Supporting Physical Activity through Co-production in people with Severe Mental Illness (SPACES): a pragmatic randomised controlled trial
| ISRCTN | ISRCTN23019026 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23019026 |
| IRAS number | 338802 |
| Secondary identifying numbers | IRAS 338802, CPMS 62060 |
- Submission date
- 25/07/2024
- Registration date
- 07/08/2024
- Last edited
- 07/08/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Life expectancy is reduced by around 15 - 20 years for people with severe mental ill health (SMI) compared to people without SMI, and this gap is increasing. The majority of these early deaths are due to physical health problems, which are partly preventable and which are related to factors including health behaviours such as diet, smoking and physical activity. Increasing physical activity can improve physical health in everyone and The World Health Organization has said that encouraging people to be more active can be as beneficial as quitting smoking. People with SMI are less physically active than the general population. Supporting people with SMI to increase their levels of physical activity could help to reduce the life expectancy gap.
Therefore, there is a need to establish whether a physical activity programme (intervention) that is relevant to the needs of people with SMI, is practical, acceptable and useful for people with SMI.
In this study, we will explore the clinical effectiveness and cost effectiveness of a physical activity intervention we have co-designed for people living with severe mental ill health.
Who can participate?
People aged 18 years and over who have a diagnosis of schizophrenia, schizoaffective disorder or bipolar disorder.
What does the study involve?
People who agree to take part in the study will be randomly allocated to usual care, or to the physical activity intervention plus usual care. We will collect information about participants level of physical activity at the outset of the trial and at 3, 6 and 12 months to establish whether the intervention is effective at increasing the amount of physical activity performed by people with SMI. We will also examine the impact of the intervention on other outcomes relating to mental health and quality of life.
What are the possible benefits and risks of participation?
This is considered a low-risk research study.
Participants may enjoy and value contributing to research.
Participants who are randomised into the intervention plus usual care group may experience benefits from the potential increase in physical activity and reduced sedentary behaviour.
Where is the study run from?
Sheffield Health & Social Care NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
From January 2024 to March 2027
Who is funding the study?
National Institute for Health and Care Research (UK)
Who is the main contact?
Dr Emily Peckham (Chief Investigator), e.peckham@bangor.ac.uk
Contact information
Public, Scientific, Principal Investigator
Centre for Mental Health and Society, Wrexham Academic Unit, Technology Park
Wrexham
LL13 7YP
United Kingdom
 ORCID ID |
0000-0002-9377-1968 |
|---|---|
| Phone | +44 3000 847 086 |
| e.peckham@bangor.ac.uk |
Study information
| Study design | Multi-center pragmatic randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Prevention, Quality of life |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Supporting Physical Activity through Co-production in people with Severe Mental Illness (SPACES): a pragmatic randomised controlled trial of a bespoke intervention to increase levels of physical activity in people with SMI compared to usual care |
| Study acronym | SPACES full scale RCT |
| Study hypothesis | A bespoke physical activity intervention is more effective at increasing levels of physical activity in people with severe mental illness than usual care |
| Ethics approval(s) |
Approved 14/05/2024, West of Scotland REC5 (West of Scotland Research Ethics Service, Ward 11, Dykebar Hospital, Grahamston Road, PAISLEY, PA2 7DE, United Kingdom; +44 141 314 0213; WoSREC5@ggc.scot.nhs.uk), ref: 24/WS/0040 |
| Condition | Increase in physical activity in people with severe mental illness |
