Equivalence Test of Two Different Inspiratory Muscle Training Protocols: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Maximal inspiratory pressure
研究概览
简要总结
The objective of this study is to investigate if six weeks of high intensity Inspiratory Muscle Training (IMT) performed two times a week has the same effect as five times a week in hospitalized patients with first time Spinal Cord Injury (SCI).
Design/ methods: A Randomised controlled trial (RCT) including 60 patients, with reduced Maximal Inspiration Pressure (MIP) will be recruited at two specialized SCI centers in Denmark. Primary outcome is MIP after six weeks of training. Secondary outcome will be reported on Rating Perceived Exertion (RPE), voice performance, Quality Of Life (QOL)and sleep quality. Furthermore, long term follow-up at 12 months after start of intervention will also be performed.
详细描述
Background: SCI may result in various disabilities including both physical, cognitive, emotional and social domains. Motor function and function of the respiratory muscles are often decreased and may influence the patient's activities of daily activities and QOL. IMT is training to improve the strength and endurance of diaphragm and the external intercostal muscles. Various training protocols of IMT have shown efficient to increase lung function. Although, a recent meta-analysis suggest that high intensity training may be more efficient it is less clear at what weekly frequency IMT should be performed.
Thus, the objective of this study is to investigate if six weeks of high intensity IMT performed two times a week has the same effect as five times a week in hospitalized patients with first time SCI.
Design/ methods: A Randomised controlled trial (RCT) including 60 patients, with reduced MIP will be recruited at two specialized SCI centers in Denmark. Primary outcome is MIP after six weeks of training. Secondary outcome will be reported on end of treatment and long term follow-up (12 months after start of intervention) in RPE, voice performance, QOL and sleep quality. The two intervention arms will consist of one arm training two times a week and the other arm training five times a week. The training protocol in both arms will include five rounds of IMT with 12 repetitions at 60 % of MIP. MIP will be increased 10 % every week if tolerated by the patient until 80 % of MIP is reached. After six weeks patients are motivated to continue training by themself up to 12 months after start of intervention.
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
Outcome assessors will be blinded to group allocation.
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 SCI within 0-6 months
- •Age ≥ 18 years
- •Neurological level: C4 -TH12 and C1-C4 (AIS D only)
- •Severity/ AIS: A, B, C or D
- •Able to give informed concent and understand and read Danish
- •Mental able to understand and participate in a lung function assessment
- •Decreased MIP according to normal gender and age adjusted MIP values
排除标准
- •Lung disease or lung infection at the time of inclusion
- •Co-morbidity or other contra indications
- •Injury that hinder mouth shutting
- •Respirator or tracheal tube use
- •Experience of severe dizziness or vomiting during training
- •Not expected to be hospitalised for at least 6 weeks
结局指标
主要结局
Maximal inspiratory pressure
时间窗: Change from baseline assessment (0-4 days before treatment start) to End of treatment assessment (6 weeks after intervention start)
MIP is an objective measurement that indirectly describe the inspiratory muscle strength
次要结局
- Experienced quality of life measured with the The basic Spinal cord injury (SCI) Data Set for Qualify of Life(Baseline assessment (0-4 days before treatment start), End of treatment assessment (6 weeks after intervention start) Longterm follow up (12 months after intervention start))
- Voice performance(Baseline assessment (0-4 days before treatment start), End of treatment assessment (6 weeks after intervention start) Longterm follow up (12 months after intervention start))
- Experienced sleep Quality measured with Pittsburgh Sleep Quality Index (PSQI) tool(Baseline assessment (0-4 days before treatment start), End of treatment assessment (6 weeks after intervention start) Longterm follow up (12 months after intervention start))
- Rating of Perceived Exertion(Baseline assessment (0-4 days before treatment start), End of treatment assessment (6 weeks after intervention start) Longterm follow up (12 months after intervention start))
- Maximal inspiratory pressure(Change from baseline assessment (0-4 days before treatment start) to longterm follow up (12 months after intervention start))
- Patients' Global Impression of Change (PGIC) scale(collected at 6 week and 12 months after start of the intervention)