Resistance exercise as a treatment for sarcopenia: prescription and delivery.

Sarcopenia is a generalised skeletal muscle disorder characterised by reduced muscle strength and mass and associated with a range of negative health outcomes. Currently, resistance exercise (RE) is recommended as the first-line treatment for counteracting the deleterious consequences of sarcopenia in older adults. However, whilst there is considerable evidence demonstrating that RE is an effective intervention for improving muscle strength and function in healthy older adults, much less is known about its benefits in older people living with sarcopenia. Furthermore, evidence for its optimal prescription and delivery is very limited and any potential benefits of RE are unlikely to be realised in the absence of an appropriate exercise dose. We provide a summary of the underlying principles of effective RE prescription (specificity, overload and progression) and discuss the main variables (training frequency, exercise selection, exercise intensity, exercise volume and rest periods) that can be manipulated when designing RE programmes. Following this, we propose that an RE programme that consists of two exercise sessions per week and involves a combination of upper- and lower-body exercises performed with a relatively high degree of effort for 1-3 sets of 6-12 repetitions is appropriate as a treatment for sarcopenia. The principles of RE prescription outlined here and the proposed RE programme presented in this paper provide a useful resource for clinicians and exercise practitioners treating older adults with sarcopenia and will also be of value to researchers for standardising approaches to RE interventions in future sarcopenia studies.

Fall prevention interventions in primary care to reduce fractures and falls in people aged 70 years and over: the PreFIT three-arm cluster RCT.

BACKGROUND: Falls and fractures are a major problem. OBJECTIVES: To investigate the clinical effectiveness and cost-effectiveness of alternative falls prevention interventions. DESIGN: Three-arm, pragmatic, cluster randomised controlled trial with parallel economic analysis. The unit of randomisation was the general practice. SETTING: Primary care. PARTICIPANTS: People aged ≥ 70 years. INTERVENTIONS: All practices posted an advice leaflet to each participant. Practices randomised to active intervention arms (exercise and multifactorial falls prevention) screened participants for falls risk using a postal questionnaire. Active treatments were delivered to participants at higher risk of falling. MAIN OUTCOME MEASURES: The primary outcome was fracture rate over 18 months, captured from Hospital Episode Statistics, general practice records and self-report. Secondary outcomes were falls rate, health-related quality of life, mortality, frailty and health service resource use. Economic evaluation was expressed in terms of incremental cost per quality-adjusted life-year and incremental net monetary benefit. RESULTS: Between 2011 and 2014, we randomised 63 general practices (9803 participants): 21 practices (3223 participants) to advice only, 21 practices (3279 participants) to exercise and 21 practices (3301 participants) to multifactorial falls prevention. In the active intervention arms, 5779 out of 6580 (87.8%) participants responded to the postal fall risk screener, of whom 2153 (37.3%) were classed as being at higher risk of falling and invited for treatment. The rate of intervention uptake was 65% (697 out of 1079) in the exercise arm and 71% (762 out of 1074) in the multifactorial falls prevention arm. Overall, 379 out of 9803 (3.9%) participants sustained a fracture. There was no difference in the fracture rate between the advice and exercise arms (rate ratio 1.20, 95% confidence interval 0.91 to 1.59) or between the advice and multifactorial falls prevention arms (rate ratio 1.30, 95% confidence interval 0.99 to 1.71). There was no difference in falls rate over 18 months (exercise arm: rate ratio 0.99, 95% confidence interval 0.86 to 1.14; multifactorial falls prevention arm: rate ratio 1.13, 95% confidence interval 0.98 to 1.30). A lower rate of falls was observed in the exercise arm at 8 months (rate ratio 0.78, 95% confidence interval 0.64 to 0.96), but not at other time points. There were 289 (2.9%) deaths, with no differences by treatment arm. There was no evidence of effects in prespecified subgroup comparisons, nor in nested intention-to-treat analyses that considered only those at higher risk of falling. Exercise provided the highest expected quality-adjusted life-years (1.120), followed by advice and multifactorial falls prevention, with 1.106 and 1.114 quality-adjusted life-years, respectively. NHS costs associated with exercise (£3720) were lower than the costs of advice (£3737) or of multifactorial falls prevention (£3941). Although incremental differences between treatment arms were small, exercise dominated advice, which in turn dominated multifactorial falls prevention. The incremental net monetary benefit of exercise relative to treatment valued at £30,000 per quality-adjusted life-year is modest, at £191, and for multifactorial falls prevention is £613. Exercise is the most cost-effective treatment. No serious adverse events were reported. LIMITATIONS: The rate of fractures was lower than anticipated. CONCLUSIONS: Screen-and-treat falls prevention strategies in primary care did not reduce fractures. Exercise resulted in a short-term reduction in falls and was cost-effective. FUTURE WORK: Exercise is the most promising intervention for primary care. Work is needed to ensure adequate uptake and sustained effects. TRIAL REGISTRATION: Current Controlled Trials ISRCTN71002650. 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. 25, No. 34. See the NIHR Journals Library website for further project information.

