Promote Weight Loss in Obese Peripheral Artery Disease (PAD) Patients to Prevent Mobility Loss

  • STATUS
    Recruiting
  • End date
    May 31, 2027
  • participants needed
    212
  • sponsor
    Northwestern University
Updated on 16 May 2021
arteriopathy
peripheral arterial diseases

Summary

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>28 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 > 28 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.

Details
Condition peripheral arterial disease, Peripheral Arterial Disease (PAD), Peripheral Arterial Disease (PAD), Overweight or Obesity, peripheral arterial diseases, peripheral artery disease
Treatment Exercise, Weight Loss
Clinical Study IdentifierNCT04228978
SponsorNorthwestern University
Last Modified on16 May 2021

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