Effects of Respiratory Training on Respiratory and Functional Performance in Patients With Stroke
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Maximum Inspiratory Pressure (PImax) in centimeters of water pressure (cmH2O).
研究概览
简要总结
The purpose of the research is to investigate the effects of respiratory training on respiratory and functional performance in patients with stroke.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
RT (respiratory training) group
Besides traditional rehabilitation therapy, subjects also receive 12-week respiratory training.
干预措施: respiratory training. (Other)
Control group
Besides traditional rehabilitation therapy, subjects receive 12-week sham training unrelated to respiratory function.
干预措施: sham training. (Other)
结局指标
主要结局
Maximum Inspiratory Pressure (PImax) in centimeters of water pressure (cmH2O).
时间窗: change from baseline PImax at 12, 16, 24, 36 weeks.
Resting spirometry of PImax will be performed on a spirometer.
Incidence of Pneumonia.
时间窗: change from baseline incidence of pneumonia at 12, 16, 24, 36 weeks.
This study will observe the incidence of pneumonia of two groups in the 36-week research course.
Stroke Rehabilitation Assessment of Movement scale; STREAM.
时间窗: change from baseline STREAM scores at 12, 16, 24, 36 weeks.
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.
Ratio of FEV1 to FVC (FEV1/FVC).
时间窗: change from baseline FEV1/FVC ratio at 12, 16, 24, 36 weeks.
Resting spirometry of FEV1/FVC ratio will be performed on a spirometer.
Forced Expiratory Flow rate 25-75% (FEF 25-75%) in liters per minute.
时间窗: change from baseline FEF 25-75% at 12, 16, 24, 36 weeks.
Resting spirometry of FEF 25-75% will be performed on a spirometer.
Diaphragm Thickness.
时间窗: change from baseline diaphragm thickness at 12, 16, 24, 36 weeks.
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.
Brunnstrom's motor recovery stages.
时间窗: change from baseline Brunnstrom's stages at 12, 16, 24, 36 weeks.
The six sequential stages of motor recovery through which the hemiplegic upper and lower extremities progress used as a method for assessing recovery.
Stroke-Specific Quality of Life scale; SS-QOL.
时间窗: change from baseline SS-QOL scores at 12, 16, 24, 36 weeks.
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.
Twelve-Minute Walk Test.
时间窗: change from baseline Twelve-Minute Walk Test scores at 12, 16, 24, 36 weeks.
The distance (in meters) that a subject can walk within twelve minutes is evaluated.
Forced Vital Capacity (FVC) in liters.
时间窗: change from baseline FVC at 12, 16, 24, 36 weeks.
Resting spirometry of FVC will be performed on a spirometer.
Vital Capacity (VC) in liters.
时间窗: change from baseline VC at 12, 16, 24, 36 weeks.
Resting spirometry of VC will be performed on a spirometer.
Peak Expiratory Flow Rate (PEFR) in liters per minute.
时间窗: change from baseline PEFR at 12, 16, 24, 36 weeks.
Resting spirometry of PEFR will be performed on a spirometer.
Forced Expiratory Volume at 1 second (FEV1) in liters.
时间窗: change from baseline FEV1 at 12, 16, 24, 36 weeks.
Resting spirometry of FEV1 will be performed on a spirometer.
Stroke Impact Scale; SIS 3.0.
时间窗: change from baseline SIS 3.0 scores at 12, 16, 24, 36 weeks.
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.
Maximum Expiratory Pressures (PEmax) in centimeters of water pressure (cmH2O).
时间窗: change from baseline PEmax at 12, 16, 24, 36 weeks.
Resting spirometry of PEmax will be performed on a spirometer.
Maximum Voluntary Ventilation (MVV) in liters per minute.
时间窗: change from baseline MVV at 12, 16, 24, 36 weeks.
Resting spirometry of MVV will be performed on a spirometer.
次要结局
未报告次要终点
研究者
Chung-Hao Chuang
Director of Rehabilitation Therapy Department
Chung Shan Medical University