WHAT IS THE PROBLEM?: Falls are a major problem for older people. Current practice is to give people advice leaflets. Another approach is exercise, especially balance and strength training. A third alternative is to invite older people to attend a falls assessment with a health-care professional, either a doctor or a trained nurse. This usually involves a careful check of prescribed tablets, blood pressure, eyesight and other problems that might cause falls. WHAT DID WE DO?: We compared three strategies. We recruited 9803 people aged 70­101 years from 63 general practices across England. We randomly allocated practices in clusters into three treatment groups. The participants in one group were given a Staying Steady advice leaflet (Age UK. Staying Steady. London: Age UK; 2009). Participants in the second group received the same leaflet and were assessed to see if they were at higher risk of falling. Those participants identified as being at higher risk (about 1000 people) were invited to take part in an exercise programme, supported by an exercise therapist. These people did balance and strength training at home for up to 6 months. In the third group, we again identified participants who were at higher risk of falling (about 1000 people) and invited them for a detailed falls assessment with a trained nurse or doctor. This last group of participants were referred for other treatments if any health problems were found. In all groups we counted fractures and falls and measured changes in quality of life, frailty and the cost of the treatments over 18 months of follow-up. WHAT DID WE FIND OUT?: We found no difference in the number of fractures over 18 months between the different treatments. The exercise programme reduced falls in the short term but not over the longer term. The exercise programme was cheaper and led to a slightly better overall quality of life.

Life after falls prevention exercise - experiences of older people taking part in a clinical trial: a phenomenological study.

BACKGROUND: There is little evidence about the lived experience of older people who have completed a falls prevention exercise programme and their life beyond their intervention. METHOD: A phenomenological interview study with 23 participants (12 females), mean age 81 years (range 74-93 years), residing in their own homes across England, who had participated in a falls prevention exercise intervention within the Prevention of Falls Injury Trial (PreFIT). The aims were to explore their experiences of: i. being in a clinical trial involving exercise. ii. exercise once their falls prevention intervention had finished. Interpretative data analysis was informed by van Manen's (1997) framework for phenomenological data. RESULTS: Analysis of interviews about experiences of participating in PreFIT and what happened once the falls intervention ended identified five themes: Happy to help; Exercise behaviours; "It keeps me going"; "It wasn't a real fall"; and Loss. Participants did not continue their specific exercises after they had completed the intervention. They preferred walking as their main exercise, and none reported preventing falls as a motivator to continue exercising. Participant experiences suggest that they have their own ideas about what constitutes a fall and there is disparity between their interpretation and the definition used by healthcare professionals and researchers. CONCLUSION: Despite good intentions and perceived benefits, on-going participation in falls prevention exercises beyond a structured, supervised intervention was not a priority for these older people. Promoting continuation of falls prevention exercises post-intervention is just as challenging as promoting uptake to and adherence during exercise programmes.

Screening and Intervention to Prevent Falls and Fractures in Older People.

