Objective: The aim was to examine the effectiveness of an exercise and strategy based intervention (PDSAFE) for fall reduction.

Background: Evidence suggests exercise-based interventions might reduce fall risk although research findings were inconclusive. This is the largest trial on fall prevention for people with Parkinson’s.

Methods: People with a confirmed diagnosis of Parkinson’s at risk of falls were randomly allocated to a two-group multi-centred, community-based (1:1) controlled trial. PDSAFE, individually tailored and structured around functional fall avoidance strategies with balance and strengthening exercises was delivered by physiotherapists in the home. The primary outcome was risk of repeat falling between 0-6 months post-randomisation using self-completed monthly falls diaries. Secondary outcomes assessed blind included: balance (Mini-BESTest); functional strength (chair stand test), disease severity (UPDRS and H&Y); falls efficacy (FES); freezing (new Freezing of Gait (NFoG) questionnaire).

Results: 541 participants were screened and recruited to pre-randomisation monitoring, 474 participants (56% male; mean age 72 years; Hoehn & Yahr 1-4) were randomised to intervention (238) or control (236). No difference in repeat falling within 6 months of randomisation was found (PDSAFE to control odds ratio 1.21, 95% CI 0.74 to 1.98, P=0.447). Secondary analysis demonstrated better balance (Mini-BESTest mean difference 0.95, 95%CI 0.24 to 1.67, P=0.009) and balance confidence (FES-I mean difference 1.6, 95% CI -3.0 to -0.19, P=0.026), in addition near-falling was reduced with PDSAFE (odds ratio 0.67, 95%CI 0.53 to 0.86, P=0.001) at 6 months. Pre-specified subgroup analysis revealed a varied PDSAFE effect according to UPDRS at baseline (P=0.009) and retrospective falling recorded at trial entry (P=0.050) with decreased falling among those in the moderate group and increased repeat falling following PDSAFE between 0 and 6 months among those with freezing of gait (interaction P=0.025), and a trend of increasing falls with those with cognitive impairment (interaction P=0.088).

Conclusions: No significant difference in the overall fall rate was found as a result of the intervention. Secondary analysis demonstrated improvements in fall risks such as balance and diverse responses in falls rate according to disease severity, freezing and cognitive deficits illustrating the heterogeneity of the sample. Future research should target specified groups.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/the-pdsafe-falls-prevention-programe-for-people-with-parkinsons-a-multicentre-randomised-controlled-trial/