Jansen Sandra Cp, Abaraogu Ukachukwu Okoroafor, Lauret Gert Jan, Fakhry Farzin, Fokkenrood Hugo Jp, Teijink Joep Aw
Department of Vascular Surgery, Catharina Hospital, Eindhoven, Netherlands.
CAPHRI School for Public Health and Primary Care, Maastricht University Medical Centre, Maastricht, Netherlands.
Cochrane Database Syst Rev. 2020 Aug 20;8(8):CD009638. doi: 10.1002/14651858.CD009638.pub3.
According to international guidelines and literature, all patients with intermittent claudication should receive an initial treatment of cardiovascular risk modification, lifestyle coaching, and supervised exercise therapy. In the literature, supervised exercise therapy often consists of treadmill or track walking. However, alternative modes of exercise therapy have been described and yielded similar results to walking. This raises the following question: which exercise mode produces the most favourable results? This is the first update of the original review published in 2014.
To assess the effects of alternative modes of supervised exercise therapy compared to traditional walking exercise in patients with intermittent claudication.
The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase and CINAHL databases and World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 4 March 2019. We also undertook reference checking, citation searching and contact with study authors to identify additional studies. No language restriction was applied.
We included parallel-group randomised controlled trials comparing alternative modes of exercise training or combinations of exercise modes with a control group of supervised walking exercise in patients with clinically determined intermittent claudication. The supervised walking programme needed to be supervised at least twice a week for a consecutive six weeks of training.
Two review authors independently selected studies, extracted data, and assessed the risk of bias for each study. As we included studies with different treadmill test protocols and different measuring units (metres, minutes, or seconds), the standardised mean difference (SMD) approach was used for summary statistics of mean walking distance (MWD) and pain-free walking distance (PFWD). Summary estimates were obtained for all outcome measures using a random-effects model. We used the GRADE approach to assess the certainty of the evidence.
For this update, five additional studies were included, making a total of 10 studies that randomised a total of 527 participants with intermittent claudication (IC). The alternative modes of exercise therapy included cycling, lower-extremity resistance training, upper-arm ergometry, Nordic walking, and combinations of exercise modes. Besides randomised controlled trials, two quasi-randomised trials were included. Overall risk of bias in included studies varied from high to low. According to GRADE criteria, the certainty of the evidence was downgraded to low, due to the relatively small sample sizes, clinical inconsistency, and inclusion of three studies with risk of bias concerns. Overall, comparing alternative exercise modes versus walking showed no clear differences for MWD at 12 weeks (standardised mean difference (SMD) -0.01, 95% confidence interval (CI) -0.29 to 0.27; P = 0.95; 6 studies; 274 participants; low-certainty evidence); or at the end of training (SMD -0.11, 95% CI -0.33 to 0.11; P = 0.32; 9 studies; 412 participants; low-certainty evidence). Similarly, no clear differences were detected in PFWD at 12 weeks (SMD -0.01, 95% CI -0.26 to 0.25; P = 0.97; 5 studies; 249 participants; low-certainty evidence); or at the end of training (SMD -0.06, 95% CI -0.30 to 0.17; P = 0.59; 8 studies, 382 participants; low-certainty evidence). Four studies reported on health-related quality of life (HR-QoL) and three studies reported on functional impairment. As the studies used different measurements, meta-analysis was only possible for the walking impairment questionnaire (WIQ) distance score, which demonstrated little or no difference between groups (MD -5.52, 95% CI -17.41 to 6.36; P = 0.36; 2 studies; 96 participants; low-certainty evidence).
AUTHORS' CONCLUSIONS: This review found no clear difference between alternative exercise modes and supervised walking exercise in improving the maximum and pain-free walking distance in patients with intermittent claudication. The certainty of this evidence was judged to be low, due to clinical inconsistency, small sample size and risk of bias concerns. The findings of this review indicate that alternative exercise modes may be useful when supervised walking exercise is not an option. More RCTs with adequate methodological quality and sufficient power are needed to provide solid evidence for comparisons between each alternative exercise mode and the current standard of supervised treadmill walking. Future RCTs should investigate outcome measures on walking behaviour, physical activity, cardiovascular risk, and HR-QoL, using standardised testing methods and reporting of outcomes to allow meaningful comparison across studies.
