Tew Garry A, Michaels Jonathan, Crank Helen, Middleton Geoff, Gumber Anil, Klonizakis Markos
York Trials Unit, Department of Health Sciences, University of York, Heslington, York, YO10 5DD, UK.
Health Economics and Decision Science, ScHARR, University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, UK.
Trials. 2015 Oct 6;16:443. doi: 10.1186/s13063-015-0963-z.
Venous leg ulcers are common, chronic wounds that are painful and reduce quality of life. Compression therapy is known to assist in the healing of venous leg ulceration. Supervised exercise training that targets an improvement in calf muscle pump function might be a useful adjunctive therapy for enhancing ulcer healing and other aspects of physical and mental health. However, the evidence of exercise for individuals with venous ulcers is sparse. Here, we describe the protocol for a study that aims to assess the feasibility of undertaking a randomised controlled trial of a supervised exercise programme in people who are receiving compression for venous ulceration.
METHODS/DESIGN: This is a randomised, controlled, assessor-blinded, two-centre, feasibility trial with two parallel groups. Eighty adults who are receiving lower-limb compression for a venous leg ulcer will be randomly assigned to receive usual care (compression only) or usual care plus a 12-week supervised exercise programme. Participants in the exercise group will be invited to undertake three, 60-minute sessions of supervised exercise each week, and each session will involve a combination of treadmill walking, upright cycling and strength and flexibility exercises for the lower limbs. Participants will be assessed before randomisation and 3, 6 and 12 months after randomisation. Primary outcomes include rates of recruitment, retention and adherence. Secondary outcomes include time to ulcer healing, proportion of participants healed, percentage and absolute change in ulcer size, health-related quality of life (EQ-5D-5L and VEINES-QOL/Sym), lower-limb cutaneous microvascular function (laser Doppler flowmetry coupled with iontophoresis) and physical fitness (30-second sit-to-stand test, chair sit and reach test, 6-minute walk test and ankle range of motion). The costs associated with the exercise programme and health-care utilisation will be calculated. We will also complete interviews with a sub-sample of participants to explore their experiences of having a venous ulcer and the acceptability of the exercise intervention and study procedures.
Data from this study will be used to refine the supervised exercise programme, investigate the acceptability of the intervention and study design and determine the most appropriate outcome measures, thereby providing estimates of the factors needed to design an adequately powered trial across several centres.
Current Controlled Trials, ISRCTN10205425 (May 2014) - http://www.controlled-trials.com/ISRCTN10205425.
下肢静脉溃疡是常见的慢性伤口，会引起疼痛并降低生活质量。已知压迫疗法有助于下肢静脉溃疡的愈合。旨在改善小腿肌肉泵功能的监督式运动训练可能是促进溃疡愈合以及改善身心健康其他方面的一种有用的辅助疗法。然而，针对患有静脉溃疡的个体进行运动的证据并不充分。在此，我们描述一项研究的方案，该研究旨在评估对接受下肢静脉溃疡压迫治疗的患者进行监督式运动计划的随机对照试验的可行性。
方法/设计：这是一项随机、对照、评估者盲法、双中心的可行性试验，设有两个平行组。80名因下肢静脉溃疡而接受下肢压迫治疗的成年人将被随机分配接受常规护理（仅压迫治疗）或常规护理加为期12周的监督式运动计划。运动组的参与者将被邀请每周参加三次、每次60分钟的监督式运动，每次运动将包括跑步机行走、直立式骑行以及下肢的力量和柔韧性练习。参与者将在随机分组前以及随机分组后3个月、6个月和12个月接受评估。主要结局包括招募率、留存率和依从性。次要结局包括溃疡愈合时间、愈合的参与者比例、溃疡大小的百分比及绝对变化、健康相关生活质量（EQ-5D-5L和VEINES-QOL/Sym）、下肢皮肤微血管功能（激光多普勒血流仪结合离子导入法）以及身体素质（30秒坐立试验、椅子坐位体前屈试验、6分钟步行试验和踝关节活动范围）。将计算与运动计划和医疗保健利用相关联的成本。我们还将对一部分参与者进行访谈，以探究他们患静脉溃疡的经历以及运动干预和研究程序的可接受性。
本研究的数据将用于完善监督式运动计划，调查干预措施和研究设计的可接受性，并确定最合适的结局指标，从而为设计一项在多个中心进行的有足够效力的试验所需的因素提供评估。
当前受控试验，ISRCTN注册号为10205425（2014年5月） - http://www.controlled-trials.com/ISRCTN10205425 。
