A multicentre, randomised controlled trial of PDSAFE, a physiotherapist-delivered fall prevention programme for people with Parkinson’s

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 multi-centre, pragmatic, investigator blind, individually randomised controlled trial with pre-specified sub-group 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 to 6 months post-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, 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 odds ratio 1.21, 95% confidence interval 0.74 to 1.98, P=0.447). Secondary sub-group 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.