Clinical trial NCT02659111: Effects of Physical Training in iNPH
Official title: Effects of Physical Training in Shunt-operated Patients With Idiopathic Normal Pressure Hydrocephalus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hydrocephalus, Normal Pressure
Keywords: Exercise Therapy
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
Collaborators: name: Sahlgrenska University Hospital
First posted: 2016-01-20
Enrollment: 127
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in iNPH-scale
timeFrame: 3 and 6 months postoperatively
measure: Change in GAS
timeFrame: 3 and 6 months postoperatively
Secondary outcomes:
measure: Quality of life
timeFrame: 3 and 6 months postoperatively
measure: Depression
timeFrame: 3 and 6 months postoperatively
measure: Disability
timeFrame: 3 and 6 months postoperatively
measure: Muscle strengths
timeFrame: 3 and 6 months postoperatively
measure: Physical endurance test
timeFrame: 3 and 6 months postoperatively
measure: Falls
timeFrame: 3 and 6 months postoperatively
measure: Actigraphy
timeFrame: 3 and 6 months postoperatively
measure: Balance
timeFrame: 3 and 6 months postoperatively
measure: ADL
timeFrame: 3 and 6 months postoperatively
measure: Activity
timeFrame: 3 and 6 months postoperatively
measure: Life satisfaction
timeFrame: 3 and 6 months postoperatively
measure: Diurnal rhythm
timeFrame: 3 and 6 months postoperatively
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Dept of Neurology
Study officials:
affiliation: Dept of Neurology
name: Fredrik Lundin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.