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Exercise- and strategy-based physiotherapy-delivered intervention for preventing repeat falls in people with Parkinson's: the PDSAFE RCT.
Health Technol Assess. 2019 07; 23(36):1-150.HT

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.

Authors+Show Affiliations

Faculty of Health Science, University of Southampton, Southampton, UK.Faculty of Medicine, University of Southampton, Southampton, UK.Health Economics and Health Technology Assessment, Institute of Health & Wellbeing, University of Glasgow, Glasgow, UK.Faculty of Health Science, University of Southampton, Southampton, UK.Institute of Neuroscience, Newcastle University, Newcastle upon Tyne, UK.Faculty of Medicine, University of Southampton, Southampton, UK.Department of Rehabilitation Sciences, Katholieke Universiteit Leuven, Leuven, Belgium.Faculty of Health Science, University of Southampton, Southampton, UK.Medical School, University of Exeter, Exeter, UK.Oxford Clinical Trials Research Unit, University of Oxford Medical Sciences Division, Oxford, UK.Wessex Public Involvement Network (PIN), University of Southampton, Southampton General Hospital, Southampton, UK.Faculty of Health Science, University of Southampton, Southampton, UK.

Pub Type(s)

Journal Article
Multicenter Study
Pragmatic Clinical Trial
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

31339100

Citation

Ashburn, Ann, et al. "Exercise- and Strategy-based Physiotherapy-delivered Intervention for Preventing Repeat Falls in People With Parkinson's: the PDSAFE RCT." Health Technology Assessment (Winchester, England), vol. 23, no. 36, 2019, pp. 1-150.
Ashburn A, Pickering R, McIntosh E, et al. Exercise- and strategy-based physiotherapy-delivered intervention for preventing repeat falls in people with Parkinson's: the PDSAFE RCT. Health Technol Assess. 2019;23(36):1-150.
Ashburn, A., Pickering, R., McIntosh, E., Hulbert, S., Rochester, L., Roberts, H. C., Nieuwboer, A., Kunkel, D., Goodwin, V. A., Lamb, S. E., Ballinger, C., & Seymour, K. C. (2019). Exercise- and strategy-based physiotherapy-delivered intervention for preventing repeat falls in people with Parkinson's: the PDSAFE RCT. Health Technology Assessment (Winchester, England), 23(36), 1-150. https://doi.org/10.3310/hta23360
Ashburn A, et al. Exercise- and Strategy-based Physiotherapy-delivered Intervention for Preventing Repeat Falls in People With Parkinson's: the PDSAFE RCT. Health Technol Assess. 2019;23(36):1-150. PubMed PMID: 31339100.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Exercise- and strategy-based physiotherapy-delivered intervention for preventing repeat falls in people with Parkinson's: the PDSAFE RCT. AU - Ashburn,Ann, AU - Pickering,Ruth, AU - McIntosh,Emma, AU - Hulbert,Sophia, AU - Rochester,Lynn, AU - Roberts,Helen C, AU - Nieuwboer,Alice, AU - Kunkel,Dorit, AU - Goodwin,Victoria A, AU - Lamb,Sarah E, AU - Ballinger,Claire, AU - Seymour,Kim Chivers, PY - 2019/7/25/entrez PY - 2019/7/25/pubmed PY - 2020/10/2/medline KW - COGNITION KW - COGNITIVE DYSFUNCTION KW - COST–UTILITY ANALYSIS KW - EXERCISE KW - EXERCISE THERAPY KW - FREEZING OF GAIT KW - GAIT KW - OUTCOME ASSESSMENT (HEALTH CARE) KW - PARKINSONIAN DISORDERS KW - PARKINSON’S KW - PHYSICAL THERAPISTS KW - QUALITY OF LIFE KW - SURVEYS AND QUESTIONNAIRES KW - TECHNOLOGY ASSESSMENT, BIOMEDICAL SP - 1 EP - 150 JF - Health technology assessment (Winchester, England) JO - Health Technol Assess VL - 23 IS - 36 N2 - 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. SN - 2046-4924 UR - https://www.unboundmedicine.com/medline/citation/31339100/Exercise__and_strategy_based_physiotherapy_delivered_intervention_for_preventing_repeat_falls_in_people_with_Parkinson's:_the_PDSAFE_RCT_ L2 - https://doi.org/10.3310/hta23360 DB - PRIME DP - Unbound Medicine ER -