Physical exercise and goal attainment after shunt surgery in idiopathic normal pressure hydrocephalus: a randomised clinical trial

Abstract Background 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 physic...

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Autores principales: Johanna Rydja, Lena Kollén, Per Hellström, Katarina Owen, Åsa Lundgren Nilsson, Carsten Wikkelsø, Mats Tullberg, Fredrik Lundin
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Publicado: BMC 2021
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spelling oai:doaj.org-article:f00ea7cdd09a4666a37f8b7bf2c685862021-11-28T12:04:41ZPhysical exercise and goal attainment after shunt surgery in idiopathic normal pressure hydrocephalus: a randomised clinical trial10.1186/s12987-021-00287-82045-8118https://doaj.org/article/f00ea7cdd09a4666a37f8b7bf2c685862021-11-01T00:00:00Zhttps://doi.org/10.1186/s12987-021-00287-8https://doaj.org/toc/2045-8118Abstract Background 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. Methods This 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. Results In 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. Conclusions An 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/NCT02659111Johanna RydjaLena KollénPer HellströmKatarina OwenÅsa Lundgren NilssonCarsten WikkelsøMats TullbergFredrik LundinBMCarticleIdiopathic normal pressure hydrocephalusNeurosurgical proceduresRehabilitationExerciseNeurology. Diseases of the nervous systemRC346-429ENFluids and Barriers of the CNS, Vol 18, Iss 1, Pp 1-11 (2021)
institution DOAJ
collection DOAJ
language EN
topic Idiopathic normal pressure hydrocephalus
Neurosurgical procedures
Rehabilitation
Exercise
Neurology. Diseases of the nervous system
RC346-429
spellingShingle Idiopathic normal pressure hydrocephalus
Neurosurgical procedures
Rehabilitation
Exercise
Neurology. Diseases of the nervous system
RC346-429
Johanna Rydja
Lena Kollén
Per Hellström
Katarina Owen
Åsa Lundgren Nilsson
Carsten Wikkelsø
Mats Tullberg
Fredrik Lundin
Physical exercise and goal attainment after shunt surgery in idiopathic normal pressure hydrocephalus: a randomised clinical trial
description Abstract Background 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. Methods This 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. Results In 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. Conclusions An 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
format article
author Johanna Rydja
Lena Kollén
Per Hellström
Katarina Owen
Åsa Lundgren Nilsson
Carsten Wikkelsø
Mats Tullberg
Fredrik Lundin
author_facet Johanna Rydja
Lena Kollén
Per Hellström
Katarina Owen
Åsa Lundgren Nilsson
Carsten Wikkelsø
Mats Tullberg
Fredrik Lundin
author_sort Johanna Rydja
title Physical exercise and goal attainment after shunt surgery in idiopathic normal pressure hydrocephalus: a randomised clinical trial
title_short Physical exercise and goal attainment after shunt surgery in idiopathic normal pressure hydrocephalus: a randomised clinical trial
title_full Physical exercise and goal attainment after shunt surgery in idiopathic normal pressure hydrocephalus: a randomised clinical trial
title_fullStr Physical exercise and goal attainment after shunt surgery in idiopathic normal pressure hydrocephalus: a randomised clinical trial
title_full_unstemmed Physical exercise and goal attainment after shunt surgery in idiopathic normal pressure hydrocephalus: a randomised clinical trial
title_sort physical exercise and goal attainment after shunt surgery in idiopathic normal pressure hydrocephalus: a randomised clinical trial
publisher BMC
publishDate 2021
url https://doaj.org/article/f00ea7cdd09a4666a37f8b7bf2c68586
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