The Outcome of Respiratory Muscle Training in Stroke Patients: A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- MEP (maximal expiratory pressure)
研究概览
简要总结
Stroke survivors commonly have respiratory muscle weakness, swallowing disturbance, general weakness, reduced the daily living activities and short of motivation for rehabilitation. Respiratory muscle training (RMT) has been reported to improve the pulmonary function, respiratory muscle strength, exercise capacity, sensation of dyspnea and quality of life in several diseases, but rare in stroke patients. Reviewing previous reports, the protocol, intensity and duration of respiratory muscle training is still variable.
Purpose: To investigate the feasibility and efficacy of respiratory muscle training on cardio-pulmonary function, swallowing function, cough function and reduction of incidence of pneumonia in post-stroke patients.
Methods: A prospective, single blinded, randomized study. Consecutive patients with diagnosis of stroke will be proved by magnetic resonance image or computerized tomography. Stroke patients, aged 35-80 years old, with inspiratory muscle weakness or swallowing disturbance will be enrolled and randomly divided into control group (usual rehabilitation alone) and experimental group [inspiratory muscle training (IMT) group for patients with inspiratory muscle weakness and expiratory muscle strengthening training (EMT) for patients with swallowing disturbance]. Each patients will receive usual rehabilitation.
The investigator expect that RMT will be practical for the restoration of respiratory muscle, swallowing function, cough function and voice quality, thereby reduction of the incidence of pneumonia.
详细描述
Stroke patients has been observed to have a higher position of diaphragm in thoracic radiographs on the affected side after 1 day to 2 years of acute event, reduced movement of whole hemi-thorax and excursion of diaphragm on the affected side during deep voluntary breathing, and a tendency for predominance of rib cage contributions during tidal breathing, reduced maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP). Their cardiorespiratory fitness could be markedly impaired within 7 weeks after a stroke. Neves, et al. reported that the recent infarction group had a positive correlation between peak oxygen uptake and both MIP and maximal incremental pressure.
Inspiratory muscle training (IMT). Inspiratory loading can improve limb blood flow, and oxygen uptake efficiency. Threshold inspiratory loading has been recommended to improve inspiratory muscle strength in chronic obstructive pulmonary disease (COPD), bronchiectasis, congestive heart failure (CHF), heart failure, CABG and neuromuscular disease et al. Sutbeyaz et al. ever reported that a statistically significant increase in MIP and MEP of the breathing retraining group in subacute stroke patients. The training intensity of IMT varied from 30% to 60% of MIP, duration of 3 to 7 times per week, the duration of each session from 10-30 minutes for a period of training from 6 to12 weeks.
Expiratory muscle training (EMT): EMT has been shown to improve the dyspnea perception and walking distance within a time unit in COPD persons, aerodynamic changes in cough flow in patients with multiple sclerosis and Parkinson disease, and swallowing safety in PD, and voice aerodynamic. But till now, the protocol, intensity and duration of EMT is still variable, from twice daily at the user's own frequency and tidal volume for 15 min for 4 week, or a week for 1/2 hour, start 15% MEP max, increased by 5-10% each session to 60% of MEP.
Method: Forty-six stroke patients with swallowing disturbance or respiratory muscle weakness, age between 35 to 80 years, will be enrolled. The participants will be randomly assigned by a computer random number generator into two groups, including the experimental group (RMT group plus regular rehabilitation) and the control group (regular rehabilitation alone). All allocations will be concealed in the opaque envelopes. The research assistant will enroll the participants, generate the allocation sequence, and assign participants to their groups after obtaining the informed consent. The research assistant who are responsible for measuring outcomes will be blind to the allocation.
Experimental group will be randomized into 2 groups:
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients identified as stroke and capable of performing voluntary respiratory maneuvers.
排除标准
- •Increased intracranial pressure
- •Uncontrolled hypertension
- •Complicated arrhythmia
- •Decompensated heart failure
- •Unstable angina
- •Myocardial infarction in the preceding 3 months
- •Pneumothorax, bullae/blebs or infection.
结局指标
主要结局
MEP (maximal expiratory pressure)
时间窗: At the beginning and the end of program respectively, up to 6 weeks.
MEP(cm H20) is measured after maximal inspiration while patients sitting and wearing a nose-clip. For MEP, more positive is better.
MIP (maximal inspiratory pressure)
时间窗: At the beginning and the end of program respectively, up to 6 weeks.
MIP(cm H20) is measured after maximal expiration while patients sitting and wearing a nose-clip. For MIP, more negative pressure is better.
次要结局
- Forced expiratory volume 1/Forced vital capacity, FEV1/FVC(%)(At the beginning and the end of program respectively, up to 6 weeks.)
- Resting heart rate(At the beginning and the end of program respectively, up to 6 weeks.)
- Forced vital capacity, FVC(%pred)(liter)(At the beginning and the end of program respectively, up to 6 weeks.)
- Maximal mid-expiratory flow, MMEF(%)(At the beginning and the end of program respectively, up to 6 weeks.)
- Forced vital capacity, FVC(liter)(At the beginning and the end of program respectively, up to 6 weeks.)
- Borg's Scale(At the beginning and the end of program respectively, up to 6 weeks.)
- Peak cough flow(liter/min)(At the beginning and the end of program respectively, up to 6 weeks.)
- Resting respiratory rate(At the beginning and the end of program respectively, up to 6 weeks.)
- Functional Oral Intake Scale(At the beginning and the end of program respectively, up to 6 weeks.)
- Fatigue Assessment Scale(At the beginning and the end of program respectively, up to 6 weeks.)
研究者
Mei-Yun Liaw
Medical doctor in Department of Physical Medicine and Rehabilitation
Chang Gung Memorial Hospital