Modes of exercise training for intermittent claudication.

BACKGROUND: 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. OBJECTIVES: To assess the effects of alternative modes of supervised exercise therapy compared to traditional walking exercise in patients with intermittent claudication. SEARCH METHODS: 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. SELECTION CRITERIA: 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. DATA COLLECTION AND ANALYSIS: 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. MAIN RESULTS: 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.

Protocol for a prospective, longitudinal cohort study on the effect of arterial disease level on the outcomes of supervised exercise in intermittent claudication: the ELECT Registry.

INTRODUCTION: Despite guideline recommendations advocating conservative management before invasive treatment in intermittent claudication, early revascularisation remains widespread in patients with favourable anatomy. The aim of the Effect of Disease Level on Outcomes of Supervised Exercise in Intermittent Claudication Registry is to determine the effect of the location of stenosis on the outcomes of supervised exercise in patients with intermittent claudication due to peripheral arterial disease. METHODS AND ANALYSIS: This multicentre prospective cohort study aims to enrol 320 patients in 10 vascular centres across the Netherlands. All patients diagnosed with intermittent claudication (peripheral arterial disease: Fontaine II/Rutherford 1-3), who are considered candidates for supervised exercise therapy by their own physicians are appropriate to participate. Participants will receive standard care, meaning supervised exercise therapy first, with endovascular or open revascularisation in case of insufficient effect (at the discretion of patient and vascular surgeon). For the primary objectives, patients are grouped according to anatomical characteristics of disease (aortoiliac, femoropopliteal or multilevel disease) as apparent on the preferred imaging modality in the participating centre (either duplex, CT angiography or magnetic resonance angiography). Changes in walking performance (treadmill tests, 6 min walk test) and quality of life (QoL; Vascular QoL Questionnaire-6, WHO QoL Questionnaire-Bref) will be compared between groups, after multivariate adjustment for possible confounders. Freedom from revascularisation and major adverse cardiovascular disease events, and attainment of the treatment goal between anatomical groups will be compared using Kaplan-Meier survival curves. ETHICS AND DISSEMINATION: This study has been exempted from formal medical ethical approval by the Medical Research Ethics Committees United 'MEC-U' (W17.071). Results are intended for publication in peer-reviewed journals and for presentation to stakeholders nationally and internationally. TRIAL REGISTRATION NUMBER: NTR7332; Pre-results.