Objectives To compare the effectiveness of an exercise programme with usual care in people with Parkinson's disease (PD) who have a history of falls.
Design Pragmatic randomised controlled trial.
Setting Recruitment was from three primary and four secondary care organisations, and PD support groups in South West England. The intervention was delivered in community settings.
Participants People with PD, with a history of two or more falls in the previous year, who were able to mobilise independently.
Intervention 10 week, physiotherapy led, group delivered strength and balance training programme with supplementary home exercises (intervention) or usual care (control).
Main outcome measure Number of falls during the (a) 10 week intervention period and (b) the 10 week follow-up period.
Results 130 people were recruited and randomised (64 to the intervention; 66 to usual care). Seven participants (5.4%) did not complete the study. The incidence rate ratio for falls was 0.68 (95% CI 0.43 to 1.07, p=0.10) during the intervention period and 0.74 (95% CI 0.41 to 1.33, p=0.31) during the follow-up period. Statistically significant between group differences were observed in Berg balance, Falls Efficacy Scale-International scores and recreational physical activity levels.
Conclusions The study did not demonstrate a statistically significant between group difference in falls although the difference could be considered clinically significant. However, a type 2 error cannot be ruled out. The findings from this trial add to the evidence base for physiotherapy and exercise in the management of people with PD.
Trial registration ISRCTN50793425.
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Funding VG was funded to undertake this research as part of an NIHR Researcher Development Award (grant No RDA/02/06/41). This article presents independent research commissioned by the National Institute for Health Research (NIHR). The views expressed in this publication are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health.
Competing interests PCMD (VG, WH) and University of Exeter (AT) received funding from NIHR to undertake this research.
Ethics approval Ethics approval was provided by Devon and Torbay Local Research Ethics Committee.
Provenance and peer review Not commissioned; externally peer reviewed.
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