BACKGROUND: Community screening and therapeutic prevention strategies may reduce the incidence of falls in older people. The effects of these measures on the incidence of fractures, the use of health resources, and health-related quality of life are unknown. METHODS: In a pragmatic, three-group, cluster-randomized, controlled trial, we estimated the effect of advice sent by mail, risk screening for falls, and targeted interventions (multifactorial fall prevention or exercise for people at increased risk for falls) as compared with advice by mail only. The primary outcome was the rate of fractures per 100 person-years over 18 months. Secondary outcomes were falls, health-related quality of life, frailty, and a parallel economic evaluation. RESULTS: We randomly selected 9803 persons 70 years of age or older from 63 general practices across England: 3223 were assigned to advice by mail alone, 3279 to falls-risk screening and targeted exercise in addition to advice by mail, and 3301 to falls-risk screening and targeted multifactorial fall prevention in addition to advice by mail. A falls-risk screening questionnaire was sent to persons assigned to the exercise and multifactorial fall-prevention groups. Completed screening questionnaires were returned by 2925 of the 3279 participants (89%) in the exercise group and by 2854 of the 3301 participants (87%) in the multifactorial fall-prevention group. Of the 5779 participants from both these groups who returned questionnaires, 2153 (37%) were considered to be at increased risk for falls and were invited to receive the intervention. Fracture data were available for 9802 of the 9803 participants. Screening and targeted intervention did not result in lower fracture rates; the rate ratio for fracture with exercise as compared with advice by mail was 1.20 (95% confidence interval [CI], 0.91 to 1.59), and the rate ratio with multifactorial fall prevention as compared with advice by mail was 1.30 (95% CI, 0.99 to 1.71). The exercise strategy was associated with small gains in health-related quality of life and the lowest overall costs. There were three adverse events (one episode of angina, one fall during a multifactorial fall-prevention assessment, and one hip fracture) during the trial period. CONCLUSIONS: Advice by mail, screening for fall risk, and a targeted exercise or multifactorial intervention to prevent falls did not result in fewer fractures than advice by mail alone. (Funded by the National Institute of Health Research; ISRCTN number, ISRCTN71002650.).

Moderators of Cognitive Outcomes from an Exercise Program in People with Mild to Moderate Dementia.

BACKGROUND/OBJECTIVES: Our aim was to estimate whether baseline participant variables were able to moderate the effect of an exercise intervention on cognition in patients with mild to moderate dementia. DESIGN: Subgroup analysis of a multicenter pragmatic randomized controlled trial. SETTING: Community-based gym/rehabilitation centers. PARTICIPANTS: A total of 494 community-dwelling participants with mild to moderate dementia. INTERVENTION: Participants were randomized to a moderate- to high-intensity aerobic and strength exercise program or a usual care control group. Experimental group participants attended twice weekly 60- to 90-minute gym sessions for 4 months. Participants were prescribed home exercises for an additional hour per week during the supervised period and 150 minutes each week after the supervised period. MEASUREMENTS: Multilevel regression model analyses were undertaken to identify individual moderators of cognitive function measured through the Alzheimer Disease Assessment Scale-Cognitive Subscale score at 12 months. RESULTS: When tested for a formal interaction effect, only cognitive function assessed by the baseline number cancellation test demonstrated a statistically significant interaction effect (-2.7 points; 95% confidence interval = -5.14 to -0.21). CONCLUSION: People with worse number cancellation test scores may experience greater progression of cognitive decline in response to a moderate- to high-intensity exercise program. Further analyses to examine whether these findings can be replicated in planned sufficiently powered analyses are indicated.

What enables older people to continue with their falls prevention exercises? A qualitative systematic review.

