Study Design, Rationale, and Methodology for Promote Weight Loss in Patients With Peripheral Artery Disease Who Also Have Obesity: The PROVE Trial.

Background Overweight and obesity are associated with adverse functional outcomes in people with peripheral artery disease (PAD). The effects of weight loss in people with overweight/obesity and PAD are unknown. Methods The PROVE (Promote Weight Loss in Obese PAD Patients to Prevent Mobility Loss) Trial is a multicentered randomized clinical trial with the primary aim of testing whether a behavioral intervention designed to help participants with PAD lose weight and walk for exercise improves 6-minute walk distance at 12-month follow-up, compared with walking exercise alone. A total of 212 participants with PAD and body mass index ≥25 kg/m2 will be randomized. Interventions are delivered using a Group Mediated Cognitive Behavioral intervention model, a smartphone application, and individual telephone coaching. The primary outcome is 12-month change in 6-minute walk distance. Secondary outcomes include total minutes of walking exercise/wk at 12-month follow-up and 12-month change in accelerometer-measured physical activity, the Walking Impairment Questionnaire distance score, and the Patient-Reported Outcomes Measurement Information System mobility questionnaire. Tertiary outcomes include 12-month changes in perceived exertional effort at the end of the 6-minute walk, diet quality, and the Short Physical Performance Battery. Exploratory outcomes include changes in gastrocnemius muscle biopsy measures of mitochondrial cytochrome C oxidase activity, mitochondrial biogenesis, capillary density, and inflammatory markers. Conclusions The PROVE randomized clinical trial will evaluate the effects of exercise with an intervention of coaching and a smartphone application designed to achieve weight loss, compared with exercise alone, on walking performance in people with PAD and overweight/obesity. Results will inform optimal treatment for the growing number of patients with PAD who have overweight/obesity. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT04228978.

Adherence and exercise mode in supervised exercise therapy for peripheral artery disease.

Supervised exercise therapy (SET) is a first-line treatment for people with peripheral artery disease (PAD). However, data on patient adherence to SET are limited. In addition, while intermittent treadmill exercise has been widely tested, no studies have investigated recumbent total body stepping (step-ex). We examined whether exercise mode (treadmill walking [n = 17], step-ex [n = 18], or a multimodal approach [n = 18]) affected adherence to a 12-week SET program. We also investigated the potential safety and viability of step-ex for people with PAD by looking at change in exercise training capacity (highest metabolic equivalent of tasks [METs] achieved and highest total MET-minutes achieved per session). The 53 participants comprised 50% female candidates (n = 26) and were (mean [SD]) 74.2 (8.3) years old, with an ankle-brachial index of 0.70 (0.19). Overall adherence to SET was 62%. There was a difference in adherence between groups (P = .022), with the multimodal group (73.6% [21.5%]) higher than the treadmill group (50.2% [28.8%], P = .010). Treadmill participants (n [%]) (8 [47.1%]) dropped out at a higher rate than the multimodal group (3 [16.7%], P = .053). All groups increased the exercise training capacity. The multimodal group achieved greater improvement in total MET-minutes achieved per session (61.5 [45.1]) than the treadmill group (14.7 [44.3]) (P = .008).A multimodal approach to PAD exercise therapy resulted in higher adherence and greater change in exercise training capacity. Step-ex was safe for people with PAD. While further study is warranted, it is appropriate for SET programs to consider a multimodal approach using step-ex, especially given the varied health and physical ability of the PAD population.