Effects of Physical Training in iNPH
- Conditions
- Hydrocephalus, Normal Pressure
- Interventions
- Other: Physical training adviceOther: High Intensive Functional Exercise (HIFE)
- Registration Number
- NCT02659111
- Lead Sponsor
- Linkoeping University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 127
Shunt-operated patients with Idiopathic Normal Pressure Hydrocephalus diagnosed according the international guidelines from 2005
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Physical training advice Physical training advice - High-intensity physical exercise, HIFE Physical training advice - High-intensity physical exercise, HIFE High Intensive Functional Exercise (HIFE) -
- Primary Outcome Measures
Name Time Method Change in iNPH-scale 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 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.
- Secondary Outcome Measures
Name Time Method Disability 3 and 6 months postoperatively Modified Rankin Scale
Quality of life 3 and 6 months postoperatively EQ-5D-5L
Muscle strengths 3 and 6 months postoperatively The test is called "Chair-stand test". Leg strengths is measured, by counting number of raising ups from sitting to standing, that the research person is able to in 30 sec.
Physical endurance test 3 and 6 months postoperatively Testing the distance a person is able to walk in 6 min
Balance 3 and 6 months postoperatively Timed Up and Go
Depression 3 and 6 months postoperatively Beck Depression Inventory II
Falls 3 and 6 months postoperatively Registration of the actual number of falls in the last three months
Actigraphy 3 and 6 months postoperatively Actigraphy is a method to evaluate physical activity in a research person´s normal life. SenseWear is used to record number of steps daily but also time spent lying and standing which will give information about the activity.
ADL 3 and 6 months postoperatively ADL taxonomy
Activity 3 and 6 months postoperatively Grimby 6
Diurnal rhythm 3 and 6 months postoperatively Actigraphy (SenseWear) is used for one week. Diurnal rhythm will be assessed by measuring the peak amplitude of acitivity daily, the mean amplitude of activity daily and the 24 hour period.
Life satisfaction 3 and 6 months postoperatively LiSat 11 is a validated questionnaire with 11 items concerning different aspects of quality of life,.
Trial Locations
- Locations (1)
Dept of Neurology
🇸🇪Linköping, Sweden