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Effects of Physical Training in iNPH (iNPhys)

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ClinicalTrials.gov Identifier: NCT02659111
Recruitment Status : Recruiting
First Posted : January 20, 2016
Last Update Posted : March 7, 2018
Sponsor:
Collaborator:
Sahlgrenska University Hospital, Sweden
Information provided by (Responsible Party):
Fredrik Lundin, Linkoeping University

January 12, 2016
January 20, 2016
March 7, 2018
January 2016
December 2018   (Final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT02659111 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Effects of Physical Training in iNPH
Effects of Physical Training in Shunt-operated Patients With Idiopathic Normal Pressure Hydrocephalus
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.
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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hydrocephalus, Normal Pressure
  • Other: High Intensive Functional Exercise (HIFE)
    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
  • Other: Physical training advice
    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.
  • Experimental: High-intensity physical exercise, HIFE
    Interventions:
    • Other: High Intensive Functional Exercise (HIFE)
    • Other: Physical training advice
  • Active Comparator: Physical training advice
    Intervention: Other: Physical training advice
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
128
Same as current
June 2019
December 2018   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
40 Years and older   (Adult, Older Adult)
No
Contact: Fredrik Lundin, MD, PhD +46704782816 Fredrik.Lundin@regionostergotland.se
Contact: Mats Tullberg, MD, PhD +46702429255 mats.tullberg@neuro.gu.se
Sweden
 
 
NCT02659111
Dnr 205/250-31
No
Not Provided
Not Provided
Fredrik Lundin, Linkoeping University
Linkoeping University
Sahlgrenska University Hospital, Sweden
Principal Investigator: Fredrik Lundin, MD, PhD Dept of Neurology
Linkoeping University
March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP