"More Air - Better Performance - Faster Recovery": Study Protocol for a Randomised Controlled Trial of the Effect of Inspiratory Muscle Training for Adults Post-stroke
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Maximal inspiratory pressure (MIP)
研究概览
简要总结
The objective of this study is to investigate i) the effect of 3 weeks IMT to adults post-stroke to maximal inspiratory pressure (MIP) and ii) the effects of 3 weeks IMT to the degree of dependency in activities of daily living, endurance in gait, fatigue, voice volume, phonation endurance, and expiratory function.
Methods/Design: Randomised controlled trial (RCT) comparing IMT to conventional neurorehabilitation (usual practise). 80 patients, with reduced maximal inspiration pressure (MIP) hospitalized at a specialized neurorehabilitation hospital in Denmark will be included.
详细描述
Background: Stroke results in varying disabilities physical, cognitive, emotional and/or social both in short term and long term. Motor impairments are significantly persistent consequences post-stroke among these are decreased respiratory muscle function, decreased ability to expand thorax and postural dysfunction. These deficits influence the patient's ability in daily activities, fatigue, endurance and quality of life. Inspiratory muscle training (IMT) is training to improve the strength and endurance of diaphragm and the external intercostal muscles. The objective of this study is to investigate i) the effect of 3 weeks IMT to adults post-stroke to maximal inspiratory pressure (MIP) and ii) the effects of 3 weeks IMT to the degree of dependency in activities of daily living, endurance in gait, fatigue, voice volume, phonation endurance, and expiratory function.
Methods/Design: Randomised controlled trial (RCT) comparing IMT to conventional neurorehabilitation (usual practise). 80 patients, with reduced maximal inspiration pressure (MIP) hospitalized at a specialized neurorehabilitation hospital in Denmark will be included. The intervention group will add-on IMT sessions exercising at 30 % of MIP. Patients in the intervention group perform 2 sessions a day (One session of IMT with IMT threshold flute consists of 2 times 15 inspirations in normal breathing rhythm (5-10 min)), 7 days a week for 3 weeks. Training can be with or without supervision of physiotherapist.
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)
盲法说明
External assessor unknown to the participants of the intervention group and control group
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
- •First time brain infarction or brain haemorrhage 0-6 month.
- •Able to give written consent and being cognitive and communicative able to understand and participate in the maximal inspiration pressure test (MIP)
- •Reduced MIP below gender and age specific normal standard
排除标准
- •Diagnosis of myocardial infarction within the last 3 months
- •Significant pulmonary disease (severe COPD), saturation below 90 if having COPD for others saturation below 92
- •Neurological deficits other than stroke
- •Facial palsy that affects proper labial occlusion
- •Dizziness or nausea/vomiting during MIP-testing.
结局指标
主要结局
Maximal inspiratory pressure (MIP)
时间窗: Assessed 0-4 days before intervention, 0-4 days after ended intervention assessment and 3 months after ended intervention
Change of MIP assess with the Power Breath. This is an objective measurement to describe the inspiratory capacity. Age specific
次要结局
- Voice volume(Assessed 0-4 days before intervention, 0-4 days after ended intervention assessment and 3 months after ended intervention)
- Functional Independence Measure (FIM) - both total score ( range from 18 to 126, with higher scores indicating more independence) and motor sub score (max 91)(Assessed 0-4 days before intervention, 0-4 days after ended intervention assessment and 3 months after ended intervention)
- Fatigue Severity Scale (FSS)(Assessed 0-4 days before intervention, 0-4 days after ended intervention assessment and 3 months after ended intervention)
- Expiratory function(Assessed 0-4 days before intervention, 0-4 days after ended intervention assessment and 3 months after ended intervention)
- 6-minutes walking test(Assessed 0-4 days before intervention, 0-4 days after ended intervention assessment and 3 months after ended intervention)