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Supporting Physical Activity through Co-production in people with Severe Mental Illness (SPACES): a pragmatic randomised controlled trial

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN23019026
Enrollment
736
Registered
2024-08-07
Start date
2024-09-01
Completion date
Unknown
Last updated
2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Increase in physical activity in people with severe mental illness Mental and Behavioural Disorders

Interventions

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 w

Sponsors

Sheffield Health and Social Care NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Objective accelerometer-derived minutes per day of Moderate to Vigorous Physical Activity (MVPA) measured at 6-months post randomisation

Secondary

MeasureTime frame
Current secondary outcomes as of 29/05/2026: 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. Body mass index (kg/m²) 4. Depression (PHQ-9) 5. Anxiety (GAD-7) 6. Loneliness (UCLA-3 item) 7. Health-related quality of life (EQ5D, REQoL) 8. Healthcare resource use and predictive behavioural questionnaire Health risk behaviours (smoking and diet) will be collected at baseline Previous secondary outcomes: 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

Countries

England, United Kingdom

Contacts

Public ContactEmily Peckham
e.peckham@bangor.ac.uk+44 3000 847 086

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jun 11, 2026