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Effects of Physical Training in iNPH (iNPhys)

Primary Purpose

Hydrocephalus, Normal Pressure

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
High Intensive Functional Exercise (HIFE)
Physical training advice
Sponsored by
Linkoeping University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hydrocephalus, Normal Pressure focused on measuring Exercise Therapy

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dept of Neurology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High-intensity physical exercise, HIFE

Physical training advice

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
January 12, 2016
Last Updated
March 6, 2020
Sponsor
Linkoeping University
Collaborators
Sahlgrenska University Hospital, Sweden
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1. Study Identification

Unique Protocol Identification Number
NCT02659111
Brief Title
Effects of Physical Training in iNPH
Acronym
iNPhys
Official Title
Effects of Physical Training in Shunt-operated Patients With Idiopathic Normal Pressure Hydrocephalus
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
June 2019 (Actual)
Study Completion Date
January 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Linkoeping University
Collaborators
Sahlgrenska University Hospital, Sweden

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hydrocephalus, Normal Pressure
Keywords
Exercise Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
127 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High-intensity physical exercise, HIFE
Arm Type
Experimental
Arm Title
Physical training advice
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
High Intensive Functional Exercise (HIFE)
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Physical training advice
Intervention Description
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 Outcome Measure Information:
Title
Change in iNPH-scale
Description
iNPH-scale (Hellström et al) is a validated scale consisting of four domains; balance, gait, cognition and micturition to evaluate severity of iNPH.
Time Frame
3 and 6 months postoperatively
Title
Change in GAS
Description
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.
Time Frame
3 and 6 months postoperatively
Secondary Outcome Measure Information:
Title
Quality of life
Description
EQ-5D-5L
Time Frame
3 and 6 months postoperatively
Title
Depression
Description
Beck Depression Inventory II
Time Frame
3 and 6 months postoperatively
Title
Disability
Description
Modified Rankin Scale
Time Frame
3 and 6 months postoperatively
Title
Muscle strengths
Description
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.
Time Frame
3 and 6 months postoperatively
Title
Physical endurance test
Description
Testing the distance a person is able to walk in 6 min
Time Frame
3 and 6 months postoperatively
Title
Falls
Description
Registration of the actual number of falls in the last three months
Time Frame
3 and 6 months postoperatively
Title
Actigraphy
Description
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.
Time Frame
3 and 6 months postoperatively
Title
Balance
Description
Timed Up and Go
Time Frame
3 and 6 months postoperatively
Title
ADL
Description
ADL taxonomy
Time Frame
3 and 6 months postoperatively
Title
Activity
Description
Grimby 6
Time Frame
3 and 6 months postoperatively
Title
Life satisfaction
Description
LiSat 11 is a validated questionnaire with 11 items concerning different aspects of quality of life,.
Time Frame
3 and 6 months postoperatively
Title
Diurnal rhythm
Description
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.
Time Frame
3 and 6 months postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fredrik Lundin, MD, PhD
Organizational Affiliation
Dept of Neurology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept of Neurology
City
Linköping
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
35418936
Citation
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.
Results Reference
derived
PubMed Identifier
34809666
Citation
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.
Results Reference
derived

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Effects of Physical Training in iNPH

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