The Efficacy of Bedside Respiratory Muscle Training in Stroke Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- functional vital capacity
研究概览
简要总结
Objectives: To investigate the efficacy of bedside respiratory muscle training on pulmonary function and stroke-related disabilities in stroke patients.
Design: Prospective randomized controlled trial
Setting: A single physical medicine and rehabilitation department at a university hospital
Participants: Stroke patients in a rehabilitation unit were recruited and randomly assigned to either the intervention group or the control group.
Intervention: Both groups participated in a conventional stroke rehabilitation program. During the study period, the intervention group received bedside respiratory muscle training twice a day for three weeks. The respiratory muscle training consisted of (1) a breath stacking exercise, (2) inspiratory muscle training and (3) expiratory muscle training. The participants were evaluated at baseline and again at the end of the study (3 weeks later).
Main Outcome Measures: The primary outcomes were measures of pulmonary function: functional vital capacity (FVC), forced expiratory volume in one second (FEV1) and peak flow.
Secondary outcomes were stroke-related disabilities assessed by the following: National Institutes of Health Stroke Scale, Modified Barthel Index, Berg Balance Scale, Fugl-Meyer Assessment, the Korean Mini-Mental State Examination, and the incidence of pneumonia.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •older than 18 years of age,
- •first episode of stroke within three months,
- •moderate to severe stroke impairment, defined as a NIHSS score from 5-36, and
- •the ability to follow instructions and engage in the study program.
排除标准
- •a medical history of persistent cardiopulmonary disease,
- •other coexisting brain disorders, such as brain tumor,
- •poorly controlled hypertension, which was defined as a blood pressure higher than 180/100 mmHg during the preceding 24 hours,
- •severe facial palsy or other oropharyngeal structural abnormality,
- •severe oral apraxia, and (6) having a tracheostomy.
结局指标
主要结局
functional vital capacity
时间窗: 21 days
functional vital capacity in percent (%)
Forced expiratory volume
时间窗: 21 days
Forced expiratory volume in one second in percent (%)
Peak flow
时间窗: 21 days
Peak flow in milliliter
次要结局
未报告次要终点
研究者
Hyun-Joon Yoo
Principal Investigator
Korea University Anam Hospital