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Effects of supervised exercise therapy on blood pressure and heart rate during exercise, and associations with improved walking performance in peripheral artery disease: results of a randomized clinical trial [with consumer summary]
Slysz JT, Tian L, Zhao L, Zhang D, McDermott MM
Journal of Vascular Surgery 2021 Nov;74(5):1589-1600
clinical trial
5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

OBJECTIVE: Supervised exercise therapy (SET) improves walking ability in people with peripheral artery disease (PAD). However, the effects of SET on cardiovascular health in PAD remains unclear. Using data from a randomized clinical trial, this post-hoc study investigated the effects of a 6-month SET intervention, compared to a control group, on changes in blood pressure (BP) and heart rate (HR) during a graded treadmill exercise test (GXT) in people with PAD. METHODS: 210 participants with PAD were randomized to either SET (3x weekly) or control (1x weekly health lectures) for 6 months. A GXT, six-minute walk (6MW) test, and Walking Impairment Questionnaire (WIQ) were completed at baseline and 6-month follow-up. BP and HR were measured at the end of each 2-min stage of the GXT. Mixed-effects regression models compared the overall mean 6-month change in systolic BP, diastolic BP, pulse pressure (PP), and HR during the first 5 stages of the GXT between groups. RESULTS: Of 210 randomized, 176 participants with PAD (67 +/- 9 years, 72 (41%) female, 115 (65%) black) completed the GXT at baseline and 6-month follow-up. Compared to the control group at 6-month follow-up, SET significantly decreased overall mean systolic BP (-12 mmHg; p < 0.001), PP (-9 mmHg; p < 0.001), and HR (-7 b/min; p < 0.01) during a GXT but not diastolic BP. Among participants randomized to SET, a greater reduction in systolic BP, PP, and HR during a GXT was significantly associated with greater improvement in 6MW distance (systolic BP r = -0.19; p = 0.03 and PP r = -0.23; p < 0.01 and HR r = -0.21; p < 0.01) and with maximal treadmill walking distance (systolic BP r = -0.21; p < 0.01 and PP r = -0.17; p = 0.03) at 6-month follow-up. A greater reduction in HR during a GXT was significantly associated with a better WIQ distance score (r = -0.27; p = 0.03) at 6-month follow up. CONCLUSIONS: In people with PAD, compared to a control group, SET improved cardiovascular health, measured by changes in BP and HR during exercise. The degree of improvement in cardiovascular health correlated with the degree of improvement in walking performance in people with PAD. NCT01408901.

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