NCT02659111

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 12, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 20, 2016

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

March 9, 2020

Status Verified

March 1, 2020

Enrollment Period

3.4 years

First QC Date

January 12, 2016

Last Update Submit

March 6, 2020

Conditions

Hydrocephalus, Normal Pressure

Keywords

Exercise Therapy

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (12)

  • Quality of life

    3 and 6 months postoperatively

  • Depression

    3 and 6 months postoperatively

  • Disability

    3 and 6 months postoperatively

  • Muscle strengths

    3 and 6 months postoperatively

  • Physical endurance test

    3 and 6 months postoperatively

  • +7 more secondary outcomes

Study Arms (2)

High-intensity physical exercise, HIFE

EXPERIMENTAL
Other: High Intensive Functional Exercise (HIFE)Other: Physical training advice

Physical training advice

ACTIVE COMPARATOR
Other: Physical training advice

Interventions

High Intensive Functional Exercise (HIFE)OTHER

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

High-intensity physical exercise, HIFE
Physical training adviceOTHER

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.

High-intensity physical exercise, HIFEPhysical training advice

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Shunt-operated patients with Idiopathic Normal Pressure Hydrocephalus diagnosed according the international guidelines from 2005

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of Neurology

Linköping, Sweden

Location

Related Publications (2)

  • 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.

    PMID: 35418936DERIVED

  • 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.

    PMID: 34809666DERIVED

MeSH Terms

Conditions

Hydrocephalus, Normal Pressure

Condition Hierarchy (Ancestors)

HydrocephalusBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Fredrik Lundin, MD, PhD

    Dept of Neurology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

January 12, 2016

First Posted

January 20, 2016

Study Start

January 1, 2016

Primary Completion

June 1, 2019

Study Completion

January 1, 2020

Last Updated

March 9, 2020

Record last verified: 2020-03

Locations

SE(1)