Older People's Exercise intervention in Residential and nursing Accommodation (OPERA)

This is a joint proposal between the Centre for Health Sciences at Queen Mary University of London (QMUL) and the Clinical Trials Unit at Warwick Medical School. Design: Cluster randomised clinical effectiveness trial, preceded by a pilot study, with simultaneous process evaluation and cost utility analysis, and a secondary costs and consequences analysis based in residential and nursing homes (RNHs) Setting: 77 private and public sector RNHs (+ 3 pilot homes) in two localities: NE London & central England. We have active support for this project from our lead PCT in each locality. We will seek consent from the RNH's management, as guardians of the cluster, to take part in the randomised study, consent from individual residents to participate in the evaluation and separate consent from residents to participate in the exercise class component of the intervention. Target population: ALL people aged 65 or over living in residential or nursing homes except those identified by RNH staff to have a very limited life expectancy or another condition which would make participation difficult or inappropriate will be invited to participate in the study. Our exclusion criteria will be severe cognitive impairment (score of 10 or less on the Mini-Mental State Examination [MMSE]) and inability to communicate in English. All eligible residents will be invited to take part in study assessments. All residents, except those unable to transfer (with assistance from one person) from a wheelchair to chair will be invited to participate in the exercise classes; this includes residents who are not participating in the evaluation. Since mortality in this population is substantial we will have an ongoing programme of screening new residents to join the study. Health technology being assessed: Experienced physiotherapists will deliver: (1) a rolling educational programme for RNH staff to help provide an environment where residents can safely increase their physical activity, complemented by (2) a twice-weekly exercise classes for residents in each RNH, with a strong emphasis on the aerobic and social aspects of group exercise. Classes will include some residents who are not depressed; this will serve to improve the group dynamic, ensure a representative range of motivation and match how such a programme would work in 'real life'. Informed by the MRC framework for testing complex interventions, and specifically our previous work modelling a complex intervention for falls prevention, we will decide on the final components of the intervention in the pilot stage; we will then develop and refine the intervention package. The intervention builds on our previous experience of group exercise interventions and primary care staff training for musculoskeletal pain and falls prevention. Previous studies of exercise classes for depression in this group that have not included education for RNH staff have had equivocal results, and indicate that a brief intervention is likely to lose its effect in the long term. Our ongoing regular 'whole RNH' programme will maximise the possibility of demonstrating beneficial effects. Such an intervention will be built into the year-round routine of RNHs. Thus, participants recruited at baseline will be able to continue in the class for one year. In both the intervention and control RNHs we will run a rolling staff training programme, delivered by our research nurses in the control RNHs, promoting 'best usual care' around depression, i.e facilitating recognition and onward referral of depressed residents to conventional services. Measurement of costs and outcomes: We will collect outcome data on both depressed and non-depressed participants. Our primary effectiveness analyses will be based on the Geriatric Depression Scale-15 (GDS-15). Our three primary outcomes are: 1) The prevalence of depression in the nursing homes (amongst residents able to complete assessment) twelve months after randomisation. 2) The proportion of reside