OBJECTIVES: To review the qualitative literature that explores the barriers and facilitators to continued participation in falls prevention exercise after completion of a structured exercise programme. DESIGN: A systematic literature review with thematic synthesis of qualitative studies exploring older adults' experiences of continued participation in falls prevention exercise. DATA SOURCES: Comprehensive searches were conducted in MEDLINE, PSYCHinfo, AMED, ASSIA, CINAHL and EMBASE from inception until November 2017. Additional studies were identified via searches of reference lists and citation tracking of relevant studies. ELIGIBILITY CRITERIA: Qualitative or mixed methods studies exploring experiences of community-dwelling older adults (65 years and over) participation in a falls prevention exercise programme including their experience of ongoing participation in exercise after the completion of a structured exercise programme. DATA EXTRACTION AND SYNTHESIS: Key characteristics including aim, participant characteristics, method of data collection, underpinning qualitative methodology and analytical approach were extracted and independently checked. Thematic synthesis was used to integrate findings. RESULTS: From 14 studies involving 425 participants, we identified three descriptive themes: identity, motivators/deterrents and nature of the intervention and one overarching analytical theme: agency. CONCLUSIONS: Older people have their own individual and meaningful rationale for either continuing or stopping exercise after completion of a structured falls prevention exercise programme. Exploring these barriers and facilitators to continued exercise is key during the intervention phase. It is important that health care professionals get to know the older person's rationale and offer the best evidence-based practice and support to individuals, to ensure a smooth transition from their structured intervention towards longer-term exercise-related behaviour. PROSPERO REGISTRATION NUMBER: CRD42017082637.

Long-term follow-up of exercise interventions aimed at preventing falls in older people living in the community: a systematic review and meta-analysis.

BACKGROUND: Fall-related injuries are the leading cause of accident-related mortality for older adults, with 30% of those aged 65 years and over falling annually. Exercise is effective in reducing rate and risk of falls in community-dwelling adults; however, there is lack of evidence for the long-term effects of exercise. OBJECTIVES: To assess the long-term effect of exercise interventions on preventing falls in community-dwelling older adults. DATA SOURCES: Searches were undertaken on MEDLINE, EMBASE, AMED, CINAHL, psycINFO, the Physiotherapy Evidence Database (PEDro) and The Cochrane Library from inception to April 2017. STUDY SELECTION: Randomised controlled trials (RCTs), cohort studies or secondary analyses of RCTs with long-term follow-up (>12months) of exercise interventions involving community-dwelling older adults (65 and over) compared to a control group. DATA EXTRACTION/ DATA SYNTHESIS: Pairs of review authors independently extracted data. Review Manager (RevMan 5.1) was used for meta-analysis and data were extracted using rate ratio (RaR) and risk ratio (RR). RESULTS: Twenty-four studies (7818 participants) were included. The overall pooled estimate of the effect of exercise on rate of falling beyond 12-month follow-up was rate ratio (RaR) 0.79 (95% confidence interval (CI) 0.71 to 0.88) and risk of falling was risk ratio (RR) 0.83 (95% CI 0.76 to 0.92) Subgroup analyses revealed that there was no sustained effect on rate or risk of falling beyond two years post intervention. CONCLUSIONS: Falls prevention exercise programmes have sustained long-term effects on the number of people falling and the number of falls for up to two years after an exercise intervention. SYSTEMATIC REVIEW REGISTRATION NUMBER: CRD42017062461.

Comparison of alternative falls data collection methods in the Prevention of Falls Injury Trial (PreFIT).

BACKGROUND AND OBJECTIVES: Prospective, monthly diaries are recommended for collecting falls data but are burdensome and expensive. The aim of the article was to compare characteristics of fallers and estimates of fall rates by method of data collection. STUDY DESIGN AND SETTING: A methodology study nested within a large cluster randomized controlled trial. We randomized 9,803 older adults from 63 general practices across England to receive one of three fall prevention interventions. Participants provided a retrospective report of falls in postal questionnaires mailed every 4 months. A separate randomization allocated participants to receive prospective monthly falls diaries for one simultaneous 4-month period. RESULTS: Falls diaries were returned by 7,762 of 9,375 (83%); of which 6,306 (67%) participants reported the same number of falls on both data sources. Diary nonresponders were older and had poorer levels of physical and mental health. Analysis of time points where both data sources were available showed the falls rate on diaries was consistently higher than on the questionnaire (mean rate: 0.16 vs. 0.12 falls per person-month observation). Diary allocation was associated with a higher rate of withdrawal from the main trial. CONCLUSION: Diary completion was associated with sample attrition. We found on average a 32% difference in falls rates between the two data sources. Retrospective and prospective falls data are not consistently reported when collected simultaneously.

