Bourne Jessica E, Leary Sam, Page Angie, Searle Aidan, England Clare, Thompson Dylan, Andrews Robert C, Foster Charlie, Cooper Ashley R
Centre for Exercise, Nutrition and Health Sciences, School of Policy Studies, University of Bristol, 8 Priory Road, Bristol, BS8 1TZ, UK.
NIHR Bristol Biomedical Research Centre, University Hospitals Bristol and Weston NHS Foundation Trust and University of Bristol, Bristol, UK.
Pilot Feasibility Stud. 2023 Apr 18;9(1):60. doi: 10.1186/s40814-023-01283-5.
Type 2 diabetes mellitus (T2DM) and its associated complications puts considerable strain on healthcare systems. With the global incidence of T2DM increasing, effective disease management is essential. Physical activity (PA) is a key component of T2DM management; however, rates of PA engagement are low in this population. Developing effective and sustainable interventions that encourage PA is a high priority. Electrically assisted bicycles are becoming increasingly popular and may increase PA in healthy adults. This study aimed to provide evidence of the feasibility of conducting a randomized controlled trial to evaluate the efficacy of an e-cycling intervention to increase PA and improve health in individuals with T2DM.
A parallel-group two-arm randomized, waitlist-controlled pilot study was conducted. Individuals were randomized to either an e-bike intervention or standard care. The intervention incorporated two one-to-one e-bike skills training and behavioural counselling sessions delivered by a community-based cycling charity, followed by a 12-week e-bike loan with two further sessions with the instructors. Feasibility was assessed via measures related to recruitment, retention and intervention implementation. Post-intervention interviews with instructors and participants explored the acceptability of the study procedures and intervention. Clinical, physiological and behavioural outcomes were collected at baseline and post-intervention to evaluate the intervention's potential.
Forty participants (M = 57) were randomized, of which 34 were recruited from primary care practices. Thirty-five participants were retained in the trial. The intervention was conducted with high fidelity (> 80% content delivered). E-bike training provided participants with the skills, knowledge and confidence needed to e-bike independently. Instructors reported being more confident delivering the skills training than behavioural counselling, despite acknowledging its importance. The study procedures were found to be acceptable to participants. Between-group differences in change during the intervention were indicative of the interventions potential for improving glucose control, health-related quality of life and cardiorespiratory fitness. Increases in overall device measured moderate-to-vigorous PA behaviour following the intervention were found, and there was evidence that this population self-selected to e-cycle at a moderate intensity.
The study's recruitment, retention, acceptability and potential efficacy support the development of a definitive trial subject to identified refinements.
ISRCTN, ISRCTN67421464 . Registered 17/12/2018.
2型糖尿病（T2DM）及其相关并发症给医疗系统带来了相当大的压力。随着全球T2DM发病率的上升，有效的疾病管理至关重要。体育活动（PA）是T2DM管理的关键组成部分；然而，该人群的PA参与率较低。开发鼓励PA的有效且可持续的干预措施是当务之急。电动助力自行车越来越受欢迎，可能会增加健康成年人的PA。本研究旨在为开展一项随机对照试验提供可行性证据，以评估电动自行车骑行干预对增加T2DM患者的PA和改善健康状况的疗效。
进行了一项平行组双臂随机、等待名单对照的试点研究。个体被随机分为电动自行车干预组或标准护理组。干预包括由一个社区自行车慈善机构提供的两次一对一电动自行车技能培训和行为咨询课程，随后是为期12周的电动自行车借用，并与指导教师再进行两次课程。通过与招募、保留和干预实施相关的指标评估可行性。干预后对指导教师和参与者进行访谈，探讨研究程序和干预的可接受性。在基线和干预后收集临床、生理和行为结果，以评估干预的潜力。
40名参与者（平均年龄57岁）被随机分组，其中34名从初级保健机构招募。35名参与者留在试验中。干预以高保真度进行（超过80%的内容得以实施）。电动自行车培训为参与者提供了独立骑电动自行车所需的技能、知识和信心。指导教师报告说，尽管认识到行为咨询的重要性，但在提供技能培训方面比行为咨询更有信心。研究程序被参与者认为是可以接受的。干预期间组间变化差异表明干预在改善血糖控制、健康相关生活质量和心肺适能方面具有潜力。干预后发现总体设备测量的中度至剧烈PA行为有所增加，并且有证据表明该人群自我选择以中等强度骑电动自行车。
该研究的招募、保留、可接受性和潜在疗效支持在确定改进措施后开展一项确定性试验。
ISRCTN，ISRCTN67421464。2018年12月17日注册。
