Diabetes Research Centre, University of Leicester, Leicester, UK
NIHR Leicester Biomedical Research Centre, University of Leicester, Leicester, UK.
BMJ Open. 2020 Jun 21;10(6):e039062. doi: 10.1136/bmjopen-2020-039062.
Once diagnosed with a diabetic foot ulcer (DFU), patients are advised to offload, keeping pressure off the foot in order to facilitate ulcer healing. An increase in offloading is often accompanied by reductions in physical activity which can worsen the overall health of patients.While unable to perform traditional forms of upright activity, one mode of exercise that would allow patients to be physically active while adhering to offloading instruction is seated arm ergometry. The merits of tailored aerobic exercise in DFU remain unexplored.
This is a prospective open-label randomised controlled trial. Participants will be randomised to one of two groups, an exercise intervention group or control. The intervention group are required to undertake arm ergometry training at a moderate intensity (65%-75% HRpeak), three times per week for 12 weeks as individually prescribed by an exercise physiologist, while the control group will continue to receive standard care alone. Assessment of outcome measures will occur at baseline and after the intervention period, these will include: a seated VO peak test, a blood sample, a short physical performance battery, a dual-energy X-ray absorptiometry scan and completing a range of health-based questionnaires. The above will be used to determine: cardiorespiratory fitness, metabolic health, physical function, body composition and quality of life, respectively. Ulcer area will also be measured as an approximate marker of ulcer healing.
This trial has been approved by 'Yorkshire & The Humber-Leeds West Research Ethics Committee' (19/YH/0269). Trial results will be published in peer-reviewed journals and through conference presentations.
ISRCTN16000053. Registered in accordance with WHO Trial Registration Data Set (version 1.3.1).
一旦被诊断出患有糖尿病足溃疡（DFU），患者就需要进行减压治疗，以避免足部受压，从而促进溃疡愈合。增加减压通常伴随着体力活动的减少，这可能会使患者的整体健康状况恶化。虽然患者无法进行传统形式的直立活动，但有一种运动方式可以让他们在遵守减压医嘱的同时保持身体活跃，那就是坐姿手臂测功计运动。针对 DFU 量身定制的有氧锻炼的优点仍有待探索。
这是一项前瞻性开放标签随机对照试验。参与者将被随机分配到两个组之一，即运动干预组或对照组。干预组需要按照运动生理学家的个人处方，以中等强度（65%-75% HRpeak）每周进行三次手臂测功计训练，共 12 周，而对照组将继续单独接受标准护理。在基线和干预期结束时将评估结果测量指标，包括：坐姿 VO 峰值测试、血液样本、短体物理性能测试、双能 X 射线吸收仪扫描和完成一系列健康问卷。以上将用于分别确定：心肺适能、代谢健康、身体功能、身体成分和生活质量。溃疡面积也将作为溃疡愈合的近似标志物进行测量。
该试验已获得“约克郡和亨伯-利兹西部研究伦理委员会”（19/YH/0269）的批准。试验结果将发表在同行评议的期刊上，并通过会议演讲传播。
ISRCTN86202766。根据世界卫生组织试验注册数据集（版本 1.3.1）进行注册。
