Supporting Physical Activity through Co-production in people with Severe Mental Illness: Feasibility Trial
| ISRCTN | ISRCTN83877229 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83877229 |
| IRAS number | 311668 |
| Secondary identifying numbers | IRAS 311668, CPMS 53407 |
- Submission date
- 12/07/2022
- Registration date
- 09/09/2022
- Last edited
- 24/05/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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. Practical issues in establishing such a study will also be examined.
In this study, we will explore the feasibility of a physical activity intervention we have co-designed for people living with severe mental ill health.
Who can participate?
People aged 18 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 on how many people who sign up to the study, the number of people who drop out along the way, and the number of missed sessions for the intervention. We will interview a small group of people about their experience of being part of the study.
What are the possible benefits and risks of participation?
This is considered a low-risk research study.
This is an opportunity for participants to inform the development of future research (larger trial) and 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 July 2022 to December 2024
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
Principal Investigator
Centre for Mental Health and Society
Bangor University
Wrexham Campus
Wrexham
LL13 7YP
United Kingdom
 ORCID ID |
0000-0002-9377-1968 |
|---|---|
| Phone | +44 (0)7795315062 |
| e.peckham@bangor.ac.uk |
Scientific
Centre for Mental Health and Society
Bangor University
Wrexham Campus
Wrexham
LL13 7YP
United Kingdom
| ORCID ID |
0000-0002-9377-1968 |
|---|---|
| Phone | +44 (0)7795315062 |
| e.peckham@bangor.ac.uk |
Public
Centre for Mental Health and Society
Bangor University
Wrexham Campus
Wrexham
LL13 7YP
United Kingdom
| ORCID ID |
0000-0002-9377-1968 |
|---|---|
| Phone | +44 (0)7795315062 |
| e.peckham@bangor.ac.uk |
Study information
| Study design | Multicentre feasibility randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet. |
| Scientific title | Supporting Physical Activity through Co-production in people with Severe Mental Illness (SPACES): a randomised feasibility study of an intervention aimed at increasing the physical activity of people with severe mental ill health |
| Study acronym | SPACES |
| Study objectives | 1. People with conditions like schizophrenia, schizoaffective disorder, and bipolar disorder are less physically active than those without these health conditions, and the World Health Organisation has said that being more physically active can have as big an impact on health as stopping smoking 2. To evaluate the acceptability of a bespoke intervention designed to increase physical activity and the critical parameters for the design of a definitive RCT when compared to treatment as usual |
| Ethics approval(s) | Approved 18/08/2022, West of Scotland 5 Research Ethics Committee (via Zoom; +44 (0)141 314 0213; WoSREC5@ggc.scot.nhs.uk), ref: 22/WS/0101 |
| Health condition(s) or problem(s) studied | Increasing physical activity levels in adults with severe mental ill health (SMI) |
| Intervention | Participants are randomised via block randomisation with a separate schedule for each site/centre to receive either: 1. Usual care alone 2. Usual care plus an 18-week physical activity intervention developed using a synthesis of current evidence and co-produced through public involvement members with SMI and other key stakeholders |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Acceptability of the intervention measured using: 1.1. The Acceptability Intervention Measure (AIM) at 6 months post-randomisation (intervention participants only) 1.2. Intervention uptake, attendance, and attrition throughout the study 1.3. Interviews with intervention participants and intervention facilitators at 6 months post-randomisation 2. Feasibility of a full-scale trial measured using: 2.1. Participant recruitment data at the end of recruitment 2.2. Monitoring the quantity and quality of accelerometer-derived physical activity data collected at baseline, 3 months post-randomisation, and 6 months post-randomisation 2.3. Interviews with intervention participants and intervention facilitators at 6 months post-randomisation |
| Secondary outcome measures | 1. Physical activity measured using accelerometer data at baseline, 3, and 6 months post-randomisation 2. Sedentary behaviour measured using accelerometer data at baseline, 3, and 6 months post-randomisation 3. Body mass index (BMI) calculated using height and weight measurements at baseline, 3, and 6 months post-randomisation 4. Severity of depression measured using the Patient Health Questionnaire-9 (PHQ-9) at baseline, 3, and 6 months post-randomisation 5. Severty of generalised anxiety disorder measured using the General Anxiety Disorder-7 (GAD-7) questionnaire at baseline, 3, and 6 months post-randomisation 6. Self-reported physical activity and edentary behaviour measured using the Simple Physical Activity Questionnaire (SIMPAQ) at baseline, 3, and 6 months post-randomisation 7. Health-related quality-of-life measured using the EuroQoL 5D-5L (EQ5D-5L) questionnaire at baseline, 3, and 6 months post-randomisation 8. Health-related quality-of-life measured using the Short Form Health Questionnaire - 12 (SF-12) at baseline, 3, and 6 months post-randomisation 9. Mental health-related quality-of-life measured using the Recovering Quality of Life (ReQol) at baseline, 3, and 6 months post-randomisation 10. Healthcare resource use measured using a bespoke healthcare service use questionnaire (collecting participant’s use of primary, secondary, and community healthcare services, with special attention paid to physical activity and mental health related services) at baseline, 3, and 6 months post-randomisation |
| Overall study start date | 01/07/2022 |
| Completion date | 31/12/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 48-72 |
| Total final enrolment | 71 |
| Key inclusion criteria | 1. Aged ≥18 years 2. Schizophrenia and other non-organic psychoses (ICD F20 -F29 and subcodes or DSM equivalent), and Bipolar Disorder and manic episodes (ICD F30 and F31 and subcodes and DSM equivalent) 3. Able to walk unaided |
| Key exclusion criteria | 1. Lack capacity to participate 2. Primary diagnosis of drug or alcohol abuse 3. Have a medical contraindication of physical activity 4. Already physically active, defined as currently doing >300 min/week of self-reported moderate to vigorous physical activity 5. Unwilling to wear accelerometer 6. Non-English speakers |
| Date of first enrolment | 26/09/2022 |
| Date of final enrolment | 28/04/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Old Fulwood Road
Sheffield
S10 3TH
United Kingdom
Fieldhead Hospital
Ouchthorpe Lane
Wakefield
WF1 3SP
United Kingdom
Hermitage Lane
Maidstone
ME16 9PH
United Kingdom
C E M E Centre
Marsh Way
Rainham
RM13 8GQ
United Kingdom
Monks Orchard Road
Beckenham
BR3 3BX
United Kingdom
West Park Hospital
Edward Pease Way
Darlington
DL2 2TS
United Kingdom
Thorpe Park
Leeds
LS15 8ZB
United Kingdom
Sponsor information
Hospital/treatment centre
Fulwood House
Old Fulwood Road
Sheffield
S10 3TH
England
United Kingdom
| Phone | +44 (0)1142716605 |
|---|---|
| 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 | 29/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| 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 stored in a publicly available repository. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Protocol article | 17/02/2024 | 19/02/2024 | Yes | No |
Editorial Notes
24/05/2024: Total final enrolment added.
19/02/2024: Publication reference added.
16/05/2023: Contact details updated.
02/02/2023: The recruitment end date was changed from 28/02/2023 to 28/04/2023.
03/10/2022: Internal review.
12/09/2022: The recruitment start date has been changed from 01/09/2022 to 26/09/2022.
05/08/2022: Trial’s existence confirmed by the National Institute for Health and Care Research.
