Abstract
BackgroundRehabilitation in iNPH is suggested to be an important factor to improve patients’ functions but there are lack of clinical trials evaluating the effect of rehabilitation interventions after shunt surgery in iNPH. The objective of this study was to evaluate the effect of a physical exercise programme and goal attainment for patients with idiopathic normal pressure hydrocephalus (iNPH) after surgery compared to a control group.MethodsThis was a dual centre randomised controlled trial with assessor blinding, intention-to-treat (ITT) and per protocol (PP) analysis. Individuals diagnosed with iNPH scheduled to undergo shunt surgery at the Linköping University Hospital in Linköping and Sahlgrenska University Hospital in Gothenburg, Sweden were consecutively eligible for inclusion. Inclusion was conducted between January 2016 and June 2018. The patients were randomised 1:1 using sequentially numbered sealed envelopes to receive either written exercise information (control group) or written information and an additional supervised high-intensity, functional exercise programme (HIFE) executed twice weekly over 12 weeks (exercise group). Preoperatively, the patients set individual goals. The primary outcome was change from baseline in the total iNPH scale score at the post-intervention follow-up. Secondary outcomes were goal attainment, and change in the separate scores of gait, balance, neuropsychology and continence and in the total score after 6 months.ResultsIn total, 127 participants were randomised to the exercise group (n = 62) and to the control group (n = 65). In the ITT population (exercise group, n = 50; control group, n = 59), there were no between-group differences in the primary outcome, but the attrition rate in the exercise group was high. The exercise group improved more than the control group in the balance domain scores after 6 months. Post-intervention, the PP exercise population achieved their set goals to a greater extent than the controls.ConclusionsAn additional effect of the 12-week HIFE-programme on the overall improvement according to the iNPH-scale after shunt surgery in iNPH was not shown. This could be due to high attrition rate. However, the long-term effect on balance and higher goal achievement indicate beneficial influences of supervised physical exercise.Trial registration clinicaltrials.gov, NCT02659111. Registered 20 January 2016, https://clinicaltrials.gov/ct2/show/NCT02659111
Highlights
The core clinical symptoms in idiopathic normal pressure hydrocephalus are impaired gait in combination with a disturbed balance [1,2,3] often in conjunction with cognitive impairment and incontinence [4]
Fifty individuals in the exercise group and 59 in the control group were available for the ITT follow-up analysis at the end of the intervention
Twelve participants in the exercise group were lost to the follow-up assessment; two died due to a subdural haematoma, one moved abroad, four had subdural haematomas treated with an elevated valve opening pressure setting, one had a distal shunt catheter dysfunction, one had a shunt infection and three participants withdrew their consent
Summary
The core clinical symptoms in idiopathic normal pressure hydrocephalus (iNPH) are impaired gait in combination with a disturbed balance [1,2,3] often in conjunction with cognitive impairment and incontinence [4]. Rehabilitation in iNPH is suggested to be an important factor to improve patients’ functions but there are lack of clinical trials evaluating the effect of rehabilitation interventions after shunt surgery in iNPH. The objective of this study was to evaluate the effect of a physical exercise programme and goal attainment for patients with idiopathic normal pressure hydrocephalus (iNPH) after surgery compared to a control group. There were no betweengroup differences regarding change in the total iNPH scale scores from baseline at any of the follow-up sessions. In the secondary ITT analysis of each iNPH scale domain, the exercise group had higher balance domain scores than the control group at 6 months. For all other domains there were no between-group differences, both the exercise group and the control group significantly improved in all separate domains compared to baseline at the two follow-up sessions (Fig. 2, Additional File 3)
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