Hannah Carpenter

Which factors are associated with fear of falling in community-dwelling older people?

BACKGROUND fear of falling (FOF) is common in older people and associated with serious physical and psychosocial consequences. Identifying those at risk of FOF can help target interventions to both prevent falls and reduce FOF. OBJECTIVE to identify factors associated with FOF. STUDY DESIGN cross-sectional study in 1,088 community-dwelling older people aged ≥65 years. METHODS data were collected on socio-demographic characteristics, self-perceived health, exercise, risk factors for falls, FOF (Short FES-I), and functional measures. Logistic regression models of increasing complexity identified factors associated with FOF. RESULTS high FOF (Short FES-I ≥11) was reported by 19%. A simpler model (socio-demographic + falls risk factors) correctly classified as many observations (82%) as a more complex model (socio-demographic + falls risk factors + functional measures) with similar sensitivity and specificity values in both models. There were significantly raised odds of FOF in the simpler model with the following factors: unable to rise from a chair of knee height (OR: 7.39), lower household income (OR: 4.58), using a walking aid (OR: 4.32), difficulty in using public transport (OR: 4.02), poorer physical health (OR: 2.85), black/minority ethnic group (OR: 2.42), self-reported balance problems (OR: 2.17), lower educational level (OR: 2.01) and a higher BMI (OR: 1.06). CONCLUSIONS a range of factors identify those with FOF. A simpler model performs as well as a more complex model containing functional assessments and could be used in primary care to identify those at risk of FOF, who could benefit from falls prevention interventions.

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.

Exercise for reducing fear of falling in older people living in the community: Cochrane systematic review and meta-analysis

OBJECTIVE to determine the effect of exercise interventions on fear of falling in community-living people aged ≥65. DESIGN systematic review and meta-analysis. Bibliographic databases, trial registers and other sources were searched for randomised or quasi-randomised trials. Data were independently extracted by pairs of reviewers using a standard form. RESULTS thirty trials (2,878 participants) reported 36 interventions (Tai Chi and yoga (n = 9); balance training (n = 19); strength and resistance training (n = 8)). The risk of bias was low in few trials. Most studies were from high-income countries (Australia = 8, USA = 7). Intervention periods (<12 weeks = 22; 13-26 weeks = 7; >26 weeks = 7) and exercise frequency (1-3 times/week = 32; ≥4 times/week = 4) varied between studies. Fear of falling was measured by single-item questions (7) and scales measuring falls efficacy (14), balance confidence (9) and concern or worry about falling (2). Meta-analyses showed a small to moderate effect of exercise interventions on reducing fear of falling immediately post-intervention (standardised mean difference (SMD) 0.37, 95% CI 0.18, 0.56; 24 studies; low-quality evidence). There was a small, but not statistically significant effect in the longer term (<6 months (SMD 0.17, 95% CI -0.05, 0.38 (four studies) and ≥6 months post-intervention SMD 0.20, 95% CI -0.01, 0.41 (three studies)). CONCLUSIONS exercise interventions probably reduce fear of falling to a small to moderate degree immediately post-intervention in community-living older people. The high risk of bias in most included trials suggests findings should be interpreted with caution. High-quality trials are needed to strengthen the evidence base in this area.

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

Promoting physical activity in older people in general practice: ProAct65+ cluster randomised controlled trial

BACKGROUND Regular physical activity reduces falls, hip fractures, and all-cause mortality, but physical activity levels are low in older age groups. AIM To evaluate two exercise programmes promoting physical activity among older people. DESIGN AND SETTING Pragmatic three-arm, parallel-design cluster randomised controlled trial involving 1256 people aged ≥65 years (of 20 507 invited) recruited from 43 general practices in London, Nottingham, and Derby. METHOD Practices were randomised to the class-based Falls Management Exercise programme (FaME), the home-based Otago Exercise Program (OEP), or usual care. The primary outcome was the proportion reaching the recommended physical activity target 12 months post-intervention. Secondary outcomes included falls, quality of life, balance confidence, and costs. RESULTS In total, 49% of FaME participants reached the physical activity target compared with 38% for usual care (adjusted odds ratio 1.78, 95% confidence interval [CI] =1.11 to 2.87, P = 0.02). Differences between FaME and usual care persisted 24 months after intervention. There was no significant difference comparing those in the OEP (43% reaching target at 12 months) and usual-care arms. Participants in the FaME arm added around 15 minutes of moderate-to-vigorous physical activity per day to their baseline level; this group also had a significantly lower rate of falls (incident rate ratio 0.74, 95% CI = 0.55 to 0.99, P = 0.042). Balance confidence was significantly improved in both intervention arms. The mean cost per extra person achieving the physical activity target was £1740. Attrition and rates of adverse reactions were similar. CONCLUSION The FaME programme increases self-reported physical activity for at least 12 months post-intervention and reduces falls in people aged ≥65 years, but uptake is low. There was no statistically significant difference in reaching the target, or in falls, between the OEP and usual-care arms.

