Clinical Trial: Effects of Physical Training in iNPH

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Linkoeping University

Current Primary Outcome:

  • Change in iNPH-scale [ Time Frame: 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 [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Linkoeping University

Dates:
Date Received: January 12, 2016
Date Started: January 2016
Date Completion: June 2018
Last Updated: September 6, 2016
Last Verified: September 2016