Jones Gareth, Bailey Laura, Beeken Rebecca J, Brady Samantha, Cooper Cindy, Copeland Robert J, Crosland Suzanne, Dawson Sam, Faires Matthew, Gilbody Simon, Haynes Holly, Hill Andrew, Hillison Emily, Horspool Michelle, Lee Ellen, Li Jinshuo, Machaczek Katarzyna K, Parrott Steve, Quirk Helen, Stubbs Brendon, Tew Garry A, Traviss-Turner Gemma, Turton Emily, Walker Lauren, Walters Stephen, Weich Scott, Wildbore Ellie, Peckham Emily
Advanced Wellbeing Research Centre, Sheffield Hallam University, Sheffield, S9 3TU, UK.
Sport and Physical Activity Research Centre, Health and Wellbeing Department, Sheffield Hallam University, Sheffield, UK.
Pilot Feasibility Stud. 2024 Feb 17;10(1):32. doi: 10.1186/s40814-024-01460-0.
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.
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.
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.
ISRCTN: ISRCTN83877229. Registered on 09.09.2022.
严重精神疾病（SMI）包括精神分裂症、双相情感障碍和分裂情感性障碍，与无严重精神疾病的人相比，其与过早死亡相关。超过70%的此类死亡归因于可预防的健康状况，而采取健康行为（如体育活动）有可能对这些状况产生积极影响。患有严重精神疾病的人通常比没有的人活动量少，并且在进行体育活动时面临独特的障碍。针对患有严重精神疾病者的体育活动干预显示出前景，然而，对于纳入现有国民保健服务（NHS）途径中的体育活动干预的潜在可行性和可接受性，仍存在重要问题。
这是一项双臂多中心随机对照可行性试验，评估共同制定的体育活动干预措施在英格兰各地分散的国民保健服务心理健康信托机构进行全面试验的可行性和可接受性。参与者将通过区组随机化以1:1的比例随机分配到干预组或常规护理组。常规护理组在整个试验期间将继续接受常规护理，而干预组将接受常规护理并获得一项为期18周的每周体育活动干预，包括步行和室内活动课程以及社区体验课程。干预的另一个主要组成部分包括一对一支持。主要结果是使用随访时提供给所有干预参与者的简短表格、对约15名干预参与者和5名干预实施人员进行定性访谈以及关于干预接受情况、出勤情况和损耗的数据，调查干预措施的可行性和可接受性，并将其扩大到全面试验。常规护理数据还将包括招募和随访留存情况。次要结果指标包括体育活动和久坐行为、体重指数、抑郁、焦虑、健康相关生活质量、医疗资源使用情况和不良事件。结果指标将在随机分组后的基线、三个月和六个月时进行测量。
本研究将确定体育活动干预措施对于接受干预的参与者和实施干预的国民保健服务工作人员而言是否可行和可接受。研究结果将为评估该干预措施临床和成本效益的更大规模随机对照试验的设计提供信息。
国际标准随机对照试验编号（ISRCTN）：ISRCTN83877229。于2022年9月9日注册。