Randomised controlled trial of the effectiveness of community group and home-based falls prevention exercise programmes on bone health in older people: the ProAct65+ bone study

BACKGROUND exercise can reduce osteoporotic fracture risk by strengthening bone or reducing fall risk. Falls prevention exercise programmes can reduce fall incidence, and also include strengthening exercises suggested to load bone, but there is little information as to whether these programmes influence bone mineral density (BMD) and strength. OBJECTIVE to evaluate the skeletal effects of home (Otago Exercise Programme, OEP) and group (Falls Exercise Management, FaME) falls prevention exercise programmes relative to usual care in older people. METHODS men and women aged over 65 years were recruited through primary care. They were randomised by practice to OEP, FaME or usual care. BMD, bone mineral content (BMC) and structural properties were measured in Nottingham site participants before and after the 24-week intervention. RESULTS participants were 319 men and women, aged mean(SD) 72(5) years. Ninety-two percentage of participants completed the trial. The OEP group completed 58(43) min/week of home exercise, while the FaME group completed 39(16) and 30(24) min/week of group and home exercise, respectively. Femoral neck BMD changes did not differ between treatment arms: mean (95% CI) effect sizes in OEP and FaME relative to usual care arm were -0.003(-0.011,0.005) and -0.002(-0.010,0.005) g cm(-2), respectively; P = 0.44 and 0.53. There were no significant changes in BMD or BMC at other skeletal sites, or in structural parameters. CONCLUSIONS falls prevention exercise programmes did not influence BMD in older people. To increase bone strength, programmes may require exercise that exerts higher strains on bone or longer duration.

Home-based pre-surgical psychological intervention for knee osteoarthritis (HAPPiKNEES): a feasibility randomized controlled trial

Objective: To determine the feasibility of conducting a trial of a pre-surgical psychological intervention on pain, function, and mood in people with knee osteoarthritis listed for total knee arthroplasty. Design: Multi-centre, mixed-methods feasibility randomized controlled trial of intervention plus usual care versus usual care. Setting: Participants’ homes or hospital. Participants: Patients with knee osteoarthritis listed for total knee arthroplasty and score >7 on either subscales of Hospital Anxiety and Depression Scale. Intervention: Up-to 10 sessions of psychological intervention (based on cognitive behavioural therapy). Main measures: Feasibility outcomes (recruitment and retention rates, acceptability of trial procedures and intervention, completion of outcome measures), and standardized questionnaires assessing pain, function, and mood at baseline, and four and six months post-randomisation. Results: Of 222 people screened, 81 did not meet inclusion criteria, 64 did not wish to participate, 26 were excluded for other reasons, and 51 were randomized. A total of 30 completed 4-month outcomes and 25 completed 6-month outcomes. Modal number of intervention sessions completed was three (range 2–8). At 6-month follow-up, mood, pain, and physical function scores were consistent with clinically important benefits from intervention, with effect sizes ranging from small (d = 0.005) to moderate (d = 0.74), and significant differences in physical function between intervention and usual care groups (d = 1.16). Feedback interviews suggested that participants understood the rationale for the study, found the information provided adequate, the measures comprehensive, and the intervention acceptable. Conclusion: A definitive trial is feasible, with a total sample size of 444 people. Pain is a suitable primary outcome, but best assessed 6 and 12 months post-surgery.

