Effects of Physical Training in iNPH (iNPhys)

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.

Study Overview

• Status: Completed
• Conditions: Hydrocephalus, Normal Pressure
• Intervention / Treatment: Other: High Intensive Functional Exercise (HIFE); Other: Physical training advice

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 127
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Linköping, Sweden
    • Dept Of Neurology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High-intensity physical exercise, HIFE	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.
Active Comparator: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Linkoeping University
• Collaborators: Sahlgrenska University Hospital, Sweden
• Investigators: Principal Investigator: Fredrik Lundin, MD, PhD, Dept Of Neurology

Publications and helpful links

General Publications

• Rydja J, Kollen L, Ulander M, Tullberg M, Lundin F. Physical Capacity and Activity in Patients With Idiopathic Normal Pressure Hydrocephalus. Front Neurol. 2022 Mar 28;13:845976. doi: 10.3389/fneur.2022.845976. eCollection 2022.
• Rydja J, Kollen L, Hellstrom P, Owen K, Lundgren Nilsson A, Wikkelso C, Tullberg M, Lundin F. Physical exercise and goal attainment after shunt surgery in idiopathic normal pressure hydrocephalus: a randomised clinical trial. Fluids Barriers CNS. 2021 Nov 22;18(1):51. doi: 10.1186/s12987-021-00287-8.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): January 1, 2020

Study Registration Dates

• First Submitted: January 12, 2016
• First Submitted That Met QC Criteria: January 14, 2016
• First Posted (Estimate): January 20, 2016

Study Record Updates

• Last Update Posted (Actual): March 9, 2020
• Last Update Submitted That Met QC Criteria: March 6, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Exercise Therapy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hydrocephalus; Hydrocephalus, Normal Pressure
• Other Study ID Numbers: Dnr 205/250-31