Research Institute for Sport and Exercise Science, Liverpool John Moores University, Liverpool, UK.
School of Health and Exercise Sciences, University of British Columbia, Kelowna, British Columbia, Canada.
BMJ Open. 2021 Nov 26;11(11):e052563. doi: 10.1136/bmjopen-2021-052563.
Exercise and physical activity (PA) are fundamental to the treatment of type 2 diabetes. Current exercise and PA strategies for newly diagnosed individuals with type 2 diabetes are either clinically effective but unsuitable in routine practice (supervised exercise) or suitable in routine practice but clinically ineffective (PA advice). Mobile health (mHealth) technologies, offering biometric data to patients and healthcare professionals, may bridge the gap between supervised exercise and PA advice, enabling patients to engage in regular long-term physically active lifestyles. This feasibility randomised controlled trial (RCT) will evaluate the use of mHealth technology when incorporated into a structured home-based exercise and PA intervention, in those recently diagnosed with type 2 diabetes.
This feasibility multicentre, parallel group RCT will recruit 120 individuals with type 2 diabetes (diagnosis within 5-24 months, aged 40-75 years) in the UK (n=60) and Canada (n=60). Participants will undertake a 6-month structured exercise and PA intervention and be supported by an exercise specialist (active control). The intervention group will receive additional support from a smartwatch and phone app, providing real-time feedback and enabling improved communication between the exercise specialist and participant. Primary outcomes are recruitment rate, adherence to exercise and loss to follow-up. Secondary outcomes include a qualitative process evaluation and piloting of potential clinical outcome measures for a future RCT.
The trial was approved in the UK by the South East Scotland Research Ethics Committee 01 (20/SS/0101) and in Canada by the Clinical Research Ethics Board of the University of British Columbia (H20-01936), and is being conducted in accordance with the Declaration of Helsinki and Good Clinical Practice. Results will be published in peer-reviewed journals and presented at national and international scientific meetings.
ISRCTN14335124; ClinicalTrials.gov: NCT04653532.
运动和身体活动（PA）是 2 型糖尿病治疗的基础。目前针对新诊断的 2 型糖尿病患者的运动和 PA 策略，要么是临床有效但不适合常规实践（监督运动），要么是适合常规实践但临床无效（PA 建议）。移动健康（mHealth）技术为患者和医疗保健专业人员提供生物计量数据，可能会弥合监督运动和 PA 建议之间的差距，使患者能够养成定期的长期积极生活方式。这项可行性随机对照试验（RCT）将评估将 mHealth 技术纳入基于家庭的结构化运动和 PA 干预措施时，对最近被诊断为 2 型糖尿病的患者的使用情况。
这项可行性多中心、平行组 RCT 将在英国（n=60）和加拿大（n=60）招募 120 名 2 型糖尿病患者（诊断时间在 5-24 个月内，年龄 40-75 岁）。参与者将进行为期 6 个月的结构化运动和 PA 干预，并由运动专家（积极对照组）提供支持。干预组将通过智能手表和手机应用获得额外支持，提供实时反馈，并改善运动专家和参与者之间的沟通。主要结果是招募率、对运动的依从性和随访丢失率。次要结果包括定性过程评估和为未来 RCT 试点潜在临床结果测量。
该试验在英国获得了东南苏格兰研究伦理委员会 01 号（20/SS/0101）的批准，在加拿大获得了不列颠哥伦比亚大学临床研究伦理委员会（H20-01936）的批准，并且正在按照《赫尔辛基宣言》和良好临床实践进行。结果将发表在同行评议的期刊上，并在国家和国际科学会议上进行报告。
ISRCTN85132617；ClinicalTrials.gov：NCT04653532。
