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Randomised controlled trial (RCT) study design for a large-scale municipal fall prevention exercise programme in community-living older women: study protocol for the Kuopio Fall Prevention Study (KFPS).

ABSTRACT: INTRODUCTION:Falls are a substantial health problem in seniors, causing fractures and being the leading cause of fatal injuries. The benefits of physical activity in fall prevention have been shown in randomised controlled trials (RCTs) in small cohorts (eg, ?200 persons), but there is a gap between the known health effects of exercise and the large-scale implementation of effective activity in communities. Mental health and subjective well-being (SWB) should also be studied since they are strongly related to healthy ageing. Thus far, the proven efficacy of communal strategies to reduce falls and improve healthy ageing is sparse. METHODS AND ANALYSIS:In 2016, a 2-year RCT was launched in Kuopio, Finland to estimate the efficacy of a large, population-based, fall prevention exercise programme in community-living older women (born 1932-1945). Both the intervention and control group (n=457+457) receive health education. The intervention group is also offered free 6-month supervised training courses (weekly gym training and Taiji sessions), followed by a free 6-month unsupervised use of exercise facilities, as well as unsupervised low-cost exercise is also offered for another 12 months. During the whole 24-month follow-up, controls are free to pursue all their normal physical activities. Both study groups undergo the study measurements three times. Outcome measures include recording of falls, injuries, bone mineral density, changes in health and functional status and cognitive performance, deaths and SWB. Finally, the cost-effectiveness and cost-utility analysis will be conducted from the societal view. The main analyses comparing outcomes between study groups will be conducted using the intention to treat principle. ETHICS AND DISSEMINATION:The study has been reviewed and approved by the Research Ethics Committee of the Hospital District of North Savo. All regulations and measures of ethics and confidentiality are handled in accordance with the Declaration of Helsinki. TRIAL REGISTRATION NUMBER:NCT02665169; Pre-results.

SUBMITTER: Vilpunaho T

PROVIDER: S-EPMC6596943 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

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Randomised controlled trial (RCT) study design for a large-scale municipal fall prevention exercise programme in community-living older women: study protocol for the Kuopio Fall Prevention Study (KFPS).

Vilpunaho Tommi T Kröger Heikki H Honkanen Risto R Koivumaa-Honkanen Heli H Sirola Joonas J Kuvaja-Köllner Virpi V Sund Reijo R Rikkonen Toni T

BMJ open 20190621 6

<h4>Introduction</h4>Falls are a substantial health problem in seniors, causing fractures and being the leading cause of fatal injuries. The benefits of physical activity in fall prevention have been shown in randomised controlled trials (RCTs) in small cohorts (eg, ≤200 persons), but there is a gap between the known health effects of exercise and the large-scale implementation of effective activity in communities. Mental health and subjective well-being (SWB) should also be studied since they a ...[more]

PMID: 31230026

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Project description:IntroductionFalling in older age is a serious and costly problem. At least one in three older people fall annually. Although exercise is recognised as an effective fall prevention intervention, low numbers of older people engage in suitable programmes. Health and exercise professionals play a crucial role in addressing fall risk in older adults. This trial aims to evaluate the effect of participation in a fall prevention educational programme, compared with a wait-list control group, on health and exercise professionals' knowledge about fall prevention and the effect on fall prevention exercise prescription behaviour and confidence to prescribe the exercises to older people.Methods and analysisA randomised controlled trial involving 220 consenting health and exercise professionals will be conducted. Participants will be individually randomised to an intervention group (n=110) to receive an educational workshop plus access to internet-based support resources, or a wait-list control group (n=110). The two primary outcomes, measured 3 months after randomisation, are: (1) knowledge about fall prevention and (2) self-perceived change in fall prevention exercise prescription behaviour. Secondary outcomes include: (1) participants' confidence to prescribe fall prevention exercises; (2) the proportion of people aged 60+ years seen by trial participants in the past month who were prescribed fall prevention exercise; and (3) the proportion of fall prevention exercises prescribed by participants to older people in the past month that comply with evidence-based guidelines. Outcomes will be measured with a self-report questionnaire designed specifically for the trial.Ethics and disseminationThe trial protocol was approved by the Human Research Ethics Committee, The University of Sydney, Australia. Trial results will be disseminated via peer reviewed journals, presentations at international conferences and participants' newsletters.Trial registration numberTrial protocol was registered with the Australian and New Zealand Clinical Trials Registry (Number ACTRN12614000224628) on 3 March 2014.

