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| Home-based exercise and patient-reported outcome measures in peripheral artery disease: the LITE randomized clinical trial |
| Whipple MO, Xu S, Zhang D, Guralnik J, Spring B, Tian L, Treat-Jacobson D, Zhao L, Criqui MH, McDermott MM |
| The American Journal of Cardiology 2025 Jun 1;244:41-47 |
| clinical trial |
| This trial has not yet been rated. |
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In patients with peripheral artery disease (PAD), we evaluated the effects of 12 months of walking exercise at a pace inducing ischemic leg symptoms (high intensity) on the attainment of meaningful improvement in patient-reported outcome measures (PROMs) and 6-minute walk, compared to walking exercise at a comfortable pace (low intensity) and a nonexercise control. Participants completed the 6-minute walk test (6MWT) to evaluate objective walking ability. PROMs included the Walking Impairment Questionnaire (WIQ) distance and speed scores (range 0 to 100, 100-best, minimal clinically important difference (MCID) 15 and 11, respectively). 240 participants (61.7% Black, 48.3% female) participated. High intensity exercise increased 6MWT compared to control (+44.8 meters (95% CI 21.7 to 68.0) and compared to low-intensity exercise (+37.6 meters (95% CI 18.6 to 56.5)). Low intensity exercise had no significant benefit compared to control (+7.3 meters (95% CI -16.3 to 30.9)). High intensity significantly increased attainment of the MCID for the 6MWT compared to low intensity (OR 2.43 (95% CI 1.35 to 4.38)) and compared to control (OR 5.22 (95% CI 2.32 to 11.76)). Compared to control, high intensity exercise significantly increased the odds of attaining an MCID for the WIQ distance score (OR 2.30 (95% CI 1.05 to 5.04)) and WIQ speed score (OR 2.94 (95% CI 1.27 to 6.83)). Compared to low intensity, high intensity did not significantly increase the odds of attaining an MCID for the WIQ distance (OR 0.93 (95% CI 0.53 to 1.66)) or the WIQ speed score (OR 1.31 (95% CI 0.71 to 2.43)). In conclusion, in people with PAD, high intensity walking exercise increased the odds of meaningful improvement in PROMs compared to control, but not compared to low-intensity exercise. Despite this, high intensity exercise improved 6MWT more than the low intensity exercise and nonexercise control groups (NCT02538900).
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