Sheena Gawler

Multicentre cluster randomised trial comparing a community group exercise programme and home-based exercise with usual care for people aged 65 years and over in primary care

BACKGROUND Regular physical activity (PA) reduces the risk of falls and hip fractures, and mortality from all causes. However, PA levels are low in the older population and previous intervention studies have demonstrated only modest, short-term improvements. OBJECTIVE To evaluate the impact of two exercise promotion programmes on PA in people aged ≥ 65 years. DESIGN The ProAct65+ study was a pragmatic, three-arm parallel design, cluster randomised controlled trial of class-based exercise [Falls Management Exercise (FaME) programme], home-based exercise [Otago Exercise Programme (OEP)] and usual care among older people (aged ≥ 65 years) in primary care. SETTING Forty-three UK-based general practices in London and Nottingham/Derby. PARTICIPANTS A total of 1256 people ≥ 65 years were recruited through their general practices to take part in the trial. INTERVENTIONS The FaME programme and OEP. FaME included weekly classes plus home exercises for 24 weeks and encouraged walking. OEP included home exercises supported by peer mentors (PMs) for 24 weeks, and encouraged walking. MAIN OUTCOME MEASURES The primary outcome was the proportion that reported reaching the recommended PA target of 150 minutes of moderate to vigorous physical activity (MVPA) per week, 12 months after cessation of the intervention. Secondary outcomes included functional assessments of balance and falls risk, the incidence of falls, fear of falling, quality of life, social networks and self-efficacy. An economic evaluation including participant and NHS costs was embedded in the clinical trial. RESULTS In total, 20,507 patients from 43 general practices were invited to participate. Expressions of interest were received from 2752 (13%) and 1256 (6%) consented to join the trial; 387 were allocated to the FaME arm, 411 to the OEP arm and 458 to usual care. Primary outcome data were available at 12 months after the end of the intervention period for 830 (66%) of the study participants. The proportions reporting at least 150 minutes of MVPA per week rose between baseline and 12 months after the intervention from 40% to 49% in the FaME arm, from 41% to 43% in the OEP arm and from 37.5% to 38.0% in the usual-care arm. A significantly higher proportion in the FaME arm than in the usual-care arm reported at least 150 minutes of MVPA per week at 12 months after the intervention [adjusted odds ratio (AOR) 1.78, 95% confidence interval (CI) 1.11 to 2.87; p = 0.02]. There was no significant difference in MVPA between OEP and usual care (AOR 1.17, 95% CI 0.72 to 1.92; p = 0.52). Participants in the FaME arm added around 15 minutes of MVPA per day to their baseline physical activity level. In the 12 months after the close of the intervention phase, there was a statistically significant reduction in falls rate in the FaME arm compared with the usual-care arm (incidence rate ratio 0.74, 95% CI 0.55 to 0.99; p = 0.042). Scores on the Physical Activity Scale for the Elderly showed a small but statistically significant benefit for FaME compared with usual care, as did perceptions of benefits from exercise. Balance confidence was significantly improved at 12 months post intervention in both arms compared with the usual-care arm. There were no statistically significant differences between intervention arms and the usual-care arm in other secondary outcomes, including quality-adjusted life-years. FaME is more expensive than OEP delivered with PMs (£269 vs. £88 per participant in London; £218 vs. £117 in Nottingham). The cost per extra person exercising at, or above, target was £1919.64 in London and £1560.21 in Nottingham (mean £1739.93). CONCLUSION The FaME intervention increased self-reported PA levels among community-dwelling older adults 12 months after the intervention, and significantly reduced falls. Both the FaME and OEP interventions appeared to be safe, with no significant differences in adverse reactions between study arms. TRIAL REGISTRATION This trial is registered as ISRCTN43453770. FUNDING This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 18, No. 49. See the NIHR Journals Library website for further project information.

Reducing falls among older people in general practice: The ProAct65+exercise intervention trial

BACKGROUND Falls are common in the older UK population and associated costs to the NHS are high. Systematic reviews suggest that home exercise and group-based exercise interventions, which focus on progressively challenging balance and increasing strength, can reduce up to 42% of falls in those with a history of falls. The evidence is less clear for those older adults who are currently at low risk of falls. AIM ProAct65+, a large, cluster-randomised, controlled trial, investigated the effectiveness of a home exercise programme (Otago Exercise Programme (OEP)) and a group-based exercise programme (Falls Management Exercise (FaME)) compared to usual care (UC) at increasing moderate to vigorous physical activity (MVPA). This paper examines the trials secondary outcomes; the effectiveness of the interventions at reducing falls and falls-related injuries. SETTING & PARTICIPANTS 1256 community-dwelling older adults (aged 65+) were recruited through GP practices in two sites (London and Nottingham). Frequent fallers (≥3 falls in last year) and those with unstable medical conditions were excluded, as were those already reaching the UK Government recommended levels of physical activity (PA) for health. METHODS Baseline assessment (including assessment of health, function and previous falls) occurred before randomisation; the intervention period lasted 24 weeks and there was an immediate post-intervention assessment; participants were followed up every six months for 24 months. Falls data were analysed using negative binomial modelling. OUTCOME MEASURES Falls data were collected prospectively during the intervention period by 4-weekly diaries (6 in total). Falls recall was recorded at the 3-monthly follow-ups for a total of 24 months. Balance was measured at baseline and at the end of the intervention period using the Timed Up & Go and Functional Reach tests. Balance confidence (CONFbal), falls risk (FRAT) and falls self-efficacy (FES-I) were measured by questionnaire at baseline and at all subsequent assessment points. RESULTS 294 participants (24%) reported one or two falls in the previous year. There was no increase in falls in either exercise group compared to UC during the intervention period (resulting from increased exposure to risk). The FaME arm experienced a significant reduction in injurious falls compared to UC (incidence rate ratio (IRR) 0.55, 95% CI 0.31, 0.96; p=0.04) and this continued during the 12 months after the end of the intervention (IRR 0.73, 95% CI 0.54, 0.99; p=0.05). There was also a significant reduction in the incidence of all falls (injurious and non-injurious) in the FaME arm compared with UC (IRR 0.74, 95% CI 0.55, 0.99; p=0.04) in the 12 month period following the cessation of the intervention. There was a non-significant reduction in the incidence of all falls in the OEP arm compared with UC (IRR 0.76, 95% CI 0.53, 1.09; p=0.14) in the 12 months following the cessation of the intervention. The effects on falls did not persist at the 24 months assessment in either exercise arm. However, when those in the FaME group who continued to achieve 150min of MVPA per week into the second post-intervention year were compared to those in the FaME group who did not maintain their physical activity, there was a significant reduction in falls incidence (IRR=0.49, 95% CI 0.30, 0.79; p=0.004). CONFbal was significantly improved at 12 months post intervention in both intervention arms compared with UC. There were no significant changes in any of the functional balance measures, FES-I or FRAT, between baseline and the end of the intervention period. CONCLUSION Community-dwelling older adults who joined an exercise intervention (FaME) aimed at increasing MVPA did not fall more during the intervention period, fell less and had fewer injurious falls in the 12 months after cessation of the intervention. However, 24 months after cessation of exercise, the beneficial effects of FaME on falls reduction ceased, except in those who maintained higher levels of MVPA. OEP exercise appears less effective at reducing falls in this functionally more able population of older adults.

