Effects of Physical Training in iNPH

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Physical Training in Shunt-operated Patients With Idiopathic Normal Pressure Hydrocephalus

Conditions
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Hydrocephalus, Normal Pressure

Intervention / Treatment
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* Other: High Intensive Functional Exercise (HIFE)
* Other: Physical training advice


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Shunt-operated patients with Idiopathic Normal Pressure Hydrocephalus diagnosed according the international guidelines from 2005 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-intensity physical exercise, HIFE<br> | Other: High Intensive Functional Exercise (HIFE)<br>* Patients invited to high-intensity physical exercise, HIFE by a physiotherapist with special competence in neurology at one of the two centers, or by a general physiotherapist where the patient lives. Goal Attainment Scaling is performed. The training will be given twice a week for one hour during 12 weeks . At least 18 of 24 training session in a four month period of time will be required. A training manual will be distributed to each training physiotherapist. The patients will also be encouraged to do additional training and they will receive standardized written physical training advice<br>Other: Physical training advice<br>* Patients randomized to written advice for physical training will be given a leaflet with instructions how to train by there own.The physiotherapist responsible for evaluating sets goals together with the patient according to Goal Attainment Scaling.<br>|
| Active Comparator: Physical training advice<br> | Other: Physical training advice<br>* Patients randomized to written advice for physical training will be given a leaflet with instructions how to train by there own.The physiotherapist responsible for evaluating sets goals together with the patient according to Goal Attainment Scaling.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in iNPH-scale | iNPH-scale (Hellström et al) is a validated scale consisting of four domains; balance, gait, cognition and micturition to evaluate severity of iNPH. | 3 and 6 months postoperatively | 
| Change in GAS | 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. | 3 and 6 months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | EQ-5D-5L | 3 and 6 months postoperatively | 
| Depression | Beck Depression Inventory II | 3 and 6 months postoperatively | 
| Disability | Modified Rankin Scale | 3 and 6 months postoperatively | 
| Muscle strengths | 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. | 3 and 6 months postoperatively | 
| Physical endurance test | Testing the distance a person is able to walk in 6 min | 3 and 6 months postoperatively | 
| Falls | Registration of the actual number of falls in the last three months | 3 and 6 months postoperatively | 
| Actigraphy | 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. | 3 and 6 months postoperatively | 
| Balance | Timed Up and Go | 3 and 6 months postoperatively | 
| ADL | ADL taxonomy | 3 and 6 months postoperatively | 
| Activity | Grimby 6 | 3 and 6 months postoperatively | 
| Life satisfaction | LiSat 11 is a validated questionnaire with 11 items concerning different aspects of quality of life,. | 3 and 6 months postoperatively | 
| Diurnal rhythm | 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. | 3 and 6 months postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise Therapy