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.
Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 36. See the NIHR Journals Library website for further project information. Sarah E Lamb is funded by the NIHR Collaboration for Leadership in Applied Health Research and Care (CLAHRC) at Oxford Health NHS Foundation Trust, the NIHR Oxford Biomedical Research Centre at the Oxford University Hospitals NHS Foundation Trust and CLAHRC Oxford. Victoria A Goodwin is supported by the NIHR Collaborations for Leadership in Applied Health Research and Care in the South West Peninsula (PenCLAHRC). Lynn Rochester is supported by the NIHR Newcastle Biomedical Research Centre based at Newcastle upon Tyne Hospitals NHS Foundation Trust and Newcastle University. The research was also supported by the NIHR Newcastle Clinical Research Facility Infrastructure funding. Helen C Roberts is supported by CLAHRC Wessex and the NIHR Southampton Biomedical Research Centre.
Keywords: COGNITION; COGNITIVE DYSFUNCTION; COST–UTILITY ANALYSIS; EXERCISE; EXERCISE THERAPY; FREEZING OF GAIT; GAIT; OUTCOME ASSESSMENT (HEALTH CARE); PARKINSONIAN DISORDERS; PARKINSON’S; PHYSICAL THERAPISTS; QUALITY OF LIFE; SURVEYS AND QUESTIONNAIRES; TECHNOLOGY ASSESSMENT, BIOMEDICAL.
People with Parkinson’s disease fall often. Falls are scary and make moving about harder. The PDSAFE trial tested a new ‘home physiotherapy’ programme for reducing falls. People with Parkinson’s disease were allocated to one of two groups by chance: they either received the PDSAFE exercises or just normal care. The costs were looked at and people were asked for their views of the PDSAFE exercises. To take part, people had to have Parkinson’s disease, live in their own home, be able to walk, have had at least one fall in the previous year and pass a memory test. PDSAFE was taught by physiotherapists and included exercises and fall avoidance strategies. Everyone had to record falls on a monthly calendar, and balance, strength and walking were tested. To our knowledge, this was the largest falls trial looking at people with Parkinson’s disease in the world: 541 people took part. The number of falls an individual reported differed a lot between people. When all people with Parkinson’s disease in the trial were considered, the physiotherapy programme did not reduce falls in the first 6 months. However, it was found that some people had fewer falls after taking part in the exercises, whereas others did not. Those with more severe Parkinson’s disease (i.e. problems with movement, memory and freezing of gait) fell more often after the PDSAFE intervention, even though their balance and confidence improved. Those with good memory, moderate disease and two or three falls in the previous year reacted well to PDSAFE and had fewer falls. It was found that PDSAFE reduced near-falls (about to fall but managed to save themselves) and improved balance and confidence. The physiotherapists and those who took part liked the programme and felt that it helped, but it was expensive to run. In conclusion, a falls prevention programme should be based on each person’s needs and a different treatment should be used for those with more severe Parkinson’s disease.