PHysical activity Implementation Study In Community-dwelling AduLts (PHISICAL): study protocol

Background Falls in older people are a leading causes of unintentional injury. Due to an ageing population, injuries are likely to increase unless more is done to reduce older people’s falls risk. In clinical trials, the Falls Management Exercise (FaME) programme has reduced the rate of falls and falls-related injuries in community-dwelling older adults. However, the commissioning of FaME is inconsistent across England, potentially due to a lack of evidence that FaME can be delivered effectively in a ‘real world’ setting. The PHysical activity Implementation Study In Community-dwelling AduLts (PHISICAL) study is designed to study the implementation of FaME in a range of different settings in England. Methods The PHISICAL study will use a mixed-methods, triangulation, multilevel design to explore the implementation of FaME. Framework analysis of semistructured interviews with up to 90 stakeholders (exercise programme users, service providers, referrers and commissioners) and observational data from locally led communities of practice will identify the factors that influence FaME’s implementation. Quantitative, anonymised, routine service data from up to 650 exercise programme users, including measures of falls and physical activity, will allow assessment of whether the benefits of FaME reported in clinical trials translate to the ‘real world’ setting. Conclusion The findings from this study will be used to develop a toolkit of resources and guidance to inform the commissioning and delivery of future FaME programmes. This study has the potential to inform public health prevention strategies, and in doing so may reduce the number of falls in the older population while delivering cost savings to health and social care services.

Can exercise protect against vertebral deformity? The proact65+bone study [Abstract]

S OF OSTEOPOROSIS CONFERENCE 2016 Invited Plenary Lecture Abstracts IS1 FROM FAMILY HISTORY TO EPIGENETICS OF OSTEOPOROSIS Trevor Cole West Midlands Regional Genetics Service and Birmingham Health Partners, Birmingham Women’s Hospital NHS Foundation Trust, Birmingham, UK With the development of greater genetic knowledge and the advent of more powerful genomic technologies there has been a greater impetus to develop more personalised service delivery and treatments for both rare diseases and common disorders. The “flagship” of such developments was in the field of oncology but similar models are now widespread and this includes disorders associated with bone fragility. Osteoporosis in the general population most frequently presents as an isolated finding, but to date, when presenting to a combined bone and genetic clinic is more likely to be seen as “compounding morbidity” in a patient or family with one of the many different rare causes of bone fragility such as osteogenesis imperfecta. Over 140 such rare bone fragility conditions are listed on the London dysmorphology database. These may present antenataly right through into old age, each with differing severity but often exacerbated by osteoporosis in those surviving into adulthood. One important lesson learnt from such clinical experience is that taking a good clinical history, including a family history, not a reliance on genomic testing, is frequently the most valuable first step in recognising the aetiology and identifying whether other family members should be seen in clinic. In past decades genetic studies in osteoporosis focused on large genomic wide association studies or rare Mendelian families in the belief that a small number of genes would be identified as the cause for more widespread osteoporosis in the general population. It was hoped such findings could be translated into simple algorithms to predict future osteoporotic risk as well as identifying novel therapeutic targets. More recently it has become apparent that this is an over-simplification and not only are there many more genetic influences present than originally suspected, but that many of these may relate to epigenetic phenomena, a mechanism by which gene expression may be modified. This now opens up a whole new therapeutic opportunity as our epigenome is modifiable by many pharmacological and nonpharmacological interventions. It also likely provides new insights into the mechanisms behind well recognised influences on osteoporosis such as physical activity. While basic research continues to focus on the genomic and epigenomic basis of osteoporosis and bone fragility disorders we will illustrate there is still plenty of scope to introduce simple practical measures, such as taking a family history, into the clinic which will improve the clinical management as well as identifying potential patient cohorts to participate in studies investigating the aetiology and future therapeutic trials. IS2 DIABETES AND BONE Serge Ferrari Geneva University Hospital and Faculty of Medicine, Geneva, Switzerland Type 1 diabetes that develops during childhood or adolescence impairs bone formation and thereby peak bone mass acquisition. Taken together with their increased risk of falls due to other diabetes complications, these bone alterations in adults with type 1 diabetes result in a 6 to 12 fold increased risk of hip fractures and also in a higher risk of vertebral and non-vertebral fractures. This increased fracture probability is also reflected in the FRAX tool when it is used without BMD in T1DM subjects. Subjects with type 2 diabetes (T2DM) also have a 50 % to two fold increased risk of fracture, depending on the skeletal site, despite the fact their aBMD is on average higher than in the non-diabetic population. Their increased Osteoporos Int (2016) 27 (Suppl 2):S609–S685 DOI 10.1007/s00198-016-3743-zThis is an abstract of a paper presented at the Osteoporosis Conference 2016, Birmingham, UK, 7-9 November 2016. The final publication is available at link.springer.com via http://dx.doi.org/10.1007/s00198-016-3743-z.This is an abstract of a paper presented at the Osteoporosis Conference 2016, Birmingham, UK, 7-9 November 2016. The final publication is available at link.springer.com via http://dx.doi.org/10.1007/s00198-016-3743-z.