Status:
RECRUITING
The Effects of Diet and Exercise Interventions in Peripheral Artery Disease
Lead Sponsor:
University of Oklahoma
Collaborating Sponsors:
Milton S. Hershey Medical Center
National Institute on Aging (NIA)
Conditions:
Claudication
Peripheral Artery Disease
Eligibility:
All Genders
60+ years
Phase:
NA
Brief Summary
This study is a 3-month, prospective, randomized controlled clinical trial designed to address the efficacy of the DASH dietary program combined with a home-based exercise program, quantified by a ste...
Detailed 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...
Eligibility Criteria
Inclusion
- History of claudication,
- 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
- 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,
- non-compressible vessels (ABI \> 1.40),
- rest pain due to PAD (Fontaine stage III; Rutherford Grade II),
- tissue loss due to PAD (Fontaine stage IV; Rutherford Grade III),
- use of medications indicated for the treatment of intermittent claudication (cilostazol and pentoxifylline) initiated within three months prior to investigation,
- peripheral revascularization within one month prior to investigation,
- active cancer,
- end stage renal disease defined as stage 5 chronic kidney disease,
- medical conditions that are contraindicative for exercise according to the American College of Sports Medicine,
- cognitive dysfunction (mini-mental state examination score \< 24), and
- failure to complete the baseline tests within three weeks.
Key Trial Info
Start Date :
September 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2029
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT03845036
Start Date
September 16 2024
End Date
May 31 2029
Last Update
April 16 2025
Active Locations (1)
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1
O'Donoghue Research Building, University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73117