Exercise- and strategy-based physiotherapy-delivered intervention for preventing repeat falls in people with Parkinson's:: the PDSAFE RCT

Background: People with Parkinson’s disease are twice as likely to experience a fall as a healthy older person, often leading to debilitating effects on confidence, activity levels and quality of life. Objective: To estimate the effect of a physiotherapy programme for fall prevention among people with Parkinson’s disease. Design: A multicentre, pragmatic, investigator-masked, individually randomised controlled trial (RCT) with prespecified subgroup analyses. Setting: Recruitment from NHS hospitals and clinics and community and social services in eight English regions with home-based interventions. Participants: A total of 474 people with Parkinson’s disease (i.e. Hoehn and Yahr scale stages 1–4) were recruited: 238 were assigned to a physiotherapy programme and 236 were assigned to usual care. Random allocation was 50: 50. Interventions: All participants received routine care; the usual-care group received an information digital versatile disc (DVD) and a single advice session at trial completion. The intervention group had an individually tailored, progressive, home-based fall avoidance strategy training programme with balance and strengthening exercises: PDSAFE. Main outcome measures: The primary outcome was the risk of repeat falling, collected by self-report monthly diaries between 0 and 6 months after randomisation. Secondary outcomes included near-falls, falls efficacy, freezing of gait (FoG), health-related quality of life, and measurements taken using the Mini-Balance Evaluation Systems Test (Mini-BESTest), the Chair Stand Test (CST), the Geriatric Depression Scale, the Physical Activity Scale for the Elderly and the Parkinson’s Disease Questionnaire. Results: PDSAFE is the largest RCT of falls management among people with Parkinson’s disease: 541 patients were screened for eligibility. The average age was 72 years, and 266 out of 474 (56%) participants were men. Of the 474 randomised participants, 238 were randomised to the intervention group and 236 were randomised to the control group. No difference in repeat falling within 6 months of randomisation was found [PDSAFE group to control group odds ratio (OR) 1.21, 95% confidence interval (CI) 0.74 to 1.98; p = 0.447]. An analysis of secondary outcomes demonstrated better balance (Mini-BESTest: mean difference 0.95, 95% CI 0.24 to 1.67; p = 0.009), functional strength (CST: p = 0.041) and falls efficacy (Falls Efficacy Scale – International: mean difference 1.6, 95% CI –3.0 to –0.19; p = 0.026) with near-falling significantly reduced with PDSAFE (OR 0.67, 95% CI 0.53 to 0.86; p = 0.001) at 6 months. Prespecified subgroup analysis (i.e. disease severity and FoG) revealed a PDSAFE differing effect; the intervention may be of benefit for people with moderate disease but may increase falling for those in the more severe category, especially those with FoG. Limitations: All participants were assessed at primary outcome; only 73% were assessed at 12 months owing to restricted funding. Conclusions: PDSAFE was not effective in reducing repeat falling across the range of people with Parkinson’s disease in the trial. Secondary analysis demonstrated that other functional tasks and self-efficacy improved and demonstrated differential patterns of intervention impact in accordance with disease severity and FoG, which supports previous secondary research findings and merits further primary evaluation. Future work: Further trials of falls prevention on targeted groups of people with Parkinson’s disease are recommended. Trial registration: Current Controlled Trials ISRCTN48152791.