| Intervention | Control and intervention groups: Both groups will receive usual care. Intervention group only: The intervention comprises of two core components, weekly group-based sessions and one-to-one sessions with the physical activity coordinator. All participants allocated to the intervention, will be offered up to 18 weekly group-based sessions and up to 10 one-to-one sessions delivered by a trained physical activity coordinator. The weekly group-based session will be up to two hours in length and include three components (up to 60 minutes of physical activity, a 30-minute themed discussion and 30 minutes of social time). The physical activity component will be made up of either an outdoor walk, an indoor circuit style activity graded to the needs of the participants (e.g., resistance exercises, balance exercises, cardiovascular exercises) or a community taster session (e.g., walking football, yoga). The themed discussions will involve informal information giving/sharing, which will cover relevant topics (e.g., getting started/keeping going with physical activity, benefits of increasing physical activity and reducing sedentary behaviour, overcoming barriers/hurdles to doing physical activity, being active in everyday life, staying motivated, keeping energised, exploring local indoor and outdoor activities). Time for informal socialising will make up the final portion of the weekly group-based session. The session will be delivered in a suitable NHS or community venue and run weekly for 18 weeks. Randomisation Allocation will be through block randomisation (with random permuted blocks of various integer multiple of two size) with a separate schedule for each combination of centre and diagnosis. There will be no additional stratification factors, beside centre, and diagnosis (Schizophrenia (F20 and subcodes) vs. Schizoaffective disorder (F25 and subcodes) vs. Other psychotic and delusional disorders (not of known organic origin) (F21 – F24 and F26 – F29 and subcodes) vs. Bipolar disorder and manic episodes (F30 and F31, and subcodes)) in the randomisation sequence. The study statistician in Sheffield CTRU will generate the randomisation schedule prior to the start of the study using its own web-based in-house CTRU (SCRAM) randomisation system. |
| Intervention type | Behavioural |
| Primary outcome measure | Objective accelerometer-derived minutes per day of Moderate to Vigorous Physical Activity (MVPA) measured at 6-months post randomisation |
| Secondary outcome measures | 1. Data on physical activity (light physical activity and MVPA) and sedentary behaviour will be collected by wrist worn accelerometers at baseline, 3-, 6- and 12-months post randomisation. 2. The Simple Physical Activity Questionnaire (SIMPAQ) will be used to measure self-reported physical activity and sedentary behaviour at baseline, 3-, 6- and 12-months post randomisation. Other secondary outcomes measured at 3, 6 and 12 months: 3. Health behaviours (diet and smoking) 4. Body mass index (kg/m²) 5. Depression (PHQ-9) 6. Anxiety (GAD-7) 7. Loneliness (UCLA-3 item) 8. Health-related quality of life (EQ5D, REQoL) 9. Healthcare resource use and predictive behavioural questionnaire. |
| Overall study start date | 01/01/2024 |
| Overall study end date | 31/03/2027 |
Eligibility
| Participant type(s) | Patient, Service user |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 736 |
| Participant inclusion criteria | 1. Aged 18 years or older 2. ICD-10 or DSM-V diagnosis of SMI as documented in GP or psychiatric notes (schizophrenia (F20 and subcodes); schizoaffective disorder (F25 and subcodes); other psychotic and delusional disorders (not of organic origin) (F21-F24 and F26-F29 and subcodes); bipolar and manic episodes (F30 and F31 and subcodes)). 3. Are able to walk unaided 4. Willing to wear an accelerometer |
| Participant exclusion criteria | 1. People who lack capacity to participate 2. Primary diagnosis of drug or alcohol abuse 3. Medical contraindication of physical activity as ascertained by GP or mental health team 4. Already physically active, defined as >300 minutes/week of self-reported moderate-to-vigorous physical activity (MVPA) 5. Non-English speakers 6. People who took part in the feasibility study |
| Recruitment start date | 01/09/2024 |
| Recruitment end date | 28/02/2026 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Sheffield
S4 7QQ
United Kingdom
West Park Hospital
Edward Pease Way
Darlington
DL2 2TS
United Kingdom
Thorpe Park
Leeds
LS15 8ZB
United Kingdom
Monks Orchard Road
Beckenham
BR3 3BX
United Kingdom
Hermitage Lane
Maidstone
ME16 9PH
United Kingdom
Fieldhead Hospital
Ouchthorpe Lane
Wakefield
WF1 3SP
United Kingdom
Dryden Road
Exeter
EX2 5AF
United Kingdom
Tatchbury Mount
Calmore
Southampton
SO40 2RZ
United Kingdom
Carholme Court
Long Leys Road
Lincoln
LN1 1FS
United Kingdom
Jubilee Road
Gosforth
Newcastle upon Tyne
NE3 3XT
United Kingdom
Sponsor information
Hospital/treatment centre
Centre Court
Atlas Way
Sheffield
S4 7QQ
England
United Kingdom
| Phone | +44 114 2716310 |
|---|---|
| rdu@shsc.nhs.uk | |
| Website | http://shsc.nhs.uk/ |
"ROR" |
https://ror.org/05cn4v910 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/03/2028 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication of results in a high-impact peer-reviewed journal. Planned publication of the study protocol. |
| IPD sharing plan | The datasets generated during and/ or analysed during the current study will be available on request from Emily Peckham email: e.peckham@bangor.ac.uk |
Editorial Notes
25/07/2024: Trial's existence confirmed by NHS HRA.
