Effects of Physical Training in Shunt-operated Patients With Idiopathic Normal Pressure Hydrocephalus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 127
- 试验地点
- 1
- 主要终点
- Change in iNPH-scale
研究概览
简要总结
Patients with idiopathic Normal Pressure Hydrocephalus (iNPH) have variable difficulties regarding gait, balance, cognition and micturition. A shunt operation will improve these difficulties in most cases. Data suggest however, that they do not change their physical activity postoperatively. Physical training has been shown to be beneficial in patients with similar diseases i.e. Parkinson. The aim of this study is to apply a high intensity physical training program after a shunt operation to see if the patients can improve their physical capacity and ambulatory activity more than patients who only receive standardized written advice about physical training.
详细描述
Consecutive patients with iNPH at the neurological departments of University Hospital of Linköping and at Sahlgrenska University Hospital are included and randomized for either physical training according to a validated training concept for elderly and cognitive impaired patients named HIFE ( High Intensity Functional Exercise) together with a standardized written instruction for home training of physical exercises or only a standardized written instruction for home training. Goal Attainment Scaling will be used to set measurable goals together with the patient. The training will take place in a facility where physiotherapists are available either at the two centers or close to the patient´s home.Those physiotherapists at the centers responsible for the training will contact and send the local physiotherapists a manual and give instructions about the HIFE concept and will also stay in contact for the whole intervention i.e. 12 weeks ( one hour two times a week). A minimum of 18 out of 24 session will be required.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Shunt-operated patients with Idiopathic Normal Pressure Hydrocephalus diagnosed according the international guidelines from 2005
排除标准
- •MMSE: equal to and below 16 and/or inability to walk, with or without support , for 10 m.
- •Other disease, e.g severe heart disease, asthma making intensive physical training impossible.
结局指标
主要结局
Change in iNPH-scale
时间窗: 3 and 6 months postoperatively
iNPH-scale (Hellström et al) is a validated scale consisting of four domains; balance, gait, cognition and micturition to evaluate severity of iNPH.
Change in GAS
时间窗: 3 and 6 months postoperatively
Goal Attainment Scaling. A goal i set and an assessment is made according to a five-graded scale defining in what degree the goal is achieved.
次要结局
- Disability(3 and 6 months postoperatively)
- Quality of life(3 and 6 months postoperatively)
- Muscle strengths(3 and 6 months postoperatively)
- Physical endurance test(3 and 6 months postoperatively)
- Balance(3 and 6 months postoperatively)
- Depression(3 and 6 months postoperatively)
- Falls(3 and 6 months postoperatively)
- Actigraphy(3 and 6 months postoperatively)
- ADL(3 and 6 months postoperatively)
- Activity(3 and 6 months postoperatively)
- Diurnal rhythm(3 and 6 months postoperatively)
- Life satisfaction(3 and 6 months postoperatively)
研究者
Fredrik Lundin
MD, PhD
Linkoeping University