Exercise rehabilitation programmes for pulmonary hypertension: a systematic review of intervention components and reporting quality.

OBJECTIVES: To identify the components, and assess the reporting quality, of exercise training interventions for people living with pulmonary hypertension. DESIGN: Systematic review with analysis of intervention reporting quality using the Consensus on Exercise Reporting Template (CERT). DATA SOURCES: Eligible studies in the Cochrane Systematic Review of exercise-based rehabilitation for pulmonary hypertension, updated with a new search of relevant databases from 1 August 2016 to 15 January 2018. ELIGIBILITY CRITERIA: Peer-reviewed journal articles of randomised and non-randomised controlled trials, and non-controlled prospective observational studies, investigating dynamic exercise training interventions in adult humans with diagnosed pulmonary hypertension, reporting on at least one physiological and/or psychosocial outcome. RESULTS: Interventions typically involved cycle ergometry and walking. They were delivered as 3-week inpatient, or outpatient and/or home-based programmes, lasting for 4-15 weeks. Components relating specifically to exercise prescription were described satisfactorily and in more detail than motivational/behavioural change strategies, adherence and fidelity. Mean CERT score was 13.1 (range 8-17) out of a possible maximum score of 19. No studies fully reported every aspect of an exercise intervention to the standard recommended by CERT. SUMMARY/CONCLUSION: Considerable variability was evident in the components and reporting quality of interventions for exercise rehabilitation studies in pulmonary hypertension. Interventional studies using exercise training should pay greater attention to describing motivational/behavioural change strategies, adherence and fidelity. Detailed description of these parameters is essential for the safe and effective replication of exercise rehabilitation interventions for pulmonary hypertension in clinical practice. TRIAL REGISTRATION NUMBER: CRD42018085558.

The Consensus on Exercise Reporting Template (CERT) applied to exercise interventions in musculoskeletal trials demonstrated good rater agreement and incomplete reporting.

OBJECTIVE: To determine inter-rater agreement and utility of the Consensus on Exercise Reporting Template (CERT) for evaluating reporting of musculoskeletal exercise trials. STUDY DESIGN AND SETTING: Two independent reviewers applied the CERT to a random sample of 20 exercise trials published 2010 to 2015 identified from searches of PEDro, CENTRAL, and PubMed. Reviewers recorded whether each item criterion was met and detailed missing data, and appraisal time percent agreement and the Prevalence and Bias Adjusted Kappa (PABAK) statistic were used to measure inter-rater agreement. RESULTS: The trials included a range of musculoskeletal conditions (back/neck pain, hip/knee osteoarthritis, tendinopathies). For percent agreement, inter-rater agreement was high (13 items ≥80%) and for PABAK substantial (nine items: 0.61-0.80) and excellent (three items: 0.81-1.0). Agreement was lower for starting level decision rule (percent agreement: 55%, PABAK 0.30); tailoring of exercise (%A: 65%, PABAK 0.40 [95% CI: 0.00 to 0.80]); exercise equipment (percent agreement: 70%, PABAK 0.30); and motivation strategies (percent agreement: 70%, PABAK 0.40). Sixty percent of descriptions were missing information for ≥50% of CERT items. Mean appraisal time was 30 minutes, and the majority of interventions required access to other published papers. CONCLUSIONS: The CERT has good inter-rater agreement and can comprehensively evaluate reporting of exercise interventions. Most trials do not adequately report intervention details, and information can be difficult to obtain. Incomplete reporting of effective exercise programs may be remedied by using the CERT when constructing, submitting, reviewing, and publishing articles.

Aerobic and strength training exercise programme for cognitive impairment in people with mild to moderate dementia: the DAPA RCT.

