目的:英国的国家指南建议腿部静脉性溃疡患者有规律的运动。然而,关于运动对溃疡愈合和复发的影响的数据很少。在本研究中,我们的目的是量化关于静脉性溃疡愈合的运动证据,包括溃疡愈合比例和溃疡复发率的主要结局.次要结果是溃疡症状的改善,溃疡愈合时间,生活质量,合规,和报告的不良事件。
方法:审查遵循PRISMA(系统审查和荟萃分析的首选报告项目)指南,使用注册方案(CRD42021220925)。MEDLINE和Embase数据库以及Cochrane中央对照试验登记册,ClinicalTrials.gov,欧盟临床试验,截至2022年4月6日,我们搜索了国际标准随机对照试验编号登记册,纳入了比较运动疗法和压缩疗法与单纯压缩疗法的研究.使用固定效应荟萃分析汇总溃疡愈合比例的数据。
结果:筛选1046份报告后,包括7个,121名参与者被分配进行运动治疗,125名参与者被分配进行单独的压缩治疗。所有报告均为随机对照试验,并在12周报告溃疡愈合,运动与压缩的溃疡愈合的总相对风险为1.38(95%置信区间,1.11-1.71).只有一项研究报告了复发;因此,未进行数据合并.运动和常规护理之间没有差异。锻炼依从性从33%到81%不等。纳入的研究表明,低入学率和高偏倚风险。此外,大多数试验未能证明干预组和控制组之间完成的活动有任何差异.
结论:很少有研究检查了运动计划后腿部溃疡的复发,没有证据表明锻炼是有益的。此外,支持运动作为溃疡愈合辅助手段的证据质量非常低,试验证明了严重的方法学缺陷,主要记录干预部门参与者进行的活动。未来的随机对照试验应实施活动监测,规范重点患者的报告,溃疡,和反流特征,以便将来进行有意义的荟萃分析,以确定运动作为静脉腿部溃疡愈合的辅助作用。
National guidelines in the United Kingdom have recommended regular exercise for individuals with venous leg ulceration. However, data on the effects of exercise on ulcer healing and recurrence are sparse. In the present study, we aimed to quantify the evidence for exercise regarding venous ulcer healing with respect to the primary outcomes of the proportion of healed ulcers and rate of ulcer recurrence. The secondary outcomes were improvement in ulcer symptoms, ulcer healing time, quality of life, compliance, and adverse events reported.
The review followed PRISMA (preferred reporting items for systematic reviews and meta-analyses) guidelines using a registered protocol (CRD42021220925). The MEDLINE and Embase databases and Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, European Union Clinical Trials, and International Standard Randomised Controlled Trial Number registries were searched up to April 6, 2022 and included studies comparing exercise therapy and compression vs compression alone. Data for the proportion of healed ulcers were pooled using a fixed effects meta-analysis.
After screening 1046 reports, 7 were included, with 121 participants allocated to exercise therapy and 125 to compression alone. All the reports were of randomized controlled trials and had reported ulcer healing at 12 weeks, with a pooled relative risk of ulcer healing of 1.38 for exercise vs compression (95% confidence interval, 1.11-1.71). Only one study had reported on recurrence; thus, data pooling was not performed. No differences between exercise and usual care were demonstrated. Compliance with exercise ranged from 33% to 81%. The included studies demonstrated low enrollment and a high risk of bias. Also, most of the trials had failed to demonstrate any differences in activity completed between the intervention and control arms.
A paucity of studies has examined leg ulcer recurrence after exercise programs, with no evidence to show that exercise is beneficial. Furthermore, the quality of evidence supporting exercise as an adjunct to ulcer healing is very low, and the trials demonstrated serious methodologic flaws, chiefly in recording the activity undertaken by the participants in the intervention arm. Future randomized controlled trials should implement activity monitoring and standardize the reporting of key patient, ulcer, and reflux characteristics to enable future meaningful meta-analyses to determine the role of exercise as an adjunct to venous leg ulceration healing.