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Randomized Controlled Trial
. 2015 Aug;20(4):339-47.
doi: 10.1177/1358863X15572725. Epub 2015 Mar 9.

Community-based walking exercise for peripheral artery disease: An exploratory pilot study

Affiliations
Randomized Controlled Trial

Community-based walking exercise for peripheral artery disease: An exploratory pilot study

Ryan J Mays et al. Vasc Med. 2015 Aug.

Abstract

Supervised walking exercise is an effective treatment to improve walking ability of patients with peripheral artery disease (PAD), but few exercise programs in community settings have been effective. The aim of this study was to determine the efficacy of a community-based walking exercise program with training, monitoring and coaching (TMC) components to improve exercise performance and patient-reported outcomes in PAD patients. This was a randomized, controlled trial including PAD patients (n=25) who previously received peripheral endovascular therapy or presented with stable claudication. Patients randomized to the intervention group received a comprehensive community-based walking exercise program with elements of TMC over 14 weeks. Patients in the control group did not receive treatment beyond standard advice to walk. The primary outcome in the intent-to-treat (ITT) analyses was peak walking time (PWT) on a graded treadmill. Secondary outcomes included claudication onset time (COT) and patient-reported outcomes assessed via the Walking Impairment Questionnaire (WIQ). Intervention group patients (n=10) did not significantly improve PWT when compared with the control group patients (n=10) (mean ± standard error: +2.1 ± 0.7 versus 0.0 ± 0.7 min, p=0.052). Changes in COT and WIQ scores were greater for intervention patients compared with control patients (COT: +1.6 ± 0.8 versus -0.6 ± 0.7 min, p=0.045; WIQ: +18.3 ± 4.2 versus -4.6 ± 4.2%, p=0.001). This pilot using a walking program with TMC and an ITT analysis did not improve the primary outcome in PAD patients. Other walking performance and patient self-reported outcomes were improved following exercise in community settings. Further study is needed to determine whether this intervention improves outcomes in a trial employing a larger sample size.

Keywords: activity monitors; claudication; environmental audit; unsupervised exercise.

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Conflict of interest statement

Conflicts of interest

Dr. Hiatt is the director of a clinical trials research organization (CPC Clinical Research) that manages trials evaluating new treatments for PAD. Sponsors for relevant projects include Pluristem, AstraZeneca, Bayer, the Cardiovascular Cell Therapy Research Network and Cardiovascular Systems, Inc. The other authors note no conflicts.

Figures

Figure 1
Figure 1
Primary walking performance outcome from the ITT and exploratory analyses at baseline and 14 weeks for intervention and control group patients. Data presented as means±standard error. aSignificantly greater than control group peak walking time change scores within the exploratory analysis, p=0.037. bRemoval of patient with advanced metastatic cancer from analysis (intervention group: n=9). ITT, intent-to-treat.
Figure 2
Figure 2
Secondary walking performance outcome from the intent-to-treat and exploratory analyses at baseline and 14 weeks for intervention and control group patients. aSignificant change score improvement compared to control group within the intent-to-treat analysis, p=0.045. bSignificantly greater change score between intervention and control group patients within the exploratory analysis, p=0.046. cRemoval of one patient who did not experience claudication symptoms from the intent-to-treat analysis (intervention group: n=9). dRemoval of patient with advanced metastatic cancer and the patient who did not experience claudication symptoms from the exploratory analysis (intervention group: n=8).

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