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Objective: To investigate the effects of Pilates on falls risk, fear of falling, postural balance, functional mobility, spatiotemporal gait parameters, mobility and physical activity in older adults., Design: Randomized Controlled Trial (RCT)., Methods: Sixty-one older adults, mean age 70.08 (SD = 5.51) were randomly allocated into a Pilates group (PG, n = 29) or control group (CG, n = 32). Intervention comprised a 12-week Pilates program, with exercises performed twice a week and supplementary exercises at home. The Montreal Cognitive Assessment (MOCA), was used to screen cognition., Primary Outcomes: Fear of falling, postural balance (force platform), gait velocity (electronic walkway)., Secondary Outcomes: Functional mobility, mobility, physical activity, and spatiotemporal parameters of gait. Statistical analysis was carried out using Generalized Estimating Equations (GEE). Covariates were adjusted., Results: Positive effects were found for time effects: Time Up and Go (TUG), anteroposterior (AP) and mediolateral (ML) directions of balance, cadence, (stance, step and double support time). The step and double support time showed significant differences between the two groups (p < 0.05). Interaction between time and groups was found for FRT. Age was a significant factor in TUG, FRT, postural balance for AP under open eyes conditions. Health status was significant for ML in eyes open condition. Gait was significant for age, height and health status., Conclusion: Effects of 12 weeks of Pilates intervention on functional mobility, mobility, postural balance and spatiotemporal gait parameters were identified. Further trials of a longer duration are warranted to determine the effectiveness of Pilates on falls prevention., Competing Interests: Declarations of competing interest None'., (Copyright © 2022 Elsevier Ltd. All rights reserved.)

Objective: To determine the effectiveness of Pilates exercises on falls risk factors., Design: Prospective cohort, pre-test post-test study. Participants were selected using convenience and snowballing sampling. Pilates classes were held twice weekly for six weeks (1-h sessions) with a supplementary home programme., Methods: A test of cognitive function, the Montreal Cognitive Assessment (MOCA), was employed to determine eligibility for inclusion. The following fall-predictor variable measures were employed: the 16 item Falls Efficacy Scale (FES), the short International Physical Activity Questionnaire (IPAQ), the Functional Reach Test (FRT), the Timed Up and Go (TUG), the GAITRite® system, Platform FOOTWORKpro. Multivariate analysis ANOVA with time as within subject factor was used to test for differences between pre and post-test scores adjusted for the factor Pilates., Results: twenty-seven participants completed the study, mean age = 70.4 (SD = 4.5). After adjusting for the effect of the factor Pilates "previous experience or no previous experience of Pilates", statistically significant differences were identified in the following domains: The TUG (p < 0.001), FRT (p < 0.001), velocity, swing and stance time and the Mediolateral sway (p < 0.05). A significant difference was found between pre and post-test for anteroposterior sway in those with experience of Pilates (p < 0.05) and interaction between time and Pilates experience in Physical Activity (p < 0.05)., Conclusion: Findings suggest that functional mobility, mobility, spatiotemporal parameters of gait, postural balance and physical activity improved in healthy older adults after 6 weeks of Pilates with a supplementary home programme., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

Background: Falls are a serious cause of morbidity and cost to individuals and society. Evidence suggests that foot problems and inappropriate footwear may increase the risk of falling. Podiatric interventions could help reduce falls; however, there is limited evidence regarding their clinical effectiveness and cost-effectiveness., Objectives: To determine the clinical effectiveness and cost-effectiveness of a multifaceted podiatry intervention for preventing falls in community-dwelling older people at risk of falling, relative to usual care., Design: A pragmatic, multicentred, cohort randomised controlled trial with an economic evaluation and qualitative study., Setting: Nine NHS trusts in the UK and one site in Ireland., Participants: In total, 1010 participants aged ≥ 65 years were randomised (intervention, n  = 493; usual care, n  = 517) via a secure, remote service. Blinding was not possible., Interventions: All participants received a falls prevention leaflet and routine care from their podiatrist and general practitioner. The intervention also consisted of footwear advice, footwear provision if required, foot orthoses and foot- and ankle-strengthening exercises., Main Outcome Measures: The primary outcome was the incidence rate of falls per participant in the 12 months following randomisation. The secondary outcomes included the proportion of fallers and multiple fallers, time to first fall, fear of falling, fracture rate, health-related quality of life (HRQoL) and cost-effectiveness., Results: The primary analysis consisted of 484 (98.2%) intervention and 507 (98.1%) usual-care participants. There was a non-statistically significant reduction in the incidence rate of falls in the intervention group [adjusted incidence rate ratio 0.88, 95% confidence interval (CI) 0.73 to 1.05; p  = 0.16]. The proportion of participants experiencing a fall was lower (50% vs. 55%, adjusted odds ratio 0.78, 95% CI 0.60 to 1.00; p  = 0.05). No differences were observed in key secondary outcomes. No serious, unexpected and related adverse events were reported. The intervention costs £252.17 more per participant (95% CI -£69.48 to £589.38) than usual care, was marginally more beneficial in terms of HRQoL measured via the EuroQoL-5 Dimensions [mean quality-adjusted life-year (QALY) difference 0.0129, 95% CI -0.0050 to 0.0314 QALYs] and had a 65% probability of being cost-effective at the National Institute for Health and Care Excellence threshold of £30,000 per QALY gained. The intervention was generally acceptable to podiatrists and trial participants., Limitations: Owing to the difficulty in calculating a sample size for a count outcome, the sample size was based on detecting a difference in the proportion of participants experiencing at least one fall, and not the primary outcome. We are therefore unable to confirm if the trial was sufficiently powered for the primary outcome. The findings are not generalisable to patients who are not receiving podiatry care., Conclusions: The intervention was safe and potentially effective. Although the primary outcome measure did not reach significance, a lower fall rate was observed in the intervention group. The reduction in the proportion of older adults who experienced a fall was of borderline statistical significance. The economic evaluation suggests that the intervention could be cost-effective., Future Work: Further research could examine whether or not the intervention could be delivered in group sessions, by physiotherapists, or in high-risk patients., Trial Registration: Current Controlled Trials ISRCTN68240461., 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. 21, No. 24. See the NIHR Journals Library website for further project information.

