A "test in-train out" program versus a "go home and walk" intervention for home-based exercise therapy in patients with peripheral artery disease: A randomized controlled trial

Objective: In this single-blinded randomized controlled trial, we compared the "Test in-Train Out" structured home-based exercise program (TiTo-SHB) with the traditional "go home and walk" exercise intervention in people with peripheral artery disease (PAD). Methods: Peripheral artery disease patients at Leriche-Fontaine's stage II were randomized to receive TiTo-SHB or walking advice (C-WA). The TiTo-SHB group performed two daily 8-min sessions of pain-free interval walking at progressive low-to-moderate speed maintained with a metronome. The C-WA group was recommended to walk for 30 min at least three times per week and to endure claudication pain. Outcomes collected at baseline and at the end of the program (6 months) included: 6-min and pain-free walking distance (6MWD, PFWD), ankle-brachial index (ABI), 5-time sit-to-stand test (5STS), and health-related quality of life (HRQoL) by the VascuQoL-6 questionnaire. Results: A total of 68 patients were randomized (males n = 50; aged 73 +/- 9; TiTo-SHB n = 34). At the end of the program, patients in the TiTo-SHB group compared with the C-WA group had significantly improved 6MWD (Delta + 60 +/- 32 m vs. Delta - 5 +/- 37 m; p < 0.001) and PFWD (Delta + 140 +/- 92 m vs. Delta - 7 +/- 87 m; p < 0.001). A significant between-group difference in favor of the TiTo-SHB group was also recorded for all the secondary outcomes, including 5STS (Delta - 2.6 +/- 1.8 s vs. Delta + 0.8 +/- 2.6 s; p < 0.001), ABI of the more impaired limb (Delta + 0.10 +/- 0.11 vs. Delta + 0.02 +/- 0.08; p = 0.003), and VascuQoL-6 score (Delta +2 +/- 2 vs. -1 +/- 4; p < 0.001). Conclusion: In PAD patients with claudication, the pain-free in-home TiTo-SHB program was more effective in improving exercise capacity and HRQoL than the traditional walking advice recommendation.