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| Effects of 12 weeks of supervised exercise after endovascular treatment: a randomized clinical trial |
| Bo E, Bergland A, Stranden E, Jorgensen JJ, Sandbaek G, Grotta OJ, Hisdal J |
| Physiotherapy Research International 2015 Sep;20(3):147-157 |
| clinical trial |
| 8/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
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BACKGROUND AND PURPOSE: This study aimed to assess the effects of supervised exercise training (SET) after percutaneous transluminal angioplasty (PTA) compared with PTA alone on physical function, limb hemodynamics and health-related quality of life in patients with intermittent claudication. METHODS: Fifty patients who all underwent PTA for intermittent claudication were included in the study. Both groups received usual post-operative care. In addition, the intervention group performed two sessions of hospital-based SET and one home-based exercise session per week for 12 weeks after PTA. The control group did not receive any additional follow-up regarding exercise. The primary outcome was the result of a standardized 6-minute walk test. Secondary outcomes were the treadmill maximum walking distance, treadmill pain-free walking distance, ankle-brachial index, pulse volume recording on the leg and ultrasound scanning. Health-related quality of life was measured using the Short Form 36 and the Claudication Scale. RESULTS: All measures, except for the Short Form 36 domain of mental health, showed statistically significant positive changes from baseline to 3 months for both groups (p < 0.05). At 3 months, there was a trend towards better results for the intervention group compared with the control group. The median improvement from baseline to 3 months for the 6-minute walk test was 66 m for the intervention group and 45 m for the control group. For maximum walking distance, the median improvement was 251 m for the intervention group and 93 m for the control group. DISCUSSION: Supervised exercise training after endovascular treatment for patients with intermittent claudication led to greater positive changes after 3 months in the intervention group compared with the control group. The present study's trends of better results with SET after PTA add to the emerging existing evidence, which should encourage physiotherapy practice to offer SET for this patient group.
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