Exercise and Weight Loss for Obese PAD Patients
(PROVE Trial)
Trial Summary
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Research shows that physical activity and exercise can help with weight loss and improve cardiovascular health, even if the weight loss is modest. Exercise also helps maintain weight loss and improve fitness, which can reduce health risks in obese individuals.
12345Exercise and weight loss programs, including those with behavioral strategies, are generally safe for obese patients and can lead to improvements in health indicators like blood pressure, cholesterol, and insulin sensitivity.
678910This treatment is unique because it combines exercise and weight loss strategies to improve cardiovascular health and manage obesity, which can be more effective than exercise alone. It also emphasizes lifestyle changes and personalized support, such as personal trainers and financial incentives, to enhance adherence and long-term success.
511121314Eligibility Criteria
This trial is for adults over 18 with Peripheral Artery Disease (PAD) and a Body Mass Index (BMI) of more than 25 kg/m2. They should have leg symptoms from PAD that improve with rest, and an ankle brachial index (ABI) below 0.90 or other diagnostic criteria for PAD. People can't join if they've had recent major surgery, are unable to use a smartphone, drink excessively, have certain medical conditions like severe lung disease or cancer under treatment, or if their walking is limited by something other than PAD.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to either weight loss + exercise or exercise alone, with interventions including a Group Mediated Cognitive Behavioral framework, connective mobile technology, remote monitoring by a coach, and a calorie-restricted DASH-derived diet
Follow-up
Participants are monitored for changes in six-minute walk distance, exercise adherence, physical activity, and other health metrics
Exploratory Assessments
In a subset of participants, additional assessments such as calf muscle biopsies are conducted to measure mitochondrial biogenesis, capillary density, and inflammation