根据国际指南和文献,所有间歇性跛行患者均应接受心血管风险修正、生活方式指导及监督下运动疗法的初始治疗。文献中,监督下运动疗法通常包括跑步机行走或在跑道上行走。然而,也有其他运动疗法模式被描述,且产生了与行走相似的效果。这就引出了以下问题:哪种运动模式能产生最有利的结果?这是对2014年发表的原始综述的首次更新。
评估与传统步行运动相比,替代模式的监督下运动疗法对间歇性跛行患者的影响。
Cochrane血管信息专家检索了Cochrane血管专业注册库、CENTRAL、MEDLINE、Embase和CINAHL数据库以及世界卫生组织国际临床试验注册平台和ClinicalTrials.gov试验注册库,检索截至2019年3月4日。我们还进行了参考文献核对、引文检索并与研究作者联系以识别其他研究。未设语言限制。
我们纳入了平行组随机对照试验,比较运动训练的替代模式或运动模式组合与临床确诊的间歇性跛行患者的监督下步行运动对照组。监督下步行计划需要每周至少监督两次,连续训练六周。
两位综述作者独立选择研究、提取数据并评估每项研究的偏倚风险。由于我们纳入了具有不同跑步机测试方案和不同测量单位(米、分钟或秒)的研究,因此采用标准化均数差(SMD)方法对平均步行距离(MWD)和无痛步行距离(PFWD)进行汇总统计。使用随机效应模型获得所有结局指标的汇总估计值。我们采用GRADE方法评估证据的确定性。
本次更新纳入了另外五项研究,共10项研究,随机分配了总共527例间歇性跛行(IC)患者。运动疗法的替代模式包括骑自行车、下肢阻力训练、上臂测力计训练、越野行走以及运动模式组合。除了随机对照试验,还纳入了两项半随机试验。纳入研究的总体偏倚风险从高到低不等。根据GRADE标准,由于样本量相对较小、临床不一致性以及纳入了三项存在偏倚风险的研究,证据的确定性被降至低等。总体而言,比较替代运动模式与步行,在12周时MWD无明显差异(标准化均数差(SMD)-0.01,95%置信区间(CI)-0.29至0.27;P = 0.95;6项研究;274名参与者;低确定性证据);或在训练结束时(SMD -0.11,95% CI -0.33至0.11;P = 0.32;9项研究;412名参与者;低确定性证据)。同样,在12周时PFWD也未检测到明显差异(SMD -0.01,95% CI -0.26至0.25;P = 0.97;5项研究;249名参与者;低确定性证据);或在训练结束时(SMD -0.06,95% CI -0.30至0.17;P = 0.59;8项研究,382名参与者;低确定性证据)。四项研究报告了与健康相关的生活质量(HR-QoL),三项研究报告了功能障碍。由于研究使用了不同的测量方法,仅对步行障碍问卷(WIQ)距离得分进行了荟萃分析,结果显示两组之间几乎没有差异(MD -5.52,95% CI -17.41至6.36;P = 0.36;2项研究;96名参与者;低确定性证据)。
本综述发现,在改善间歇性跛行患者的最大步行距离和无痛步行距离方面,替代运动模式与监督下步行运动之间没有明显差异。由于临床不一致性、样本量小和存在偏倚风险,该证据的确定性被判定为低等。本综述的结果表明,当监督下步行运动不可行时,替代运动模式可能有用。需要更多方法学质量适当且有足够效力的随机对照试验,为每种替代运动模式与当前监督下跑步机步行标准之间的比较提供确凿证据。未来的随机对照试验应使用标准化测试方法和结局报告,研究步行行为、身体活动、心血管风险和HR-QoL等结局指标,以便在各研究之间进行有意义的比较。