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  • Gareth Jones
    Sheffield Hallam University
  • Laura Bailey
    Leeds University
  • Rebecca J Beeken
    University of Leeds
  • Samantha Brady
    University of York
  • Cindy Cooper
    University of Sheffield
  • Robert Copeland
    Sheffield Hallam University
  • Suzanne Crosland
    University of York
  • Sam Dawson
    Sheffield Health and Social Care NHS Foundation Trust
  • Matthew Faires
    University of York
  • Simon Gilbody
    University of York
  • Holly Haynes
    University of Sheffield
  • Andrew Hill
    University of Leeds
  • Emily Hillison
    Sheffield Health and Social Care NHS Foundation Trust
  • Michelle Horspool
    Sheffield Health and Social Care NHS Foundation Trust
  • Ellen Lee
    University of Sheffield
  • Jinshuo Li
    York University
  • Katarzyna Karolina Machaczek
    Sheffield Hallam University
  • Steve Parrott
    University of York
  • Helen Quirk
    University of Sheffield
  • Brendon Stubbs
    Kings College London
  • Garry A Tew
    York St. John
  • Gemma D Traviss-Turner
    University of Leeds
  • Emily Turton
    University of Sheffield
  • Lauren Walker
    City University of London
  • Stephen Walters
    University of Sheffield
  • Scott Weich
    University of Sheffield
  • Ellie Wildbore
    Sheffield Health and Social Care NHS Foundation Trust
  • Emily Peckham

BACKGROUND: Severe mental ill health (SMI) includes schizophrenia, bipolar disorder and schizoaffective disorder and is associated with premature deaths when compared to people without SMI. Over 70% of those deaths are attributed to preventable health conditions, which have the potential to be positively affected by the adoption of healthy behaviours, such as physical activity. People with SMI are generally less active than those without and face unique barriers to being physically active. Physical activity interventions for those with SMI demonstrate promise, however, there are important questions remaining about the potential feasibility and acceptability of a physical activity intervention embedded within existing NHS pathways.

METHOD: This is a two-arm multi-site randomised controlled feasibility trial, assessing the feasibility and acceptability of a co-produced physical activity intervention for a full-scale trial across geographically dispersed NHS mental health trusts in England. Participants will be randomly allocated via block, 1:1 randomisation, into either the intervention arm or the usual care arm. The usual care arm will continue to receive usual care throughout the trial, whilst the intervention arm will receive usual care plus the offer of a weekly, 18-week, physical activity intervention comprising walking and indoor activity sessions and community taster sessions. Another main component of the intervention includes one-to-one support. The primary outcome is to investigate the feasibility and acceptability of the intervention and to scale it up to a full-scale trial, using a short proforma provided to all intervention participants at follow-up, qualitative interviews with approximately 15 intervention participants and 5 interventions delivery staff, and data on intervention uptake, attendance, and attrition. Usual care data will also include recruitment and follow-up retention. Secondary outcome measures include physical activity and sedentary behaviours, body mass index, depression, anxiety, health-related quality of life, healthcare resource use, and adverse events. Outcome measures will be taken at baseline, three, and six-months post randomisation.

DISCUSSION: This study will determine if the physical activity intervention is feasible and acceptable to both participants receiving the intervention and NHS staff who deliver it. Results will inform the design of a larger randomised controlled trial assessing the clinical and cost effectiveness of the intervention.

TRIAL REGISTRATION: ISRCTN: ISRCTN83877229. Registered on 09.09.2022.

Keywords

  • Exercise, Severe mental illness, Health behaviour, pilot studies
Original languageEnglish
Article number32
JournalBMC Pilot and Feasibility Studies
Volume10
Issue number1
DOIs
Publication statusPublished - 17 Feb 2024

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