Effects of Respiratory Training on Respiratory and Functional Performance in Patients With Stroke

Study Overview
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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.

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.

Official Title
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Effects of Respiratory Training on Respiratory and Functional Performance in Patients With Stroke

Conditions
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Stroke

Intervention / Treatment
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* Other: respiratory training.
* Other: sham training.


Participation Criteria
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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. 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).

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RT (respiratory training) group<br>Besides traditional rehabilitation therapy, subjects also receive 12-week respiratory training. | Other: respiratory training.<br>* breathing exercise.<br>|
| Sham Comparator: Control group<br>Besides traditional rehabilitation therapy, subjects receive 12-week sham training unrelated to respiratory function. | Other: sham training.<br>* range of motion (ROM) exercise, stretching exercise or positioning exercise.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diaphragm Thickness. | In this study, the mid axillary lines between ribs 8 and 9 on both sides will be checked in a standing posture, then the chest wall is perpendicularly illuminated by a curved array 2-5 MHz transducer (Siemens Sololine G40) in an upright sitting position to observe the region between rib 8 and rib 9 in 2D images. The diaphragm thickness is measured as the distance between two parallel lines that appear bright in the middle of the pleura and in the middle peritoneum. | change from baseline diaphragm thickness at 12, 16, 24, 36 weeks. | 
| Incidence of Pneumonia. | This study will observe the incidence of pneumonia of two groups in the 36-week research course. | change from baseline incidence of pneumonia at 12, 16, 24, 36 weeks. | 
| Brunnstrom's motor recovery stages. | The six sequential stages of motor recovery through which the hemiplegic upper and lower extremities progress used as a method for assessing recovery. | change from baseline Brunnstrom's stages at 12, 16, 24, 36 weeks. | 
| Stroke Rehabilitation Assessment of Movement scale; STREAM. | The STREAM scale is used to evaluate the recovery of voluntary movement and basic mobility following stroke. The scale consists of 30 items or test movements that are equally distributed among 3 subscales: upper-limb movements, lower-limb movements, and basic mobility items. | change from baseline STREAM scores at 12, 16, 24, 36 weeks. | 
| Stroke-Specific Quality of Life scale; SS-QOL. | The SS-QOL scale is a patient-centered outcome measure intended to provide an assessment of health-related quality of life specific to patients with stroke. It consists of twelve commonly affected domains (energy, family roles, language, mobility, mood, personality, self-care, social roles, thinking, upper extremity functioning, vision, and work/productivity) and 49 items. | change from baseline SS-QOL scores at 12, 16, 24, 36 weeks. | 
| Stroke Impact Scale; SIS 3.0. | The SIS 3.0 is a stroke-specific, self-report, health status measure. The scale includes 59 items and assesses 8 domains. It was designed to assess multidimensional stroke outcomes, including strength, hand function, activities of daily living/instrumental activities of daily living (ADL/IADL), mobility, communication, emotion, memory and thinking, and participation. | change from baseline SIS 3.0 scores at 12, 16, 24, 36 weeks. | 
| Twelve-Minute Walk Test. | The distance (in meters) that a subject can walk within twelve minutes is evaluated. | change from baseline Twelve-Minute Walk Test scores at 12, 16, 24, 36 weeks. | 
| Forced Vital Capacity (FVC) in liters. | Resting spirometry of FVC will be performed on a spirometer. | change from baseline FVC at 12, 16, 24, 36 weeks. | 
| Vital Capacity (VC) in liters. | Resting spirometry of VC will be performed on a spirometer. | change from baseline VC at 12, 16, 24, 36 weeks. | 
| Forced Expiratory Volume at 1 second (FEV1) in liters. | Resting spirometry of FEV1 will be performed on a spirometer. | change from baseline FEV1 at 12, 16, 24, 36 weeks. | 
| Ratio of FEV1 to FVC (FEV1/FVC). | Resting spirometry of FEV1/FVC ratio will be performed on a spirometer. | change from baseline FEV1/FVC ratio at 12, 16, 24, 36 weeks. | 
| Forced Expiratory Flow rate 25-75% (FEF 25-75%) in liters per minute. | Resting spirometry of FEF 25-75% will be performed on a spirometer. | change from baseline FEF 25-75% at 12, 16, 24, 36 weeks. | 
| Peak Expiratory Flow Rate (PEFR) in liters per minute. | Resting spirometry of PEFR will be performed on a spirometer. | change from baseline PEFR at 12, 16, 24, 36 weeks. | 
| Maximum Inspiratory Pressure (PImax) in centimeters of water pressure (cmH2O). | Resting spirometry of PImax will be performed on a spirometer. | change from baseline PImax at 12, 16, 24, 36 weeks. | 
| Maximum Expiratory Pressures (PEmax) in centimeters of water pressure (cmH2O). | Resting spirometry of PEmax will be performed on a spirometer. | change from baseline PEmax at 12, 16, 24, 36 weeks. | 
| Maximum Voluntary Ventilation (MVV) in liters per minute. | Resting spirometry of MVV will be performed on a spirometer. | change from baseline MVV at 12, 16, 24, 36 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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respiratory training, functional performance