Project description:ObjectiveOlder adults with vision impairment currently have no access to tailored fall prevention programmes. Therefore, the purpose of this study, nested within an ongoing randomised controlled trial (RCT), is to document the adaptation of an existing fall prevention programme and investigate the perspectives of instructors involved in delivery and the older adults with vision impairment receiving the programme (recipients).DesignWe documented programme adaptations and training requirements, and conducted semistructured, individual interviews with both the instructors and the recipients of the programme from 2017 to 2019. The content of each interview was analysed using behaviour change theory through deductive qualitative analysis.SettingNew South Wales and Australian Capital Territory, Australia.ParticipantsThe 11 trained instructors interviewed were employees of a vision rehabilitation organisation and had delivered at least one programme session as part of the RCT. The 154 recipients interviewed were community-dwelling adults aged ≥50 years with vision impairment and no diagnosis of dementia, and had completed their participation in the programme as part of the intervention group of the RCT.ResultsSix key themes were identified relating to recipient (delivery aptitude, social norms, habit formation) and instructor (individualised adaptation, complimentary to scope of practice, challenges to delivery) perspectives. With initial training, instructors required minimal ongoing support to deliver the programme and made dynamic adaptations to suit the individual circumstances of each recipient, but cited challenges delivering the number of programme activities required. Recipient perspectives varied; however, most appreciated the delivery of the programme by instructors who understood the impact of vision impairment.Conclusions and implicationsThis novel qualitative study demonstrates that the adapted programme, delivered by instructors, who already have expertise delivering individualised programmes to older people with vision impairment, may fill the gap for a fall prevention programme in this population.Trial registration numberACTRN12616001186448.

Project description:ObjectiveTo assess the effectiveness of a two year exercise programme of progressive balance retraining in reducing injurious falls among women aged 75-85 at increased risk of falls and injuries and living in the community.DesignPragmatic multicentre, two arm, parallel group, randomised controlled trial.Setting20 study sites in 16 medium to large cities throughout France.Participants706 women aged 75-85, living in their own home, and with diminished balance and gait capacities, randomly allocated to the experimental intervention group (exercise programme, n=352) or the control group (no intervention, n=354).InterventionWeekly supervised group sessions of progressive balance training offered in community based premises for two years, supplemented by individually prescribed home exercises.Outcome measuresA geriatrician blinded to group assignment classified falls into one of three categories (no consequence, moderate, severe) based on physical damage and medical care. The primary outcome was the rate of injurious falls (moderate and severe). The two groups were compared for rates of injurious falls with a "shared frailty" model. Other outcomes included the rates of all falls, physical functional capacities (balance and motor function test results), fear of falling (FES-I), physical activity level, and perceived health related quality of life (SF-36). Analysis was by intention to treat.ResultsThere were 305 injurious falls in the intervention group and 397 in the control group (hazard ratio 0.81, 95% confidence interval 0.67 to 0.99). The difference in severe injuries (68 in intervention group v 87 in control group) was of the same order of magnitude (0.83, 0.60 to 1.16). At two years, women in the intervention group performed significantly better on all physical tests and had significantly better perception of their overall physical function than women in the control group. Among women who started the intervention (n=294), the median number of group sessions attended was 53 (interquartile range 16-71). Five injurious falls related to the intervention were recorded.ConclusionA two year progressive balance retraining programme combining weekly group and individual sessions was effective in reducing injurious falls and in improving measured and perceived physical function in women aged 75-85 at risk of falling.Trial registration ClinicalTrials.gov (NCT00545350).

