 24, 36 weeks.
measure: Brunnstrom's motor recovery stages.
timeFrame: change from baseline Brunnstrom's stages at 12, 16, 24, 36 weeks.
measure: Stroke Rehabilitation Assessment of Movement scale; STREAM.
timeFrame: change from baseline STREAM scores at 12, 16, 24, 36 weeks.
measure: Stroke-Specific Quality of Life scale; SS-QOL.
timeFrame: change from baseline SS-QOL scores at 12, 16, 24, 36 weeks.
measure: Stroke Impact Scale; SIS 3.0.
timeFrame: change from baseline SIS 3.0 scores at 12, 16, 24, 36 weeks.
measure: Twelve-Minute Walk Test.
timeFrame: change from baseline Twelve-Minute Walk Test scores at 12, 16, 24, 36 weeks.
measure: Forced Vital Capacity (FVC) in liters.
timeFrame: change from baseline FVC at 12, 16, 24, 36 weeks.
measure: Vital Capacity (VC) in liters.
timeFrame: change from baseline VC at 12, 16, 24, 36 weeks.
measure: Forced Expiratory Volume at 1 second (FEV1) in liters.
timeFrame: change from baseline FEV1 at 12, 16, 24, 36 weeks.
measure: Ratio of FEV1 to FVC (FEV1/FVC).
timeFrame: change from baseline FEV1/FVC ratio at 12, 16, 24, 36 weeks.
measure: Forced Expiratory Flow rate 25-75% (FEF 25-75%) in liters per minute.
timeFrame: change from baseline FEF 25-75% at 12, 16, 24, 36 weeks.
measure: Peak Expiratory Flow Rate (PEFR) in liters per minute.
timeFrame: change from baseline PEFR at 12, 16, 24, 36 weeks.
measure: Maximum Inspiratory Pressure (PImax) in centimeters of water pressure (cmH2O).
timeFrame: change from baseline PImax at 12, 16, 24, 36 weeks.
measure: Maximum Expiratory Pressures (PEmax) in centimeters of water pressure (cmH2O).
timeFrame: change from baseline PEmax at 12, 16, 24, 36 weeks.
measure: Maximum Voluntary Ventilation (MVV) in liters per minute.
timeFrame: change from baseline MVV at 12, 16, 24, 36 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
Study officials:
affiliation: Chung Shan Medical University
name: Chung-Hao Chuang, PhD study.
role: PRINCIPAL_INVESTIGATOR
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