Abstract | PURPOSE: To determine whether a percutaneous vascular intervention (PVI) combined with supplemental supervised exercise therapy (SET) is more effective than a PVI alone in improving walking ability in patients with symptomatic peripheral arterial disease (PAD). MATERIALS AND METHODS: In this prospective randomized trial, patients with PAD treated with a PVI were eligible. Exclusion criteria were major amputation or tissue loss, comorbidity preventing physical activity, insufficient knowledge of the Dutch language, no insurance for SET, and prior participation in a SET program. All patients received a PVI and subsequently were randomly assigned to either the PVI alone group (n = 35) or the PVI + SET group (n = 35). The primary outcome parameter was the absolute claudication distance (ACD). This trial was registered at Clinical trials.gov, NCT00497445. RESULTS: The study included 70 patients, most of whom were treated for an aortoiliac lesion. The mean difference in ACD at 6 months of follow-up was 271.3 m (95% confidence interval [CI] 64.0-478.6, P = .011) in favor of additional SET. In the PVI alone group, 1 (3.7%) patient finished the complete treadmill test compared with 11 (32.4%) patients in the PVI + SET group (P = .005). Physical health-related quality-of-life score was 44.1 ± 7.8 in the PVI alone group compared with 41.9 ± 9.5 in the PVI + SET group, which was a nonsignificant difference (P = .34). CONCLUSIONS: SET following a PVI is more effective in increasing walking distance compared with a PVI alone. These data indicate that SET is a useful adjunct to a PVI for the treatment of PAD.
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Authors | Lotte M Kruidenier, Saskia P Nicolaï, Ellen V Rouwet, Ron J Peters, Martin H Prins, Joep A W Teijink |
Journal | Journal of vascular and interventional radiology : JVIR
(J Vasc Interv Radiol)
Vol. 22
Issue 7
Pg. 961-8
(Jul 2011)
ISSN: 1535-7732 [Electronic] United States |
PMID | 21571547
(Publication Type: Journal Article, Randomized Controlled Trial)
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Copyright | Copyright © 2011 SIR. Published by Elsevier Inc. All rights reserved. |
Topics |
- Aged
- Ankle Brachial Index
- Chi-Square Distribution
- Combined Modality Therapy
- Endovascular Procedures
- Exercise Test
- Exercise Therapy
- Female
- Hemodynamics
- Humans
- Intermittent Claudication
(etiology, physiopathology, therapy)
- Male
- Middle Aged
- Netherlands
- Peripheral Arterial Disease
(complications, physiopathology, therapy)
- Prospective Studies
- Quality of Life
- Recovery of Function
- Regression Analysis
- Surveys and Questionnaires
- Time Factors
- Treatment Outcome
- Walking
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