Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Claudication
  • Peripheral Artery Disease
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Prospective, randomized controlled clinical trialMasking: Single (Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Younger than 125 years
Gender
Both males and females

Description

This study seeks to (1) compare the changes in 6-minute walk distance (6MWD) and physical function quality of life in patients with peripheral artery disease (PAD) following a combined intervention of the dietary approaches to stop hypertension (DASH) dietary program plus a home-based exercise progr...

This study seeks to (1) compare the changes in 6-minute walk distance (6MWD) and physical function quality of life in patients with peripheral artery disease (PAD) following a combined intervention of the dietary approaches to stop hypertension (DASH) dietary program plus a home-based exercise program, and following a home-based exercise program alone; and (2) compare the changes in microvascular function and inflammation in patients following the combined DASH diet and home-based exercise program, and the home-based exercise program alone. The investigators hypothesize that the combined DASH diet and exercise program will result in greater increases in 6MWD and in the physical function quality of life than the exercise program alone. Further, it is hypothesized that the combined DASH diet and exercise program will result in greater improvements in calf muscle oxygen saturation [StO2] following exercise, and in high-sensitivity C-reactive protein (hsCRP]) than the exercise program alone. The home-based exercise program consists of intermittent walking to moderate claudication pain in a home-based setting. The DASH dietary program consists of the dietary approaches to stop hypertension diet emphasizing foods rich in fruits, vegetables, whole grains, and low-fat dairy.

Tracking Information

NCT #
NCT03845036
Collaborators
Not Provided
Investigators
Not Provided