# The Effects of Diet and Exercise Interventions in Peripheral Artery Disease

> **NIH NIH R01** · PENNSYLVANIA STATE UNIV HERSHEY MED CTR · 2022 · $508,443

## Abstract

PROJECT SUMMARY
 Objective. Our objective is to build on our preliminary work that demonstrates a modified dietary
approaches to stop hypertension (modDASH) eating plan combined with a standard exercise program will be a
better overall treatment for patients with peripheral artery disease (PAD) to improve walking, local microvascular
function, and vascular inflammation.
 Specific Aims. We propose to test the efficacy of a modDASH dietary program combined with an
exercise program (modDASH+Ex) to improve exercise and vascular outcome measures in patients with PAD
and claudication beyond that of the standard treatment of an exercise program (Ex). Our central hypothesis is
that the modDASH+Ex program improves the efficacy to rehabilitate PAD patients by improving exercise
outcomes, health-related quality of life (HRQoL), local microvascular function, and vascular inflammation more
than the standard Ex program. This clinically relevant hypothesis will be tested through the following aims:
 Aim 1 (Exercise Outcomes). To compare the changes in ambulation and HRQoL in PAD patients
following the combined modDASH+Ex program, and following the Ex program which represents standard of care
treatment.
 Aim 2 (Local and Systemic Vascular Outcomes). To compare the changes in local microvascular
function of the lower extremities and inflammation in patients following the combined modDASH+Ex program, and
following the Ex program.
 Aim 3. To explore the causal mechanism that changes in local microvascular function and vascular
inflammation are physiologic mechanisms that precede changes in ambulation following the modDASH+Ex
and Ex programs, and whether changes are more predictive following modDASH+Ex program.
 Methods. This is a 3-month, patient-oriented, translational, comparative effectiveness randomized
controlled trial. A total of 184 patients will be randomized into either the modDASH+Ex program (N=92) or the Ex
program (N=92). All patients will perform home-based walking for 3 months, and patients randomized to the
modDASH+Ex program will progressively increase their daily servings of fruits and vegetables by up to 3-4
servings above baseline during the program.
 Clinical Significance. If successful, combining the modDASH eating plan with a home-based exercise
program will be a novel and innovative behavioral paradigm to optimally improve peak walking time, HRQoL, local
microvascular function and vascular inflammation in PAD patients. These improvements could impact the clinical
course of PAD by reducing long-term risks of major adverse cardiovascular and lower extremity events.

## Key facts

- **NIH application ID:** 10445408
- **Project number:** 1R01AG070086-01A1
- **Recipient organization:** PENNSYLVANIA STATE UNIV HERSHEY MED CTR
- **Principal Investigator:** Andrew W Gardner
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $508,443
- **Award type:** 1
- **Project period:** 2022-09-01 → 2027-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10445408

## Citation

> US National Institutes of Health, RePORTER application 10445408, The Effects of Diet and Exercise Interventions in Peripheral Artery Disease (1R01AG070086-01A1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10445408. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*