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Completed

NCT Number: NCT02659111

Effects of Physical Training in iNPH

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept of Neurology

Linköping, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High Intensive Functional Exercise (HIFE)

Other

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

Physical training advice

Other

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Quality of life

    Time frame: 3 and 6 months postoperatively

    EQ-5D-5L

  2. Depression

    Time frame: 3 and 6 months postoperatively

    Beck Depression Inventory II

  3. Disability

    Time frame: 3 and 6 months postoperatively

    Modified Rankin Scale

  4. 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.

  5. Physical endurance test

    Time frame: 3 and 6 months postoperatively

    Testing the distance a person is able to walk in 6 min

  6. Falls

    Time frame: 3 and 6 months postoperatively

    Registration of the actual number of falls in the last three months

  7. 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.

  8. Balance

    Time frame: 3 and 6 months postoperatively

    Timed Up and Go

  9. ADL

    Time frame: 3 and 6 months postoperatively

    ADL taxonomy

  10. Activity

    Time frame: 3 and 6 months postoperatively

    Grimby 6

  11. 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,.

  12. 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.

Sponsors and collaborators

Lead sponsor

Linkoeping University

Other Gov

Collaborators

  • Sahlgrenska University Hospital

Registry information

Official study title

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

Acronym: iNPhys

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Jan 20, 2016
Registry last updated
Mar 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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