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Effect of aspirin versus clopidogrel on walking exercise performance in intermittent claudication-a double-blind randomized multicenter trial.

ABSTRACT: This study sought to determine possible effects of different antiplatelet therapies on walking exercise performance in intermittent claudication. Aspirin, in contrast to clopidogrel, interferes with processes that increase collateral conductance in an ischemic animal model.Patients with stable intermittent claudication were recruited from 21 centers in Switzerland and Germany and randomized to either aspirin or clopidogrel treatment. They participated in a 3-month rehabilitation program (electronically monitored, home-based, 1-hour daily walking sessions at a speed of approximately 120 steps/min). Walking distance was assessed by treadmill tests (3.2 km/h; 12% grade) at baseline and after 12 weeks. A total of 229 of 259 patients with a mean age of 66.2±7.7 years completed the study according to the protocol. A total of 24.5% were females, 20.1% diabetics, and 85.6% were active/ex-smokers. The baseline characteristics were a median (interquartile range) ankle/brachial index of 0.69 (0.57±0.8), an initial claudication distance (ICD) of 98 m (70 to 151 m), and an absolute claudication distance (ACD) of 162 m (113 to 302 m). Training resulted in a median increase of initial claudication distance by 33.5 m (33.3%) in the clopidogrel group and 29 m (33.9%) in the aspirin group. The values for absolute claudication distance were 60.5 m (34.9%) and 75 m (35.3%), respectively (p(ICD)=0.42 and p(ACD)=0.66).Treatment with aspirin did not show a difference in initial claudication distance or absolute claudication distance improvements compared with clopidogrel after a 3-month walking rehabilitation program. (J Am Heart Assoc. 2012;1:51-56.)URL: http://www.ClinicalTrials.gov. Unique identifier: NCT00189618, URL: https://EudraCT.ema.europa.eu, Unique identifier: 2004-005041-35.

SUBMITTER: Singer E

PROVIDER: S-EPMC3487315 | biostudies-literature | 2012 Feb

REPOSITORIES: biostudies-literature

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Effect of aspirin versus clopidogrel on walking exercise performance in intermittent claudication-a double-blind randomized multicenter trial.

Singer Elisabeth E Imfeld Stephan S Staub Daniel D Hoffmann Ulrich U Buschmann Ivo I Labs Karl-Heinz KH Jaeger Kurt A KA

Journal of the American Heart Association 20120220 1

<h4>Background</h4>This study sought to determine possible effects of different antiplatelet therapies on walking exercise performance in intermittent claudication. Aspirin, in contrast to clopidogrel, interferes with processes that increase collateral conductance in an ischemic animal model.<h4>Methods and results</h4>Patients with stable intermittent claudication were recruited from 21 centers in Switzerland and Germany and randomized to either aspirin or clopidogrel treatment. They participat ...[more]

PMID: 23130118

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Project description:Background: The short-term benefits of aerobic and resistance exercise in subjects affected by Peripheral Arterial Disease (PAD) are scarcely examined in interaction. This study aimed to identify the effects of combined aerobic and resistance exercise programs on walking performance compared with isolated aerobic exercise or with the usual care in patients with intermittent claudication. Methods: A systematic review was conducted following the PRISMA statement. A total of five electronic databases were searched (until October 2019) for randomized and non-randomized controlled trials. The focus comprised PAD patients with intermittent claudication who performed a combined aerobic and resistance exercise program that assessed the walking performance. Results: Seven studies include combined aerobic and resistance exercise vs. isolated aerobic or vs. usual care. The studies represented a sample size of 337 participants. The follow-up ranged from 4 to 12 weeks, 2 to 5 times-per-week. The risk of bias in the trials was a deemed moderate-to-high risk. After the interventions, the percent change in walking performance outcomes had a large variation. In the combined and isolated aerobic programs, the walking performance always improved, while in the usual care group oscillates between the deterioration and the improvement in all outcomes. Combined exercise and isolated aerobic exercise improved the claudication onset distance from 11 to 396%, and 30 to 422%, the absolute claudication distance from 81 to 197%, and 53 to 121%, and the maximal walking distance around 23 and 10%, respectively. Conclusions: Currently, there is insufficient evidence about the effects of combined aerobic and resistance exercise compared to isolated aerobic exercise or usual care on walking performance. However, despite the low quality of evidence, the combined aerobic and resistance exercise seems to be an effective strategy to improve walking performance in patients with intermittent claudication. These combined exercise modes or isolated aerobic exercise produce positive and significant results on walking performance. The usual care approach has a trend to deteriorate the walking performance. Thus, given the scarcity of data, new randomized controlled trial studies that include assessments of cardiovascular risk factors are urgently required to better determine the effect of this exercise combination.

Project description:ObjectivesPatient-reported outcome measures can facilitate the assessment of walking impairment in peripheral artery disease patients with intermittent claudication in clinical trials and practice. The aim of this study was to test the psychometric properties of the German version of the 'Walking Estimated-Limitation Calculated by History' (WELCH) questionnaire.MethodsThe assessed properties included feasibility, test-retest reliability, construct validity (i.e., convergent, divergent and known-groups validity) and responsiveness using classic psychometric methods. Psychometric properties were tested as part of a randomized controlled home-based exercise trial for patients with symptomatic peripheral artery disease at Fontaine stage IIA/B.ResultsAnalyses were conducted in subgroups of 1,696 patients at baseline and 1,233 patients at 12-month follow-up (i.e., post-intervention) who completed the WELCH along with a battery of other self-report measures. The WELCH did not exhibit relevant floor or ceiling effects (< 15% achieved lowest or highest possible scores), showed evidence for good test-retest reliability (ICC = .81, 95% CI [.71-.88]) and was found to be well suited for self-completion by patients (< 5% missing data per item). WELCH scores showed moderate to strong correlations with related measures of walking impairment at both time points (Walking Impairment Questionnaire: r = .56 - .74; VascuQoL-25 activity subscale: r = .61 - .66) and distinguished well among patients with poor and high quality of life when adjusting for confounders (t = 13.67, p < .001, d = .96). Adequate divergent validity was indicated by a weaker correlation between the WELCH and general anxiety at both time points (GAD-7: r = - .14 to - .22). The WELCH improved by 6.61 points (SD = 17.04, 95% CI [5.13-8.10], d = 0.39) in response to exercise treatment and was able to identify large clinically important improvements observed on the walking distance (AUC = .78, 95% CI [.71-.84]) and speed subscales (AUC = .77, 95% CI [.68-.86]) of the Walking Impairment Questionnaire.ConclusionsThe WELCH is considered a feasible, reliable and valid patient-reported outcome measure for the measurement of walking impairment in patients with peripheral artery disease. The WELCH showed evidence for responsiveness to changes in walking impairment, yet further studies are warranted to conclusively determine the WELCH's ability to detect intervention effects.

Dataset Information

Effect of aspirin versus clopidogrel on walking exercise performance in intermittent claudication-a double-blind randomized multicenter trial.

Publications

Effect of aspirin versus clopidogrel on walking exercise performance in intermittent claudication-a double-blind randomized multicenter trial.

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