Condition category
Mental and Behavioural Disorders
Date applied
23/05/2007
Date assigned
31/05/2007
Last edited
07/06/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
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 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.

Who can participate?
Permanent residents aged 65 or over in 77 residential or nursing homes in north east London and central England.

What does the study involve?
All able residents of all participating homes are invited to participate in a brief assessment lasting 15-20 minutes, measuring cognitive function, mobility, pain and quality of life. Participating homes are randomly allocated to either the exercise intervention or a comparison group. In the comparison group homes we implement a 'depression awareness programme' whereby we deliver brief-in house training to staff on recognising and managing depression, backed up by posters and leaflets and regular contact with study team members. In the exercise intervention group homes we implement a strategy to 'normalise' exercise into their daily routines. In addition to the depression awareness programme outlined above we provide a physical activation programme and a group-based exercise programme. The aim of the physical activation programme is to improve knowledge and awareness of the benefits of physical activity. We work with the managers at the homes and provide a review of mobility safety ensuring that appropriate walking aids and footwear are available to all residents. We work with the homes to review policies and strategies in place to promote physical activity and we identify a physical activity ‘champion’ within the home who will serve as the main point of contact with the therapist and undertake a regular review of the organisation’s progress. The group-based exercise programme is run by specially trained physiotherapists who run bi-weekly exercise classes in the homes. All residents are encouraged to attend these classes. Classes are appropriate to the levels of mobility of the residents. Before each class a brief risk assessment is carried out on each resident to assess their ability to participate. Classes last between 40 minutes to one hour.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Barts and The London NHS Trust (UK)

When is the study starting and how long is it expected to run for?
February 2008 to July 2011

Who is funding the study?
Health Technology Assessment Programme (UK)

Who is the main contact?
Prof. Martin Underwood
m.underwood@qmul.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Martin Underwood

ORCID ID

Contact details

Centre for Health Sciences
Abernethy Building
2 Newark Street
Barts and The London NHS Trust
Whitechapel
London
E1 2AT
United Kingdom
+44 (0)20 7882 2511
m.underwood@qmul.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 06/02/01

Study information

Scientific title

Older People's Exercise intervention in Residential and nursing Accommodation

Acronym

OPERA

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?

More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/060201
Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0015/51270/PRO-06-02-01.pdf

Ethics approval

Joint University College London/University College London Hospital Committees on the Ethics of Human Research, 30/04/2007, ref: 07/Q0505/56

Study design

Cluster randomised trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Depression

Intervention

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.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

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 measures

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.

Overall trial start date

01/02/2008

Overall trial end date

31/07/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

Approximately 1000 (residents of 80 residential and nursing homes)

Participant exclusion criteria

Terminal or other serious illness

Recruitment start date

01/02/2008

Recruitment end date

31/07/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Barts and The London NHS Trust
London
E1 2AT
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
-
Sheila.Greener@doh.gsi.gov.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/en/index.htm

Funders

Funder type

Government

Funder name

Health Technology Assessment Programme

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21288340
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21288341
3. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23643112
4. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23632142

Publication citations

  1. Protocol

    Underwood M, Eldridge S, Lamb S, Potter R, Sheehan B, Slowther AM, Taylor S, Thorogood M, Weich S, The OPERA trial: protocol for a randomised trial of an exercise intervention for older people in residential and nursing accommodation., Trials, 2011, 12, 27, doi: 10.1186/1745-6215-12-27.

  2. Results

    Ellard DR, Taylor SJ, Parsons S, Thorogood M, The OPERA trial: a protocol for the process evaluation of a randomised trial of an exercise intervention for older people in residential and nursing accommodation., Trials, 2011, 12, 28, doi: 10.1186/1745-6215-12-28.

  3. Results

    Underwood M, Lamb SE, Eldridge S, Sheehan B, Slowther AM, Spencer A, Thorogood M, Atherton N, Bremner SA, Devine A, Diaz-Ordaz K, Ellard DR, Potter R, Spanjers K, Taylor SJ, Exercise for depression in elderly residents of care homes: a cluster-randomised controlled trial., Lancet, 2013, 382, 9886, 41-49, doi: 10.1016/S0140-6736(13)60649-2.

  4. Results

    Underwood M, Lamb SE, Eldridge S, Sheehan B, Slowther A, Spencer A, Thorogood M, Atherton N, Bremner SA, Devine A, Diaz-Ordaz K, Ellard DR, Potter R, Spanjers K, Taylor SJ, Exercise for depression in care home residents: a randomised controlled trial with cost-effectiveness analysis (OPERA)., Health Technol Assess, 2013, 17, 18, 1-281, doi: 10.3310/hta17180.

Additional files

Editorial Notes

07/06/2016: Plain English summary added.