Effects of Inspiratory Muscle Training on Respiratory and Diaphragmatic Functions, 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
- 尚未招募
- 入组人数
- 76
- 主要终点
- Diaphragmatic thickness
研究概览
简要总结
This is a randomized controlled trial. This current RCT study will be a continuing project based on the optimal IMT intensity identified from our ongoing study. This ongoing study (registered on ClinicalTrials.gov with the registration number NCT06267768) aims to explore the optimal IMT intensity for the recruitment of diaphragm muscles in people after a stroke. Based on this intensity, the aim of this RCT is to explore the effects of a 4-week protocol of IMT on respiratory function, balance control, exercise capacity, and quality of life in people after a stroke.
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
- •aged between 40 and 80 years;
- •breathing spontaneously;
- •clinically diagnosed with ischemic and/or haemorrhagic stroke;
- •stroke duration from onset between 1 and 12 months;
- •no history of 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;
- •capable of maintaining a resting sitting posture without feet support for at least 30 seconds;
- •no cognitive impairment, as indicated by a Montreal Cognitive Assessment (MoCA) score of ≥ 26;
- •able to independently walk at least 10 meters with or without an assistive device.
- •Exclusion criteria:
- •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, or sputum retention;
- •with chronic cardiovascular dysfunction;
- •Trunk Impairment Scale (TIS) score ≥ 20;
- •presence of a nasal feeding tube, tracheal tube, or any condition that prevents the measurement or implementation of the study procedure.
排除标准
- 未提供
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
- Forced Vital Capacity (FVC)(baseline, after 4 weeks of intervention)
- Forced Expiratory Volume in one second (FEV1)(baseline, after 4 weeks of intervention)
- Maximum Inspiratory Pressure (MIP)(baseline, after 4 weeks of intervention)
- Trunk Impairment Scale (TIS)(baseline, after 4 weeks of intervention)
- Sitting Balance(baseline, after 4 weeks of intervention)
- Timed Up and Go Test (TUG)(baseline, after 4 weeks 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)
研究者
LIU FANG
Principal Investigator
Hong Kong Metropolitan University