一项旨在改善造口患者生活质量的体育活动干预措施：可行性研究方案。
A physical activity intervention to improve the quality of life of patients with a stoma: a feasibility study protocol.
作者信息
Hubbard Gill, Beeken Rebecca J, Taylor Claire, Watson Angus J M, Munro Julie, Goodman William
机构信息
1Department of Nursing and Midwifery, University of the Highlands and Islands, Centre for Health Science, Old Perth Road, Inverness, IV2 3JH Scotland, UK.
2Leeds Institute of Health Sciences, University of Leeds, Worsley Building, Clarendon Way, Leeds, LS2 9NL England, UK.
出版信息
Pilot Feasibility Stud. 2019 Jun 17;5:78. doi: 10.1186/s40814-019-0461-2. eCollection 2019.
BACKGROUND
Physical activity (PA) is positively associated with quality of life. People with a stoma are less likely to engage in PA than those without a stoma.
METHODS
In this feasibility intervention study, we will perform the following: (1) Develop a PA intervention for people with a stoma. An Expert Working Group of behavioural scientists, exercise scientists, clinicians and a Patient Advisory Group of people with a bowel stoma will meet with the research team to inform the development of a PA intervention for people with a stoma. A manual of the intervention will be the main output. (2) Explore PA instructors' experiences of delivering the PA intervention. PA instructors will record on paper the number of PA consultations with each patient and a researcher will interview the PA instructors about their experiences of delivering the intervention. (3) Assess the level of patient (bowel cancer or inflammatory bowel disease (IBD) patients with a stoma between 6 weeks and 24 months post-surgery) engagement with the PA intervention and their views on intervention acceptability and usefulness. Patients will keep a PA diary to record daily pedometer recorded step count and type and duration of activities. A researcher will interview patients about their experiences of the PA intervention. (4) Assess screening, eligibility, consent, data completion, loss to follow up, and missing data rates, representativeness of participants and potential treatment effects. A researcher will record on paper all study procedure parameters. Quality of life (stoma-quality of life; Functional Assessment of Cancer Therapy, Short IBD questionnaire), fatigue (FACIT fatigue scale) and PA (accelerometer) will be measured pre- and post-intervention in patients. For IBD patients only, blood will be taken to measure systemic inflammation.
DISCUSSION
We hypothesise that a PA intervention will be an effective means of improving the quality of life of people with a stoma. Before embarking on a full randomised controlled trial to test this hypothesis, a PA intervention needs to be developed and a feasibility study of the proposed PA intervention conducted.
TRIAL REGISTRATION
ISRCTN58613962, Protocol version: 0.1. 14 September 2017.
背景
身体活动（PA）与生活质量呈正相关。有造口的人比没有造口的人参与身体活动的可能性更低。
方法
在这项可行性干预研究中，我们将开展以下工作：（1）为有造口的人制定身体活动干预方案。行为科学家、运动科学家、临床医生组成的专家工作小组以及肠造口患者组成的患者咨询小组将与研究团队会面，为制定针对有造口者的身体活动干预方案提供信息。干预手册将作为主要成果。（2）探究健身教练实施身体活动干预的经验。健身教练将用纸记录与每位患者进行身体活动咨询的次数，研究人员将就健身教练实施干预的经验对其进行访谈。（3）评估患者（术后6周和24个月之间的患有造口的结肠癌或炎症性肠病（IBD）患者）对身体活动干预的参与程度以及他们对干预可接受性和有用性的看法。患者将记录身体活动日记，以记录每日计步器记录的步数以及活动类型和时长。研究人员将就患者对身体活动干预的体验对其进行访谈。（4）评估筛查、合格性、同意情况、数据完整性、失访情况以及缺失数据率、参与者的代表性和潜在治疗效果。研究人员将用纸记录所有研究程序参数。将在干预前后对患者测量生活质量（造口生活质量；癌症治疗功能评估、IBD简短问卷）、疲劳（FACIT疲劳量表）和身体活动（加速度计）。仅针对IBD患者，将采集血液以测量全身炎症。
讨论
我们假设身体活动干预将是改善有造口者生活质量的有效手段。在开展全面随机对照试验以检验这一假设之前，需要制定身体活动干预方案并对拟议的身体活动干预进行可行性研究。
试验注册
ISRCTN58613962，方案版本：0.1。2017年9月14日。
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