Objective: Home-based walking exercise is first-line therapy for peripheral artery disease (PAD), but benefits of home-based walking exercise are variable. This study evaluated whether specific clinical characteristics were associated with greater improvement after home-based walking exercise or with higher rates of serious adverse events (SAEs).
Methods: Data were combined from two randomized clinical trials comparing home-based walking exercise with control in PAD. The home-based exercise interventions used behavioral interventions to help participants adhere to exercise. The primary outcome was the proportion of PAD participants who improved 6-minute walk (6 MW) by at least 20 meters. Serious adverse events consisted of overnight hospitalizations or death that occurred during the randomized clinical trial.
Results: Of 376 participants with PAD (69.6 years; 54.5% Black; 49.5% women), 217 were randomized to exercise and 159 to control. Home-based exercise improved 6 MW by at least 20 meters in 100 participants (54.9%), compared with 37 (28.0%) in control (odds ratio, 3.13; 95% confidence interval, 1.94-5.06; P < .001. Age, sex, race, comorbidities, baseline 6 MW, and income did not significantly alter the effect of home-based exercise on improved 6 MW. SAEs occurred in 28.1% and 23.3% of participants randomized to exercise and control, respectively (P = .29). There were statistically significant interactions, indicating that home-based exercise increased SAE rates, compared with control, in Black compared with non-Black participants (P interaction < .001), in those with vs without coronary artery disease (CAD) (P interaction < .001), and in people with vs without history of heart failure (P interaction = .005).
Conclusions: Among people with PAD, home-based exercise improved 6 MW by at least 20 meters in 54.9% of people. Older age, female sex, Black race, and specific comorbidities were not associated with lower rates of attaining meaningful improvement in 6 MW following home-based exercise. Further study is needed to establish whether certain patient characteristics, such as history of coronary artery disease, may affect SAE rates in patients with PAD participating in home-based exercise.