Inspiratory Muscle Training in Patients With End Stage Renal Failure: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Maximal inspiratory pressure (MIP)
研究概览
简要总结
This study will investigate whether inspiratory muscle training in patients with end stage renal failure can improve strength and function.
详细描述
Patients with chronic renal failure commonly have weak respiratory muscles leading to problems in everyday activities and respiratory infections.
This project aims to investigate if threshold inspiratory muscle training improves the strength, everyday function and participation of patients on haemodialysis. Forty eight patients will be recruited in a randomized controlled trial of inspiratory muscle training vs sham training.
Outcome measures include the maximal inspiratory pressure and the Frenchay activities index. Initial data will be collected by a blinded assessor; the patients will train at 40 % of initial maximal inspiratory pressure for six weeks and be reassessed. If the inspiratory muscle training is effective, it will improve both the physical and functional components of the patient's lives and be recommended for all renal patients.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •documented chronic renal failure
- •attending either haemodialysis or pre-dialysis clinic
- •English speaking
- •no prior experience with inspiratory training devices.
排除标准
- •lung collagen disorders
- •renal diseases associated with autoimmune pulmonary diseases
- •current pleural effusion
- •pulmonary oedema
- •decreased conscious level
- •behavioural disturbances
- •unable or refused to give consent
- •taking medications that influence respiratory muscle function (e.g. steroids or cyclophosphamide)
结局指标
主要结局
Maximal inspiratory pressure (MIP)
时间窗: Change between baseline (enrolment) and 6 weeks
American Thoracic Society standards
次要结局
- Frenchay activities index(Change between baseline (enrolment) and 6 weeks)