Abstract
BackgroundDepression is common in residents of Residential and Nursing homes (RNHs). It is usually undetected and often undertreated. Depression is associated with poor outcomes including increased morbidity and mortality. Exercise has potential to improve depression, and has been shown in existing trials to improve outcomes among younger and older people. Existing evidence comes from trials that are short, underpowered and not from RNH settings. The aim of the OPERA trial is to establish whether exercise is effective in reducing the prevalence of depression among older RNH residents.MethodOPERA 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.DiscussionHome 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.Trial Registration[ISRCTN: ISRCTN43769277]
Highlights
Depression is common in residents of Residential and Nursing homes (RNHs)
We estimated that we needed to recruit 77 RNHs and at least 418 residents with depression at baseline to detect an increase in remission rates from 25% to 40%
We used a conservative value of 0.05 for this, which towards the upper end of the range seen in previous primary care studies. This should provide have sufficient power to allow for likely variation in cluster sizes and for likely clustering effects due to different physiotherapists carrying out the exercise programme in different RNHs
Summary
Depression is common in residents of Residential and Nursing homes (RNHs). Exercise has potential to improve depression, and has been shown in existing trials to improve outcomes among younger and older people. The aim of the OPERA trial is to establish whether exercise is effective in reducing the prevalence of depression among older RNH residents. Untreated depression is one major cause of morbidity in older people, in those who live in residential and nursing homes (RNHs). Falls are a major cause of morbidity and mortality in older people and antidepressant drugs; both tricyclics and SSRIs are associated with a two-fold increase in falls in care home residents [11]
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