Lessons learnt during a complex, multicentre cluster randomised controlled trial: the ProAct65+ trial

BackgroundFailure to recruit to target or schedule is common in randomized controlled trials (RCTs). Innovative interventions are not always fully developed before being tested, and maintenance of fidelity to the intervention during trials can be problematic. Missing data can compromise analyses, and inaccurate capture of risks to participants can influence reporting of intervention harms and benefits.In this paper we describe how challenges of recruitment and retention of participants, standardisation and quality control of interventions and capture of adverse events were overcome in the ProAct65+ cluster RCT. This trial compared class-based and home-based exercise with usual care in people aged 65 years and over, recruited through general practice. The home-based exercise participants were supported by Peer Mentors.Results(1) Organisational factors, including room availability in general practices, slowed participant recruitment so the recruitment period was extended and the number invited to participate increased. (2) Telephone pre-screening was introduced to exclude potential participants who were already very active and those who were frequent fallers. (3) Recruitment of volunteer peer mentors was difficult and time consuming and their acceptable case load less than expected. Lowering the age limit for peer mentors and reducing their contact schedule with participants did not improve recruitment. (4) Fidelity to the group intervention was optimised by introducing quality assurance observation of classes by experienced exercise instructors. (5) Diaries were used to capture data on falls, service use and other exercise-related costs, but completion was variable so their frequency was reduced. (6) Classification of adverse events differed between research sites so all events were assessed by both sites and discrepancies discussed.ConclusionsRecruitment rates for trials in general practice may be limited by organisational factors and longer recruitment periods should be allowed for. Exercise studies may be attractive to those who least need them; additional screening measures can be employed to avoid assessment of ineligible participants. Enrolment of peer mentors for intervention support is challenging and needs to be separately tested for feasibility. Standardisation of exercise interventions is problematic when exercise programmes are tailored to participants’ capabilities; quality assurance observations may assure fidelity of the intervention. Data collection by diaries can be burdensome to participants, resulting in variable and incomplete data capture; compromises in completion frequency may reduce missing data. Risk assessments are essential in exercise promotion studies, but categorisation of risks can vary between assessors; methods for their standardisation can be developed.Trial registrationISRCTN43453770

Visually Impaired OLder people's Exercise programme for falls prevenTion (VIOLET): a feasibility study protocol

Introduction In the UK, 1 in 5 people aged 75 and over live with sight loss. Visually impaired older people (VIOP) have an above average incidence of falls and 1.3–1.9 times more likely to experience hip fractures, than the general population. Older people with eye diseases are ∼3 times more likely than those with good vision, to limit activities due to fear of falling. This feasibility study aims to adapt the group-based Falls Management Exercise (FaME) programme to the needs of VIOP and carry out an external pilot trial to inform the design of a future definitive randomised controlled trial. Methods and design A UK based 2-centre mixed methods, randomised, feasibility study will be conducted over 28 months. Stakeholder panels, including VIOP, will make recommendations for adaptations to an existing exercise programme (FaME), to meet the needs of VIOP, promoting uptake and adherence, while retaining required effective components of the exercise programme. 80 VIOP aged 60 and over, living at home, ambulant with or without a walking aid, will be recruited in Newcastle (n=40) and Glasgow (n=40) through National Health Service (NHS) Trusts and third sector partners. Participants randomised into the intervention arm will receive the adapted FaME programme. Participants randomised into the control arm will continue with usual activity. Outcomes are, recruitment rate, adherence and validated measures including fear of falling and quality of life. Postintervention in-depth qualitative interviews will be conducted with a purposive sample of VIOP (N=10). Postural stability instructors will be interviewed, before trial-specific training and following the intervention. Ethics and dissemination Ethics approval was secured through the National Research Ethics Service (NRES) Committee North East, Newcastle and North Tyneside 2. Glasgow Caledonian University was approved as a non-NHS site with local ethics approval. Findings will be disseminated through peer-reviewed journals, national and international conferences. Trial registration number ISRCTN16949845.