Effects of Physical Training in iNPH

Hydrocephalus, Normal Pressure Clinical Trial

— iNPhys  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02659111
• Other study ID #: Dnr 205/250-31
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: January 2020

Study information

• Verified date: March 2020
• Source: Linkoeping University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: January 2020
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hydrocephalus
• Hydrocephalus, Normal Pressure

Intervention

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
• 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.

Locations

Country	Name	City	State
Sweden	Dept of Neurology	Linköping

Sponsors (2)

Lead Sponsor	Collaborator
Linkoeping University	Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

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