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- Title
Effect of Low-Intensity vs High-Intensity Home-Based Walking Exercise on Walk Distance in Patients With Peripheral Artery Disease: The LITE Randomized Clinical Trial.
- Authors
McDermott, Mary M.; Spring, Bonnie; Tian, Lu; Treat-Jacobson, Diane; Ferrucci, Luigi; Lloyd-Jones, Donald; Zhao, Lihui; Polonsky, Tamar; Kibbe, Melina R.; Bazzano, Lydia; Guralnik, Jack M.; Forman, Daniel E.; Rego, Al; Zhang, Dongxue; Domanchuk, Kathryn; Leeuwenburgh, Christiaan; Sufit, Robert; Smith, Brittany; Manini, Todd; Criqui, Michael H.
- Abstract
<bold>Importance: </bold>Supervised high-intensity walking exercise that induces ischemic leg symptoms is the first-line therapy for people with lower-extremity peripheral artery disease (PAD), but adherence is poor.<bold>Objective: </bold>To determine whether low-intensity home-based walking exercise at a comfortable pace significantly improves walking ability in people with PAD vs high-intensity home-based walking exercise that induces ischemic leg symptoms and vs a nonexercise control.<bold>Design, Setting, and Participants: </bold>Multicenter randomized clinical trial conducted at 4 US centers and including 305 participants. Enrollment occurred between September 25, 2015, and December 11, 2019; final follow-up was October 7, 2020.<bold>Interventions: </bold>Participants with PAD were randomized to low-intensity walking exercise (n = 116), high-intensity walking exercise (n = 124), or nonexercise control (n = 65) for 12 months. Both exercise groups were asked to walk for exercise in an unsupervised setting 5 times per week for up to 50 minutes per session wearing an accelerometer to document exercise intensity and time. The low-intensity group walked at a pace without ischemic leg symptoms. The high-intensity group walked at a pace eliciting moderate to severe ischemic leg symptoms. Accelerometer data were viewable to a coach who telephoned participants weekly for 12 months and helped them adhere to their prescribed exercise. The nonexercise control group received weekly educational telephone calls for 12 months.<bold>Main Outcomes and Measures: </bold>The primary outcome was mean change in 6-minute walk distance at 12 months (minimum clinically important difference, 8-20 m).<bold>Results: </bold>Among 305 randomized patients (mean age, 69.3 [SD, 9.5] years, 146 [47.9%] women, 181 [59.3%] Black patients), 250 (82%) completed 12-month follow-up. The 6-minute walk distance changed from 332.1 m at baseline to 327.5 m at 12-month follow-up in the low-intensity exercise group (within-group mean change, -6.4 m [95% CI, -21.5 to 8.8 m]; P = .34) and from 338.1 m to 371.2 m in the high-intensity exercise group (within-group mean change, 34.5 m [95% CI, 20.1 to 48.9 m]; P < .001) and the mean change for the between-group comparison was -40.9 m (97.5% CI, -61.7 to -20.0 m; P < .001). The 6-minute walk distance changed from 328.1 m at baseline to 317.5 m at 12-month follow-up in the nonexercise control group (within-group mean change, -15.1 m [95% CI, -35.8 to 5.7 m]; P = .10), which was not significantly different from the change in the low-intensity exercise group (between-group mean change, 8.7 m [97.5% CI, -17.0 to 34.4 m]; P = .44). Of 184 serious adverse events, the event rate per participant was 0.64 in the low-intensity group, 0.65 in the high-intensity group, and 0.46 in the nonexercise control group. One serious adverse event in each exercise group was related to study participation.<bold>Conclusions and Relevance: </bold>Among patients with PAD, low-intensity home-based exercise was significantly less effective than high-intensity home-based exercise and was not significantly different from the nonexercise control for improving 6-minute walk distance. These results do not support the use of low-intensity home-based walking exercise for improving objectively measured walking performance in patients with PAD.<bold>Trial Registration: </bold>ClinicalTrials.gov Identifier: NCT02538900.
- Subjects
PHYSIOLOGICAL aspects of walking; PERIPHERAL vascular diseases; LEG diseases; CLINICAL trials; EXERCISE physiology; PERIPHERAL vascular disease treatment; ISCHEMIA treatment; RESEARCH; SKELETAL muscle; BIOPSY; RESEARCH methodology; MEDICAL cooperation; EVALUATION research; LEG; COMPARATIVE studies; RANDOMIZED controlled trials; WALKING; EXERCISE therapy
- Publication
JAMA: Journal of the American Medical Association, 2021, Vol 325, Issue 13, p1266
- ISSN
0098-7484
- Publication type
journal article
- DOI
10.1001/jama.2021.2536