Effect of Inspiratory Muscle Training on Respiratory Function, Diaphragm Thickness, Balance Control, Exercise Capacity and Quality of Life in People After Stroke: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Diaphragmatic thickness
研究概览
简要总结
This study is designed to explore the effects of a 4-week protocol of inspiratory muscle training (IMT) at 50% maximum inspiratory pressure (MIP) on respiratory function, diaphragm thickness, balance control, exercise capacity, and quality of life in people after stroke. To ascertain the effect of IMT on the relationship between diaphragm muscle contraction and activation of other trunk muscles, this study also explores whether any effect of the 4-week IMT protocol on balance control is associated with changes in the anticipatory posture adjustments (APAs) time - the onset time of postural muscles during a required task (e.g., the rapid shoulder flexion test).
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 40 years and < 80 years;
- •breathing spontaneously;
- •clinically diagnosed with ischemic and/or haemorrhagic stroke;
- •duration of stroke from onset falls within 1 month to 12 months after diagnosis;
- •no thoracic or abdominal surgery within the last 6 months;
- •able to understand and follow verbal instructions;
- •no facial palsy, or mild facial palsy without limitation of labial occlusion;
- •able to maintain a resting sitting posture without feet support for at least 30 seconds;
- •no cognitive impairment (Montreal Cognitive Assessment (MoCA) score ≥ 26);
- •able to independently walk at least 10 meters with or without an assistive device.
排除标准
- •acute myocardial infarction or acute heart failure;
- •acute pain in any part of the body;
- •with respiratory illness or positive clinical signs of impaired respiratory function (such as shortness of breath, hypoxemia, chronic cough and sputum retention);
- •with chronic cardiovascular dysfunction;
- •Trunk Impairment Scale (TIS) score ≥
- •patient with a nasal feeding tube, tracheal tube and/or any condition that prevents the measurement or the implementation of the study procedure.
结局指标
主要结局
Diaphragmatic thickness
时间窗: baseline, after 4 weeks of intervention
The diaphragmatic thickness of both the left and right diaphragms will be measured by ultrasound. (Mindray M9, Shenzhen, China).
次要结局
- Maximum Inspiratory Pressure (MIP)(baseline, after 4 weeks of intervention)
- Forced Vital Capacity (FVC)(baseline, after 4 weeks of intervention)
- Forced Expiratory Volume in one second (FEV1)(baseline, after 4 weeks of intervention)
- Sitting Balance(baseline, after 4 weeks of intervention)
- Trunk Impairment Scale (TIS)(baseline, after 4 weeks of intervention, 12-week follow-up after the end of intervention)
- Timed Up and Go Test (TUG)(baseline, after 4 weeks of intervention, 12-week follow-up after the end of intervention)
- Falls efficacy scale international(baseline, after 4 weeks of intervention, 12-week follow-up after the end of intervention)
- 6-Minute Walk Test(baseline, after 4 weeks of intervention)
- Stroke Impact Scale(baseline, after 4 weeks of intervention, 12-week follow-up after the end of intervention)
- Trunk muscle activity(baseline, after 4 weeks of intervention)
- Anticipatory posture adjustments (APAs) time of trunk muscles(baseline, after 4 weeks of intervention)
研究者
LIU FANG
Principal Investigator
Hong Kong Metropolitan University