Abstract

Background: Home-based walking exercise improves walking performance in people with lower extremity peripheral artery disease (PAD). However, whether clinical and sociodemographic factors, such as age, sex, race, comorbidities, and income, are associated with response to exercise or rates of serious adverse events (SAEs) during a home-based walking exercise intervention for PAD is unclear. Methods: Data from participants randomized to two clinical trials of home-based walking exercise for PAD were pooled. Both clinical trials used behavioral methods to help participants adhere to walking exercise up to 5 days/week for up to 50 minutes/session for 6-months. Outcomes were change in six-minute walk (6MW) at 6-months and rates of SAEs at 12-months. SAEs were defined as death or hospitalization. Results: 325 unique participants [mean age 69.8 (9.1), 161 (49.5%) female, 182 (56.0%) Black] had available 6MW and SAE data. Home-based walking exercise improved 6MW distance, compared to control, at 6-month follow-up [mean: +46.4 meters (95% CI: +31.5 meters, 61.2 meters)]. The effect of home-based exercise on 6MW was similar across clinical and sociodemographic characteristics. 51 (27.3%) participants reported SAEs in the home-based exercise group and 32 (23.2%) reported SAEs in the control group (p=0.40). Among those randomized to home-based walking exercise, odds of SAE were significantly higher among Black compared to White participants, those with history of coronary artery disease (CAD) and heart failure (HF) compared to those without (Figure). Statistically significant interactions were identified between Black race (P<0.001), coronary artery disease (P=0.006) and lower income zipcodes (P=0.047) and the effect of exercise on rates of SAEs. Conclusion: In people with PAD randomized to home-based exercise, those who were Black, had a history of CAD or HF were significantly more likely to experience SAEs, compared to people without these characteristics.

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