Munro Julie, Goodman William, Oliphant Raymond, Russell Sarah, Taylor Claire, Beeken Rebecca J, Hubbard Gill
Department of Nursing & Midwifery, Centre for Health Sciences, University of the Highlands and Islands, Inverness, UK.
Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.
Pilot Feasibility Stud. 2023 Jul 3;9(1):111. doi: 10.1186/s40814-023-01329-8.
Parastomal bulging/hernia is a common complication associated with a stoma. Strengthening of the abdominal muscles via exercise may be a useful self-management strategy. The aim of this feasibility work was to address uncertainties around testing a Pilates-based exercise intervention for people with parastomal bulging.
An exercise intervention was developed and tested in a single-arm trial (n = 17 recruited via social media) followed by a feasibility randomised controlled trial RCT (n = 19 recruited from hospitals). Adults with an ileostomy or colostomy with a bulge or diagnosed hernia around their stoma were eligible. The intervention involved a booklet, videos, and up to 12 online sessions with an exercise specialist. Feasibility outcomes included intervention acceptability, fidelity, adherence, and retention. Acceptability of self-report measures for quality of life, self-efficacy, and physical activity were assessed based on missing data within surveys pre- and post-intervention. Interviews (n = 12) explored participants' qualitative experiences of the intervention.
Nineteen of 28 participants referred to the intervention completed the programme (67%) and received an average of 8 sessions, lasting a mean of 48 min. Sixteen participants completed follow-up measures (44% retention), with low levels of missing data across the different measures, apart from body image and work/social function quality of life subscales (50% and 56% missing, respectively). Themes from qualitative interviews related to the benefits of being involved, including behavioural and physical changes in addition to improved mental health. Identified barriers included time constraints and health issues.
The exercise intervention was feasible to deliver, acceptable to participants, and potentially helpful. Qualitative data suggests physical and psycholosical benefits. Strategies to improve retention need to be included in a future study.
ISRCTN, ISRCTN15207595 . Registered on 11 July 2019.
造口旁膨出/疝是与造口相关的常见并发症。通过锻炼增强腹部肌肉可能是一种有用的自我管理策略。这项可行性研究的目的是解决围绕为造口旁膨出患者测试基于普拉提的运动干预措施的不确定性。
开发了一种运动干预措施，并在一项单臂试验（通过社交媒体招募了17名参与者）中进行测试，随后进行了一项可行性随机对照试验（RCT，从医院招募了19名参与者）。有回肠造口术或结肠造口术且造口周围有膨出或诊断为疝的成年人符合条件。干预措施包括一本手册、视频以及与一名运动专家进行的多达12次在线课程。可行性结果包括干预措施的可接受性、保真度、依从性和保留率。基于干预前后调查中的缺失数据，评估了生活质量、自我效能感和身体活动的自我报告测量方法的可接受性。访谈（n = 12）探讨了参与者对干预措施的定性体验。
28名被转介参与干预的参与者中有19名完成了该计划（67%），平均接受了8次课程，每次课程平均持续48分钟。16名参与者完成了随访测量（保留率为44%），除身体形象和工作/社会功能生活质量子量表外（分别缺失50%和56%），不同测量方法中的缺失数据水平较低。定性访谈的主题涉及参与的益处，包括行为和身体变化以及心理健康改善。确定的障碍包括时间限制和健康问题。
运动干预措施实施可行，参与者可接受，且可能有帮助。定性数据表明有身体和心理益处。未来的研究需要纳入提高保留率的策略。
ISRCTN，ISRCTN15207595。于2019年7月11日注册。
