Susie Dinan

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.

Multi-centre cluster randomised trial comparing a community group exercise programme with home based exercise with usual care for people aged 65 and over in primary care: protocol of the ProAct 65+ trial

BackgroundRegular physical activity reduces the risk of mortality from all causes, with a powerful beneficial effect on risk of falls and hip fractures. However, physical activity levels are low in the older population and previous studies have demonstrated only modest, short-term improvements in activity levels with intervention.Design/MethodsPragmatic 3 arm parallel design cluster controlled trial of class-based exercise (FAME), home-based exercise (OEP) and usual care amongst older people (aged 65 years and over) in primary care. The primary outcome is the achievement of recommended physical activity targets 12 months after cessation of intervention. Secondary outcomes include functional assessments, predictors of exercise adherence, the incidence of falls, fear of falling, quality of life and continuation of physical activity after intervention, over a two-year follow up. An economic evaluation including participant and NHS costs will be embedded in the clinical trial.DiscussionThe ProAct65 trial will explore and evaluate the potential for increasing physical activity among older people recruited through general practice. The trial will be conducted in a relatively unselected population, and will address problems of selective recruitment, potentially low retention rates, variable quality of interventions and falls risk.Trial RegistrationTrial Registration: ISRCTN43453770

Completion and Return of Fall Diaries Varies With Participants’ Level of Education, First Language, and Baseline Fall Risk

BACKGROUND Consensus guidelines recommend the use of prospective fall diaries in studies of fall rates. We sought to determine the characteristics associated with return and successful completion of a falls diary and whether characteristics such as gender, education level, native language, income, and falls risk influenced self-reported fall rates. METHODS Two hundred and seventy people aged 65 years and older participating in a randomized controlled trial evaluating two exercise programmes. Fall diaries were collected for 6 months, then evaluated for correct completion and falls reported. RESULTS An increasing risk of falls was associated with a reducing odds of returning diaries (odds ratio for a one unit increase in Falls Risk Assessment Tool score 0.71, 95% confidence interval 0.53-0.96). Native English speakers were more likely to complete more than half the diaries correctly (odds ratio 2.63, 95% confidence interval 1.20-5.75). CONCLUSIONS Problems arise in the correct completion of falls diaries among those for whom English is not their first language. Diaries may underreport the rate of falls as those at higher risk were less likely to return diaries but more likely to report falls. Careful consideration should be given to the analysis of falls diaries as missing data are unlikely to be missing completely at random. We recommend additional training in the use of falls diaries for these groups or the utilization of simpler instruments.