Exercise and Weight Loss for Obese PAD Patients
(PROVE Trial)
Trial Summary
What is the purpose of this trial?
The PROVE Trial is a randomized clinical trial that will determine whether a weight loss intervention combined with walking exercise achieves greater improvement or less decline in six-minute walk distance at 12 month follow-up than walking exercise alone in people with PAD and BMI\>25 kg/m2. The intervention uses a Group Mediated Cognitive Behavioral framework, connective mobile technology, remote monitoring by a coach, and a calorie restricted Dietary Approaches to Stop Hypertension (DASH)-derived Optimal Macronutrient Intake Trial for Heart Health (OMNIHeart) diet. 212 participants with PAD and BMI \> 25 kg/m2 will be randomized to one of two groups: weight loss + exercise (WL+EX) vs. exercise alone (EX). Participants will be randomized at Northwestern, Tulane University, and University of Minnesota. Our primary outcome is change in six-minute walk distance at 12-month follow-up. Secondary outcomes are change in 6-minute walk distance at 6-month follow-up and change in exercise adherence, physical activity, patient-reported walking ability (measured by the Walking Impairment Questionnaire (WIQ) distance score), and mobility (measured by the Patient-Reported Outcomes Measurement Information System \[PROMIS\] mobility questionnaire) at 12-month follow-up. Tertiary outcomes are perceived exertional effort (measured by the Borg scale at the end of the 6-minute walk at 12-month follow-up), and diet quality. Exploratory outcomes consist of change in the short physical performance battery (SPPB), the WIQ stair climbing and walking speed scores, and calf muscle biopsy measures at 12-month follow-up. Study investigators will perform calf muscle biopsies in 50 participants to compare changes in mitochondrial biogenesis and activity, capillary density, and inflammation between WL+EX vs. EX.
Will I have to stop taking my current medications?
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.
What data supports the effectiveness of the treatment Exercise, Physical Activity, Workout, Fitness Training, Weight loss, Behavioral Weight Loss Program, Weight Management Program, Lifestyle Intervention for obese PAD patients?
Is exercise and weight loss safe for obese patients?
How does the treatment of exercise and weight loss for obese PAD patients differ from other treatments?
This 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.511121314
Research Team
Mary McDermott, MD
Principal Investigator
Northwestern University
Walter Ambrosius, PhD
Principal Investigator
Wake Forest University
Eligibility 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
Treatment Details
Interventions
- Exercise (Behavioral Intervention)
- Weight loss (Behavioral Intervention)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Northwestern University
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Wake Forest University
Collaborator