BACKGROUND: Approximately 670,000 people in the UK have dementia. Previous literature suggests that physical exercise could slow dementia symptom progression. OBJECTIVES: To estimate the clinical effectiveness and cost-effectiveness of a bespoke exercise programme, in addition to usual care, on the cognitive impairment (primary outcome), function and health-related quality of life (HRQoL) of people with mild to moderate dementia (MMD) and carer burden and HRQoL. DESIGN: Intervention development, systematic review, multicentred, randomised controlled trial (RCT) with a parallel economic evaluation and qualitative study. SETTING: 15 English regions. PARTICIPANTS: People with MMD living in the community. INTERVENTION: A 4-month moderate- to high-intensity, structured exercise programme designed specifically for people with MMD, with support to continue unsupervised physical activity thereafter. Exercises were individually prescribed and progressed, and participants were supervised in groups. The comparator was usual practice. MAIN OUTCOME MEASURES: The primary outcome was the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog). The secondary outcomes were function [as measured using the Bristol Activities of Daily Living Scale (BADLS)], generic HRQoL [as measured using the EuroQol-5 Dimensions, three-level version (EQ-5D-3L)], dementia-related QoL [as measured using the Quality of Life in Alzheimer's Disease (QoL-AD) scale], behavioural symptoms [as measured using the Neuropsychiatric Inventory (NPI)], falls and fractures, physical fitness (as measured using the 6-minute walk test) and muscle strength. Carer outcomes were HRQoL (Quality of Life in Alzheimer's Disease) (as measured using the EQ-5D-3L) and carer burden (as measured using the Zarit Burden Interview). The economic evaluation was expressed in terms of incremental cost per quality-adjusted life-year (QALY) gained from a NHS and Personal Social Services perspective. We measured health and social care use with the Client Services Receipt Inventory. Participants were followed up for 12 months. RESULTS: Between February 2013 and June 2015, 494 participants were randomised with an intentional unequal allocation ratio: 165 to usual care and 329 to the intervention. The mean age of participants was 77 years [standard deviation (SD) 7.9 years], 39% (193/494) were female and the mean baseline ADAS-Cog score was 21.5 (SD 9.0). Participants in the intervention arm achieved high compliance rates, with 65% (214/329) attending between 75% and 100% of sessions. Outcome data were obtained for 85% (418/494) of participants at 12 months, at which point a small, statistically significant negative treatment effect was found in the primary outcome, ADAS-Cog (patient reported), with a mean difference of -1.4 [95% confidence interval (CI) -2.62 to -0.17]. There were no treatment effects for any of the other secondary outcome measures for participants or carers: for the BADLS there was a mean difference of -0.6 (95% CI -2.05 to 0.78), for the EQ-5D-3L a mean difference of -0.002 (95% CI -0.04 to 0.04), for the QoL-AD scale a mean difference of 0.7 (95% CI -0.21 to 1.65) and for the NPI a mean difference of -2.1 (95% CI -4.83 to 0.65). Four serious adverse events were reported. The exercise intervention was dominated in health economic terms. LIMITATIONS: In the absence of definitive guidance and rationale, we used a mixed exercise programme. Neither intervention providers nor participants could be masked to treatment allocation. CONCLUSIONS: This is a large well-conducted RCT, with good compliance to exercise and research procedures. A structured exercise programme did not produce any clinically meaningful benefit in function or HRQoL in people with dementia or on carer burden. FUTURE WORK: Future work should concentrate on approaches other than exercise to influence cognitive impairment in dementia. TRIAL REGISTRATION: Current Controlled Trials ISRCTN32612072. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full programme and will be published in full in Health Technology Assessment Vol. 22, No. 28. See the NIHR Journals Library website for further project information. Additional funding was provided by the Oxford NIHR Biomedical Research Centre and the Oxford NIHR Collaboration for Leadership in Applied Health Research and Care.

Development and delivery of an exercise programme for falls prevention: the Prevention of Falls Injury Trial (PreFIT).

