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

Abstract

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.

Current Perspectives on Aerobic Exercise in People with Parkinson's Disease

“…Barriers include a range of factors like low self-efficacy, generic health issues, poor access to the exercise location, mobility problems such as postural instability, and non-motor symptoms such as fatigue and depression [57][58][59][60][61][62][63][65][66][67][68][69][70][71]. On the other hand, social support by family, friends, or a professional and education about the benefits of exercise can motivate PD patients to become more physically active [57,59,60,[62][63][64][65][66][67][68][69][72][73][74]. At least 150 min of moderate-intensity exercise spread over multiple days is advised [5], but we find it helpful to instruct patients to exercise on a daily basis so it becomes part of their everyday routine.…”

Barriers and Motivators to Engage in Exercise for Persons with Parkinson’s Disease

“…Our review also emphasizes that non-motor symptoms can create a barrier to engage in exercise [12,[15][16][17][18][21][22][23][24][25]. For example, people might need to overcome negative thoughts (e.g., "exercise will make me feel more tired") when they start with exercise.…”

“…In order to motivate persons with PD to become and stay physically active beyond the setting of a clinical trial, it is pivotal to gain a better knowledge of the many barriers (but also the various motivators) for exercise. Previous exercise studies provided some insight into the barriers and motivators that persons with PD encounter, although one must consider the possibility of selection bias here, as exercise studies typically tend to recruit people who are already most motivated to increase their physical activities [10][11][12][13][14][15][16]. Here, we summarize the various barriers and motivators for exercise in persons with PD by applying a comprehensive review of the literature.…”

Efeito do treinamento multicomponente e mat pilates sobre variáveis cinemáticas da marcha de indivíduos com Doença de Parkinson em situação de bloqueio da visão dos pés: um ensaio clínico randomizado-controlado unicego

“…A doença de Parkinson (DP) é uma afecção neurológica progressiva caracterizada por déficits no movimento e equilíbrio, além de disfunções não motoras [1]. A DP é a segunda doença neurodegenerativa mais frequente e atinge 2-3% da população com idade igual ou superior a 65 anos [2].…”

“…Há evidências de que existe benefícios na associação do exercício físico ao tratamento médico sobre os sintomas da DP, o qual promove melhora do controle postural, aumento da força muscular, melhora do desempenho da marcha e mobilidade, além de manutenção na capacidade de execução das atividades de vida diária [1,9].…”