Multicentre, randomised controlled trial of PDSAFE, a physiotherapist-delivered fall prevention programme for people with Parkinson's

Kim Chivers Seymour; Ruth Pickering; Lynn Rochester; Helen C Roberts; Claire Ballinger; Sophia Hulbert; Dorit Kunkel; Ioana R Marian; Carolyn Fitton; Emma McIntosh; Victoria A Goodwin; Alice Nieuwboer; Sarah E Lamb; Ann Ashburn

doi:10.1136/jnnp-2018-319448

Multicentre, randomised controlled trial of PDSAFE, a physiotherapist-delivered fall prevention programme for people with Parkinson's

J Neurol Neurosurg Psychiatry. 2019 Jul;90(7):774-782. doi: 10.1136/jnnp-2018-319448. Epub 2019 Apr 3.

Authors

Affiliations

¹ School of Health Sciences, University of Southampton, Southampton, UK.
² Faculty of Medicine, University of Southampton, Southampton, UK.
³ Institute of Neuroscience, Newcastle University, Newcastle upon Tyne, United Kingdom.
⁴ HEHTA, University of Glasgow, Glasgow, UK.
⁵ College of Medicine, University of Exeter, Exeter, UK.
⁶ Department of Rehabilitation Sciences, KU Leuven, Leuven, Belgium.
⁷ Oxford Clinical Trials Research Unit, University of Oxford, Oxford, UK.
⁸ School of Health Sciences, University of Southampton, Southampton, UK ann@soton.ac.uk.

Abstract

Objective: To estimate the effect of a physiotherapist-delivered fall prevention programme for people with Parkinson's (PwP).

Methods: People at risk of falls with confirmed Parkinson's were recruited to this multicentre, pragmatic, investigator blind, individually randomised controlled trial with prespecified subgroup analyses. 474 PwP (Hoehn and Yahr 1-4) were randomised: 238 allocated to a physiotherapy programme and 236 to control. All participants had routine care; the control group received a DVD about Parkinson's and single advice session at trial completion. The intervention group (PDSAFE) had an individually tailored, progressive home-based fall avoidance strategy training programme with balance and strengthening exercises. The primary outcome was risk of repeat falling, collected by self-report monthly diaries, 0-6 months after randomisation. Secondary outcomes included Mini-BESTest for balance, chair stand test, falls efficacy, freezing of gait, health-related quality of life (EuroQol EQ-5D), Geriatric Depression Scale, Physical Activity Scale for the Elderly and Parkinson's Disease Questionnaire, fractures and rate of near falling.

Results: Average age is 72 years and 266 (56%) were men. By 6 months, 116 (55%) of the control group and 125 (61.5%) of the intervention group reported repeat falls (controlled OR 1.21, 95% CI 0.74 to 1.98, p=0.447). Secondary subgroup analyses suggested a different response to the intervention between moderate and severe disease severity groups. Balance, falls efficacy and chair stand time improved with near falls reduced in the intervention arm.

Conclusion: PDSAFE did not reduce falling in this pragmatic trial of PwP. Other functional tasks improved and reduced fall rates were apparent among those with moderate disease.

Trial registration number: ISRCTN48152791.

Keywords: Cognition; Disease severity; Fall prevention; Freezing of gait; Parkinson's; Physiotherapy.

Publication types

Multicenter Study
Pragmatic Clinical Trial
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Accidental Falls / prevention & control*
Aged
Aged, 80 and over
Exercise Therapy / methods
Female
Humans
Male
Middle Aged
Parkinson Disease / complications
Parkinson Disease / therapy*
Physical Therapy Modalities*
Postural Balance
Quality of Life
Resistance Training / methods

Grants and funding

WT_/Wellcome Trust/United Kingdom