OBJECTIVE: This paper describes the development and implementation of an exercise intervention to prevent falls within The Prevention of Fall Injury Trial (PreFIT), which is a large multi-centred randomised controlled trial based in the UK National Health Service (NHS). DESIGN: Using the template for intervention description and replication (TIDieR) checklist, to describe the rationale and processes for treatment selection and delivery of the PreFIT exercise intervention. PARTICIPANTS: Based on the results of a validated falls and balance survey, participants were eligible for the exercise intervention if they were at moderate or high risk of falling. INTERVENTIONS: Intervention development was informed using the current evidence base, published guidelines, and pre-existing surveys of clinical practice, a pilot study and consensus work with therapists and practitioners. The exercise programme targets lower limb strength and balance, which are known, modifiable risk factors for falling. Treatment was individually tailored and progressive, with seven recommended contacts over a six-month period. Clinical Trials Registry (ISCTRN 71002650).

The design and development of a complex multifactorial falls assessment intervention for falls prevention: The Prevention of Falls Injury Trial (PreFIT).

BACKGROUND: This paper describes the design and development of a complex multifactorial falls prevention (MFFP) intervention for implementation and testing within the framework of a large UK-based falls prevention randomised controlled trial (RCT). METHODS: A complex intervention was developed for inclusion within the Prevention of Falls Injury Trial (PreFIT), a multicentre pragmatic RCT. PreFIT aims to compare the clinical and cost-effectiveness of three alternative primary care falls prevention interventions (advice, exercise and MFFP), on outcomes of fractures and falls. Community-dwelling adults, aged 70 years and older, were recruited from primary care in the National Health Service (NHS), England. RESULTS: Development of the PreFIT MFFP intervention was informed by the existing evidence base and clinical guidelines for the assessment and management of falls in older adults. After piloting and modification, the final MFFP intervention includes seven falls risk factors: a detailed falls history interview with consideration of 'red flags'; assessment of balance and gait; vision; medication screen; cardiac screen; feet and footwear screen and home environment assessment. This complex intervention has been fully manualised with clear, documented assessment and treatment pathways for each risk factor. Each risk factor is assessed in every trial participant referred for MFFP. Referral for assessment is based upon a screening survey to identify those with a history of falling or balance problems. Intervention delivery can be adapted to the local setting. CONCLUSION: This complex falls prevention intervention is currently being tested within the framework of a large clinical trial. This paper adheres to TIDieR and CONSORT recommendations for the comprehensive and explicit reporting of trial interventions. Results from the PreFIT study will be published in due course. The effectiveness and cost-effectiveness of the PreFIT MFFP intervention, compared to advice and exercise, on the prevention of falls and fractures, will be reported at the conclusion of the trial.

A cluster randomised controlled trial of advice, exercise or multifactorial assessment to prevent falls and fractures in community-dwelling older adults: protocol for the prevention of falls injury trial (PreFIT).

INTRODUCTION: Falls are the leading cause of accident-related mortality in older adults. Injurious falls are associated with functional decline, disability, healthcare utilisation and significant National Health Service (NHS)-related costs. The evidence base for multifactorial or exercise interventions reducing fractures in the general population is weak. This protocol describes a large-scale UK trial investigating the clinical and cost-effectiveness of alternative falls prevention interventions targeted at community dwelling older adults. METHODS AND ANALYSIS: A three-arm, pragmatic, cluster randomised controlled trial, conducted within primary care in England, UK. Sixty-three general practices will be randomised to deliver one of three falls prevention interventions: (1) advice only; (2) advice with exercise; or (3) advice with multifactorial falls prevention (MFFP). We aim to recruit over 9000 community-dwelling adults aged 70 and above. Practices randomised to deliver advice will mail out advice booklets. Practices randomised to deliver 'active' interventions, either exercise or MFFP, send all trial participants the advice booklet and a screening survey to identify participants with a history of falling or balance problems. Onward referral to 'active' intervention will be based on falls risk determined from balance screen. The primary outcome is peripheral fracture; secondary outcomes include number with at least one fracture, falls, mortality, quality of life and health service resource use at 18 months, captured using self-report and routine healthcare activity data. ETHICS AND DISSEMINATION: The study protocol has approval from the National Research Ethics Service (REC reference 10/H0401/36; Protocol V.3.1, 21/May/2013). User groups and patient representatives were consulted to inform trial design. Results will be reported at conferences and in peer-reviewed publications. A patient-friendly summary of trial findings will be published on the prevention of falls injury trial (PreFIT) website. This protocol adheres to the recommended SPIRIT Checklist. Amendments will be reported to relevant regulatory parties. TRIAL REGISTRATION NUMBER: ISRCTN 71002650; Pre-results.