Background: Randomised controlled trials are generally regarded as the 'gold standard' experimental design to determine the effectiveness of an intervention. Unfortunately, many trials either fail to recruit sufficient numbers of participants, or recruitment takes longer than anticipated. The current embedded trial evaluates the effectiveness of optimised patient information sheets on recruitment of participants in a falls prevention trial., Methods: A three-arm, embedded randomised methodology trial was conducted within the National Institute for Health Research-funded REducing Falls with ORthoses and a Multifaceted podiatry intervention (REFORM) cohort randomised controlled trial. Routine National Health Service podiatry patients over the age of 65 were randomised to receive either the control patient information sheet (PIS) for the host trial or one of two optimised versions, a bespoke user-tested PIS or a template-developed PIS. The primary outcome was the proportion of patients in each group who went on to be randomised to the host trial., Results: Six thousand and nine hundred patients were randomised 1:1:1 into the embedded trial. A total of 193 (2.8%) went on to be randomised into the main REFORM trial (control n = 62, template-developed n = 68; bespoke user-tested n = 63). Information sheet allocation did not improve recruitment to the trial (odds ratios for the three pairwise comparisons: template vs control 1.10 (95% CI 0.77-1.56, p = 0.60); user-tested vs control 1.01 (95% CI 0.71-1.45, p = 0.94); and user-tested vs template 0.92 (95% CI 0.65-1.31, p = 0.65))., Conclusions: This embedded methodology trial has demonstrated limited evidence as to the benefit of using optimised information materials on recruitment and retention rates in the REFORM study., Trial Registration: International Standard Randomised Controlled Trials Number registry, ISRCTN68240461 . Registered on 01 July 2011.

Background: Falls are a major cause of morbidity among older people. A multifaceted podiatry intervention may reduce the risk of falling. This study evaluated such an intervention., Design: Pragmatic cohort randomised controlled trial in England and Ireland. 1010 participants were randomised (493 to the Intervention group and 517 to Usual Care) to either: a podiatry intervention, including foot and ankle exercises, foot orthoses and, if required, new footwear, and a falls prevention leaflet or usual podiatry treatment plus a falls prevention leaflet. The primary outcome was the incidence rate of self-reported falls per participant in the 12 months following randomisation. Secondary outcomes included: proportion of fallers and those reporting multiple falls, time to first fall, fear of falling, Frenchay Activities Index, Geriatric Depression Scale, foot pain, health related quality of life, and cost-effectiveness., Results: In the primary analysis were 484 (98.2%) intervention and 507 (98.1%) control participants. There was a small, non statistically significant reduction in the incidence rate of falls in the intervention group (adjusted incidence rate ratio 0.88, 95% CI 0.73 to 1.05, p = 0.16). The proportion of participants experiencing a fall was lower (49.7 vs 54.9%, adjusted odds ratio 0.78, 95% CI 0.60 to 1.00, p = 0.05) as was the proportion experiencing two or more falls (27.6% vs 34.6%, adjusted odds ratio 0.69, 95% CI 0.52 to 0.90, p = 0.01). There was an increase (p = 0.02) in foot pain for the intervention group. There were no statistically significant differences in other outcomes. The intervention was more costly but marginally more beneficial in terms of health-related quality of life (mean quality adjusted life year (QALY) difference 0.0129, 95% CI -0.0050 to 0.0314) and had a 65% probability of being cost-effective at a threshold of £30,000 per QALY gained., Conclusion: There was a small reduction in falls. The intervention may be cost-effective., Trial Registration: ISRCTN ISRCTN68240461., Competing Interests: The authors have declared that no competing interests exist.

Introduction: Falls and fall-related injuries are a serious cause of morbidity and cost to society. Foot problems and inappropriate footwear may increase the risk of falls; therefore podiatric interventions may play a role in reducing falls. Two Cochrane systematic reviews identified only one study of a podiatry intervention aimed to reduce falls, which was undertaken in Australia. The REFORM trial aims to evaluate the clinical and cost-effectiveness of a multifaceted podiatry intervention in reducing falls in people aged 65 years and over in a UK and Irish setting., Methods and Analysis: This multicentre, cohort randomised controlled trial will recruit 2600 participants from routine podiatry clinics in the UK and Ireland to the REFORM cohort. In order to detect a 10% point reduction in falls from 50% to 40%, with 80% power 890 participants will be randomised to receive routine podiatry care and a falls prevention leaflet or routine podiatry care, a falls prevention leaflet and a multifaceted podiatry intervention. The primary outcome is rate of falls (falls/person/time) over 12 months assessed by patient self-report falls diary. Secondary self-report outcome measures include: the proportion of single and multiple fallers and time to first fall over a 12-month period; Short Falls Efficacy Scale-International; fear of falling in the past 4 weeks; Frenchay Activities Index; fracture rate; Geriatric Depression Scale; EuroQoL-five dimensional scale 3-L; health service utilisation at 6 and 12 months. A qualitative study will examine the acceptability of the package of care to participants and podiatrists., Ethics and Dissemination: The trial has received a favourable opinion from the East of England-Cambridge East Research Ethics Committee and Galway Research Ethics Committee. The trial results will be published in peer-reviewed journals and at conference presentations., Trial Registration Number: Current Controlled Trials ISRCTN68240461 assigned 01/07/2011., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)