The OPERA trial: protocol for a randomised trial of an exercise intervention for older people in residential and nursing accommodation

OPERA is a cluster randomised controlled trial. RNHs are randomised to one of two groups with interventions lasting 12 monthsIntervention group: a depression awareness and physical activity training session for care home staff, plus a whole home physical activation programme including twice weekly physiotherapist-led exercise groups. The intervention lasts for one year from randomisation, orControl group: a depression awareness training session for care home staff.Participants are people aged 65 or over who are free of severe cognitive impairment and willing to participate in the study. Our primary outcome is the prevalence of depressive symptoms, a GDS-15 score of five or more, in all participants at the end of the one year intervention period. Our secondary depression outcomes include remission of depressive symptoms and change in GDS-15 scores in those with depressive symptoms prior to randomisation. Other secondary outcomes include, fear of falling, mobility, fractures, pain, cognition, costs and health related quality of life. We aimed to randomise 77 RNHs.Home recruitment was completed in May 2010; 78 homes have been randomised. Follow up will finish in May 2011 and results will be available late 2011.[ISRCTN: ISRCTN43769277]Untreated depression is one major cause of morbidity in older people, particularly in those who live in residential and nursing homes (RNHs). Up to 40% of RNH residents are depressed [1,2]. The annual incidence of depression is around 12%, with depression resolving after a year in only about half of cases [3]. In many cases the depression is not recognized by the RNH staff or by the resident's general practitioner [4,5].There is a move away from drug treatment for mild/moderate depression. Guidelines from the UK National Institute of Health and Clinical Excellence (NICE) do not recommend drug treatment for mild depression and suggest that drugs should be used only as part of a more holistic package of care for those with moderate depressio