Predictors of attendance to group exercise: a cohort study of older adults in long-term care facilities.

BACKGROUND: The benefits of regular exercise and physical activity are well known. Those living in long-term care are often frail, but have the potential to benefit from physical activity; yet are less likely to be offered exercise. Promoting exercise within residential and nursing homes may reduce health risks associated with inactivity in this population. The aim of this cohort study is to identify predictors of attendance at physiotherapy led exercise groups offered to older adults residing in long-term care in the United Kingdom. METHODS: One thousand and twenty three older adults residing in residential and nursing homes, were recruited to the Older People's Exercise in Residential and nursing Accommodation (OPERA) cluster randomised controlled trial. Secondary analysis of 428 adults (aged 75 to 107) randomised to twice-weekly physiotherapy-led group exercise sessions for 12 months was undertaken. Using attendance data, linear regression analysis was utilised to separately identify individual and home-level factors predictive of attendance at exercise in the residential and nursing homes. RESULTS: Of 428 older adults, 326 lived in residential homes and 102 in nursing homes. Mean age of the sample was 88.0 years and the majority of residents were female (324/428, 76%). Pre-intervention assessment suggested that most residents had moderate cognitive impairment; median (range) Mini Mental State Examination scores in residential homes were 19 (0-30) and 14 (0-29) in nursing homes. Median Geriatric Depression Scale (GDS-15) scores were 3 (0-13) and 5 (0-13) respectively, indicating low levels of depressive symptoms. Over a 12-month period, 3191 exercise groups were delivered. Mean number of groups in the residential homes was 82 and 78 in the nursing homes. Number of attendances at group exercise was 11,534/21,292 (54.2%) and 3295/6436 (51.2%) respectively. Linear regression analysis revealed that depression, social engagement, and socio-economic characteristics were significantly associated with participant attendance at exercise groups in the residential homes, but none of these factors predicted attendance at group exercise in nursing homes. CONCLUSIONS: Older people living in long-term care are receptive to participating in exercise programmes, but there are individual and home-level reasons for attendance and non-attendance.

Reporting of complex interventions in clinical trials: development of a taxonomy to classify and describe fall-prevention interventions.

BACKGROUND: Interventions for preventing falls in older people often involve several components, multidisciplinary teams, and implementation in a variety of settings. We have developed a classification system (taxonomy) to describe interventions used to prevent falls in older people, with the aim of improving the design and reporting of clinical trials of fall-prevention interventions, and synthesis of evidence from these trials. METHODS: Thirty three international experts in falls prevention and health services research participated in a series of meetings to develop consensus. Robust techniques were used including literature reviews, expert presentations, and structured consensus workshops moderated by experienced facilitators. The taxonomy was refined using an international test panel of five health care practitioners. We assessed the chance corrected agreement of the final version by comparing taxonomy completion for 10 randomly selected published papers describing a variety of fall-prevention interventions. RESULTS: The taxonomy consists of four domains, summarized as the "Approach", "Base", "Components" and "Descriptors" of an intervention. Sub-domains include; where participants are identified; the theoretical approach of the intervention; clinical targeting criteria; details on assessments; descriptions of the nature and intensity of interventions. Chance corrected agreement of the final version of the taxonomy was good to excellent for all items. Further independent evaluation of the taxonomy is required. CONCLUSIONS: The taxonomy is a useful instrument for characterizing a broad range of interventions used in falls prevention. Investigators are encouraged to use the taxonomy to report their interventions.