Effects of Physical Training in iNPH (iNPhys)

• ClinicalTrials.gov Identifier: NCT02659111
• Recruitment Status: Completed
• First Posted: January 20, 2016
• Last Update Posted: March 9, 2020
• Sponsor: Linkoeping University
• Collaborator: Sahlgrenska University Hospital, Sweden
• Information provided by (Responsible Party): Fredrik Lundin, Linkoeping University

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Hydrocephalus, Normal Pressure	Other: High Intensive Functional Exercise (HIFE); Other: Physical training advice	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 127 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effects of Physical Training in Shunt-operated Patients With Idiopathic Normal Pressure Hydrocephalus
• Actual Study Start Date: January 2016
• Actual Primary Completion Date: June 2019
• Actual Study Completion Date: January 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 40 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Sweden

Dept of Neurology

Linköping, Sweden

Sponsors and Collaborators

Linkoeping University

Sahlgrenska University Hospital, Sweden

Investigators

• Principal Investigator: Fredrik Lundin, MD, PhD; Dept of Neurology

More Information

• Responsible Party: Fredrik Lundin, MD, PhD, Linkoeping University
• ClinicalTrials.gov Identifier: NCT02659111
• Other Study ID Numbers: Dnr 205/250-31
• First Posted: January 20, 2016
• Last Update Posted: March 9, 2020
• Last Verified: March 2020

Keywords provided by Fredrik Lundin, Linkoeping University:

Exercise Therapy

Additional relevant MeSH terms:

Hydrocephalus; Hydrocephalus, Normal Pressure; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases