Effects of diet and exercise on patients with peripheral artery disease
The Effects of Diet and Exercise Interventions in Peripheral Artery Disease
This study is testing whether a special diet and exercise program together can help people with peripheral artery disease walk better and feel healthier compared to just exercising at home.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | University of Oklahoma Academic / other |
| Locations | 1 site (Oklahoma City, Oklahoma) |
| Trial ID | NCT03845036 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of a combined DASH dietary program and a home-based exercise regimen on patients with peripheral artery disease (PAD). Over three months, participants will be randomly assigned to either the combined intervention or a home-based exercise program alone. The study aims to measure improvements in walking distance, physical function quality of life, microvascular function, and inflammation markers. The hypothesis is that the combined approach will yield greater benefits than exercise alone.
Who should consider this trial
Good fit: Ideal candidates are individuals with a history of claudication and a confirmed diagnosis of peripheral artery disease.
Not a fit: Patients without peripheral artery disease or those with severe complications such as rest pain or tissue loss due to PAD may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the quality of life and physical capabilities of patients with peripheral artery disease.
How similar studies have performed: Other studies have shown promising results with dietary and exercise interventions for similar conditions, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. History of claudication, 2. Presence of PAD, defined by meeting at least one of the following criteria (ABI at rest \< 0.90, or \> 20% decrease in ABI following a heel-rise exercise test in patients with a normal ABI at rest (\> 0.90), or history of peripheral revascularization. Exclusion Criteria: 1. absence of PAD, defined by meeting all of the following 3 criteria (ABI at rest \> 0.90), \< 20% decrease in ABI following a heel-rise exercise test, and no history of peripheral revascularization, 2. non-compressible vessels (ABI \> 1.40), 3. rest pain due to PAD (Fontaine stage III; Rutherford Grade II), 4. tissue loss due to PAD (Fontaine stage IV; Rutherford Grade III), 5. use of medications indicated for the treatment of intermittent claudication (cilostazol and pentoxifylline) initiated within three months prior to investigation, 6. peripheral revascularization within one month prior to investigation, 7. active cancer, 8. end stage renal disease defined as stage 5 chronic kidney disease, 9. medical conditions that are contraindicative for exercise according to the American College of Sports Medicine, 10. cognitive dysfunction (mini-mental state examination score \< 24), and 11. failure to complete the baseline tests within three weeks.
Where this trial is running
Oklahoma City, Oklahoma
- O'Donoghue Research Building, University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States (Recruiting)
Study contacts
- Principal investigator: Andrew Gardner, Ph.D. — Professor, Department of Medicine, Cardiology
- Study coordinator: Andrew Gardner, Ph.D.
- Email: andrew-gardner@ouhsc.edu
- Phone: 405-271-4742
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.