Project description:ObjectiveTo determine whether, and to what extent, fall prevention exercise interventions for older community dwelling people are effective in preventing different types of fall related injuries.Data sourcesElectronic databases (PubMed, the Cochrane Library, Embase, and CINAHL) and reference lists of included studies and relevant reviews from inception to July 2013.Study selectionRandomised controlled trials of fall prevention exercise interventions, targeting older (>60 years) community dwelling people and providing quantitative data on injurious falls, serious falls, or fall related fractures.Data synthesisBased on a systematic review of the case definitions used in the selected studies, we grouped the definitions of injurious falls into more homogeneous categories to allow comparisons of results across studies and the pooling of data. For each study we extracted or calculated the rate ratio of injurious falls. Depending on the available data, a given study could contribute data relevant to one or more categories of injurious falls. A pooled rate ratio was estimated for each category of injurious falls based on random effects models.Results17 trials involving 4305 participants were eligible for meta-analysis. Four categories of falls were identified: all injurious falls, falls resulting in medical care, severe injurious falls, and falls resulting in fractures. Exercise had a significant effect in all categories, with pooled estimates of the rate ratios of 0.63 (95% confidence interval 0.51 to 0.77, 10 trials) for all injurious falls, 0.70 (0.54 to 0.92, 8 trials) for falls resulting in medical care, 0.57 (0.36 to 0.90, 7 trials) for severe injurious falls, and 0.39 (0.22 to 0.66, 6 trials) for falls resulting in fractures, but significant heterogeneity was observed between studies of all injurious falls (I(2)=50%, P=0.04).ConclusionsExercise programmes designed to prevent falls in older adults also seem to prevent injuries caused by falls, including the most severe ones. Such programmes also reduce the rate of falls leading to medical care.

Project description:ObjectiveTo test whether StandingTall, a home based, e-health balance exercise programme delivered through an app, could provide an effective, self-managed fall prevention programme for community dwelling older people.DesignAssessor blinded, randomised controlled trial.SettingOlder people living independently in the community in Sydney, Australia.Participants503 people aged 70 years and older who were independent in activities of daily living, without cognitive impairment, progressive neurological disease, or any other unstable or acute medical condition precluding exercise.InterventionsParticipants were block randomised to an intervention group (two hours of StandingTall per week and health education; n=254) or a control group (health education; n=249) for two years.Main outcome measuresThe primary outcomes were the rate of falls (number of falls per person year) and the proportion of people who had a fall over 12 months. Secondary outcomes were the number of people who had a fall and the number who had an injurious fall (resulting in any injury or requiring medical care), adherence, mood, health related quality of life, and activity levels over 24 months; and balance and mobility outcomes over 12 months.ResultsThe fall rates were not statistically different in the two groups after the first 12 months (0.60 falls per year (standard deviation 1.05) in the intervention group; 0.76 (1.25) in the control group; incidence rate ratio 0.84, 95% confidence interval 0.62 to 1.13, P=0.071). Additionally, the proportion of people who fell was not statistically different at 12 months (34.6% in intervention group, 40.2% in control group; relative risk 0.90, 95% confidence interval 0.67 to 1.20, P=0.461). However, the intervention group had a 16% lower rate of falls over 24 months compared with the control group (incidence rate ratio 0.84, 95% confidence interval 0.72 to 0.98, P=0.027). Both groups had a similar proportion of people who fell over 24 months (relative risk 0.87, 95% confidence interval 0.68 to 1.10, P=0.239), but the proportion of people who had an injurious fall over 24 months was 20% lower in the intervention group compared with the control group (relative risk 0.80, 95% confidence interval 0.66 to 0.98, P=0.031). In the intervention group, 68.1% and 52.0% of participants exercised for a median of 114.0 min/week (interquartile range 53.5) after 12 months and 120.4 min/week (38.6) after 24 months, respectively. Groups remained similar in mood and activity levels. The intervention group had a 0.03 (95% confidence interval 0.01 to 0.06) improvement on the EQ-5D-5L (EuroQol five dimension five level) utility score at six months, and an improvement in standing balance of 11 s (95% confidence interval 2 to 19 s) at six months and 10 s (1 to 19 s) at 12 months. No serious training related adverse events occurred.ConclusionsThe StandingTall balance exercise programme did not significantly affect the primary outcomes of this study. However, the programme significantly reduced the rate of falls and the number of injurious falls over two years, with similar but not statistically significant effects at 12 months. E-health exercise programmes could provide promising scalable fall prevention strategies.Trial registrationACTRN12615000138583.

Dataset Information

Randomised controlled trial (RCT) study design for a large-scale municipal fall prevention exercise programme in community-living older women: study protocol for the Kuopio Fall Prevention Study (KFPS).

Publications

Randomised controlled trial (RCT) study design for a large-scale municipal fall prevention exercise programme in community-living older women: study protocol for the Kuopio Fall Prevention Study (KFPS).

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