Susanne Finnegan

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.

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 Alzheimers 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 Alzheimers 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 Alzheimers 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).

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.

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.