Effects of Physical Training in iNPH (iNPhys)

Linköping University (LiU)

Status: Completed

Conditions: Hydrocephalus, Normal Pressure

Treatments: Other: High Intensive Functional Exercise (HIFE); Other: Physical training advice

Study type: Interventional

Funder types: Other

Identifiers

NCT02659111

Dnr 205/250-31

Details and patient eligibility

About

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.

Full 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.

Enrollment: 127 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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127 participants in 2 patient groups

High-intensity physical exercise, HIFE

Experimental group

Treatment:

Other: Physical training advice

Other: High Intensive Functional Exercise (HIFE)

Physical training advice

Active Comparator group

Treatment:

Other: Physical training advice