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| [ Print-friendly version ] |
| Older People's Exercise intervention in Residential and nursing Accommodation |
| ISRCTN | ISRCTN43769277 |
| ClinicalTrials.gov identifier | |
| Public title | Older People's Exercise intervention in Residential and nursing Accommodation |
| Scientific title | |
| Acronym | OPERA |
| Serial number at source | HTA 06/02/01 |
| Study hypothesis |
This study will explore depression levels amongst residents of residential and nursing homes and the impact of a whole-home intervention on the rates of depression over a 12-month period.
Hypothesis: What is the effectiveness and cost-effectiveness of a whole home physical activity intervention to reduce depression in older people in residential and nursing homes? |
| Ethics approval | Ethical approval granted on 30 April 2007 by the Joint University College London/University College London Hospital Committees on the Ethics of Human Research. Reference number 07/Q0505/56. |
| Study design | Cluster randomised trial. |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Depression |
| Participants - inclusion criteria |
Assessment:
1. Permanent resident in residential or nursing home 2. Aged 65 or over 3. Consent/assent to assessment 4. Able to participate in baseline assessment Record check: 5. Consent/assent Exercise classes: 6. Able to transfer (with assistance from one person) from a wheelchair to a chair |
| Participants - exclusion criteria |
Terminal or other serious illness
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| Anticipated start date | 01/02/2008 |
| Anticipated end date | 31/07/2011 |
| Status of trial | Ongoing |
| Patient information material | |
| Target number of participants | Approximately 1000 (residents of 80 residential and nursing homes) |
| Interventions |
All able residents of all participating homes will be invited to participate in a brief baseline assessment lasting 15-20 minutes, measuring cognitive function, mobility, pain and quality of life. We will also seek consent/assent to complete a record check allowing us to collect data on medication, injurious falls and routine data.
After all baseline assessments have been done, we will randomise the homes and run the interventions for 12 months. Control intervention homes: We will implement a 'depression awareness programme' in control homes whereby we will deliver brief-in house training to staff on recognising and managing depression. This will be backed up by posters and leaflets and regular contact with study team members. Active intervention homes: We will implement a whole-home strategy in order to 'normalise' exercise into the daily routines of the homes. In addition the depression awareness programme outlined above we will provide a double-pronged intervention - a physical activation programme and a group-based exercise programme. The physical activation programme will aim to: 1. Improve knowledge and awareness of the benefits of physical activity to residents, staff and relatives of residents. 2. We will work with managers at homes and provide an individualised review of mobility safety ensuring that appropriate walking aids and footwear are available to all individuals. 3. We will work with the homes to review policies and strategies in place to promote physical activity 4. We will identify a physical activity ‘champion’ within the home who will serve as the main point of contact with the therapist and undertake regular review of the organisation’s progress. The group-based exercise programme will be run by specially trained physiotherapists who will run bi-weekly exercise classes in the homes. All residents will be encouraged to attend these classes. Classes will be appropriate to the levels of mobility of residents. Before each class a brief risk assessment will be carried out on each individual to assess their ability to participate. Classes will last between 40 minutes to one hour. |
| Primary outcome measure(s) | Impact of the exercise intervention on depression levels measured through the use of the Geriatric Depression Scale (GDS) -15 at baseline and 12 months for all participants. For those who score highly on the GDS-15, we will also interview them at the 6-month stage in addition to the 2 timepoints for all residents. |
| Secondary outcome measure(s) |
1. Quality of life measured by EueroQoL 5 dimensions (EQ5D) at baseline and 12 months for all participants, and in addition at 6 months for those who score highly on the GDS-15.
2. Mobility measured by the Short Physical Performance Battery (SPPB) at baseline and 12 months for all participants, and in addition at 6 months for those who score highly on the GDS-15. 3. Injurious falls measured through home and hospital records. This will be collected at baseline, 3, 6, 9 and 12 months. 4. Cognitive function measured by the Mini Mental State Examination (MMSE) at baseline and 12 months for all participants, and in addition at 6 months for those who score highly on the GDS-15. 5. Pain, measured through participants' self reported level of pain on a five point scale at baseline and 12 months for all participants, and in addition at 6 months for those who score highly on the GDS-15. 6. Medication use, measured through their home records. This will be collected at baseline, 3, 6, 9 and 12 months. 7. Hospital Admissions. We will extract data on cause and duration of any hospital admissions during the study period from participants’ hospital records. |
| Sources of funding | NIHR Health Technology Assessment Programme - HTA (UK) |
| Trial website | |
| Publications | |
| Contact name | Prof Martin Underwood |
| Address |
Centre for Health Sciences
Abernethy Building 2 Newark Street Barts and The London NHS Trust Whitechapel |
| City/town | London |
| Zip/Postcode | E1 2AT |
| Country | United Kingdom |
| Tel | +44 (0) 20 7882 2511 |
| Fax | +44 (0) 20 7882 2552 |
| m.underwood@qmul.ac.uk | |
| Sponsor | Department of Health (UK) |
| Address |
Quarry House
Quarry Hill |
| City/town | Leeds |
| Zip/Postcode | LS2 7UE |
| Country | United Kingdom |
| Sheila.Greener@doh.gsi.gov.uk | |
| Sponsor website: | http://www.dh.gov.uk/en/index.htm |
| Date applied | 23/05/2007 |
| Last edited | 26/08/2009 |
| Date ISRCTN assigned | 31/05/2007 |
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