Diet and Exercise Interventions to Treat Claudication
Last updated on July 2021Recruitment
- 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