Supporting physical activity through co-production in people with severe mental ill health (SPACES): protocol for a randomised controlled feasibility trial.

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.

Effect of a cervical collar on head and neck acceleration profiles during emergency spinal immobilisation and extrication procedures in elite football (soccer) players: protocol for a randomised, controlled cross-over trial.

When immobilisation after a cervical spine or head injury is required, the role of the rigid cervical collar is unclear and controversial. There is a need for further studies investigating the use of a rigid cervical collar when head and neck trauma occurs in sport. This study will compare present practice (immobilisation with a cervical collar) to the same procedure without a collar during a simulated spinal immobilisation and extraction scenario from the field of play to the side-line in football (soccer). It will use a prospective cohort within-subjects cross over randomised, controlled trial design. Healthy participants will assume the role of players with a head or neck injury. Clinical practitioners will perform the immobilisation and extrication procedure according to current clinical guidelines. Three dimensional linear and angular acceleration profiles of the head and torso will be measured and the time taken to complete the procedure. The interventions will be a 'cervical collar' or 'no collar' in random order. Data from the IMUs will be transferred wirelessly to a computer for analysis. Accordingly, within-subject differences between each condition (collar vs no collar) will be assessed with parametric or non-parametric inferential statistics. Statistical significance will be set at p<0.05. Trial registration number: ISRCTN16515969.