Older People’s Exercise intervention in Residential and nursing Accommodation
Study Code / Acronym
OPERAAward Number
06/02/01Programme
Health Technology AssessmentStatus / Stage
CompletedDates
1 February 2008 -31 October 2011
Duration (calculated)
03 years 08 monthsFunder(s)
NIHRFunding Amount
£1,957,884.00Funder/Grant study page
NIHRContracted Centre
University of WarwickContracted Centre Webpage
Principal Investigator
Professor Martin UnderwoodPI Contact
M.Underwood@warwick.ac.ukPI ORCID
0000-0002-0309-1708WHO Catergories
High quality epidemiological dataMethodologies and approaches for risk reduction research
Disease Type
Mild DementiaModerate Dementia
CPEC Review Info
| Reference ID | 187 |
|---|---|
| Researcher | Reside Team |
| Published | 12/06/2023 |
Data
| Study Code / Acronym | OPERA |
|---|---|
| Award Number | 06/02/01 |
| Status / Stage | Completed |
| Start Date | 20080201 |
| End Date | 20111031 |
| Duration (calculated) | 03 years 08 months |
| Funder/Grant study page | NIHR |
| Contracted Centre | University of Warwick |
| Contracted Centre Webpage | |
| Funding Amount | £1,957,884.00 |
Abstract
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 residents identified with depression at baseline who are in remission at six months. 3) The change in the severity of depressive symptoms in residents identified with depression at baseline at twelve months.
Plain English Summary
Up to 40% of residential and nursing home residents are depressed. Both exercise and increased social interaction may have a positive effect on depression and a group exercise programme that combines a social element and improved exercise tolerance is a promising non-drug approach to managing depression. We believe that for such a programme to be maximally beneficial and sustainable residential home staff will also have to provide increased opportunities for residents to participate in safe physical activity in their daily lives. This study will examine whether a ‘whole home’ intervention, consisting of training for residential and nursing home staff and an ongoing, twice weekly, group exercise programme delivered by experienced physiotherapists reduces the overall number of residents who are depressed after one year. We will also determine whether the programme reduces depression after six and 12 months amongst those residents identified as depressed at the start of the study. Following a pilot study in three homes to refine the interventions, the study will be conducted in 77 residential or nursing homes in north east London and central England. Staff in every home in the study will receive training in best practice for depression awareness and the homes will be allocated to the exercise intervention or a comparison group at random. Individual residents in all the homes will be asked to consent to the study assessments; and residents in the homes receiving the intervention will be asked to consent separately to take part in the exercise class. Many participants will have mild/moderate dementia and may not be able to give informed consent to data collection or to participate in the exercise programme. We will explore this important issue, the use of carer assent and the acceptability of the overall study approach as part of this study. This will involve interviewing residents, staff and relatives parallel to the pilot phase of the study. The study team has considerable experience of group exercise prescriptions for older people, research in residential and nursing homes, cluster randomised trials, old age psychiatry and research ethics.