The Optimal Treatment Duration for Inspiratory Muscle Strengthening Exercises in Stroke Patients: A Double-blind Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- The change in maximal inspiratory pressure
研究概览
简要总结
The first aim of this study is if there is any difference between 4 or 8 weeks of inspiratory muscle training ( IMT ) exercises groups and control groups in stroke survivors. The secondary aims of this study is if there is any difference in walking capacity (in 8th, 12th, 24th weeks) and pulmonary complications (pneumonia incidences) in long term follow-ups (6 months) in these aforementioned groups
详细描述
Stroke is one of the leading causes of death and disability. It is not only because of loss of extremity motions but also loss of inspiratory muscle strength. In this study we aimed to determine the optimum duration for inspiratory muscle training exercises for stroke survivors since there is not enough data about it in the literature.
The study will include at least 54 patients in total and 18 in each groups ( two intervention and one control) . The patients will be evaluated for angina, chronic obstructive pulmonary disease, congestive heart disease; in these conditions the patients will be excluded from the study. Also in first examinations we will evaluate the maximal inspiratory pressure (MIP) of patients, of them the ones with MIP measurements above 80 mmH2O will also be excluded since it is the expected value in normal people.
After admission and randomizing the patients, baseline measurements of MIP, 6-minutes walking test will be done. In intervention groups the patients will get 30 minutes of inspiratory muscle training exercises ( 15 minutes of two session each day) with threshold IMT device every weekday. And in control group, the patients will get sham intervention for 8 weeks. The MIP and 6-minutes walking test will be done in 8th,12th and 24th weeks. And also in 24th week we will record the pneumonia incidence if occured.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
the assessor who will investigate the results and the investigator who will perform the MIP and 6-minutes walking test will be blinded to the randomization
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ischemic/ hemorrhagic stroke
- •Stroke duration> 3 months
- •Age> 18 years old
- •Baseline maximal inspiratory pressure below 80 cmH2O
排除标准
- •Cognitive deficiency
- •Facial paralysis
- •Chronic obstructive pulmonary disease
- •Congestive heart disease
- •Myocardial infarction in last three months
- •Angina pectoris
研究组 & 干预措施
intervention 1
in this group patients will get 4 week of inspiratory muscle training exercise 30 minutes every weekday ( 15 minutes of two session in each day)
干预措施: inspiratory muscle training (Other)
intervention 2
in this group patients will get 8 week of inspiratory muscle training exercise 30 minutes every weekday ( 15 minutes of two session in each day)
干预措施: inspiratory muscle training (Other)
control group
this group will get sham intervention with 0 to 5 cmH2O resistance
干预措施: sham intervention (Other)
结局指标
主要结局
The change in maximal inspiratory pressure
时间窗: Baseline and week 8,12, 24
Measured with MicroRPM (respiratory pressure meter) pressurometer device orally
次要结局
- Pneumonia incidence(Week 24)
- The change in walking capacity(Baseline and week 8,12, 24)