Health TrialsbyHealthPanel

The Effects of Diet and Exercise Interventions in Peripheral Artery Disease

ConditionsClaudicationPeripheral Artery Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorUniversity of Oklahoma

About this trial

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 step activity monitor, to improve exercise and vascular outcome measures in patients with PAD.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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),

Trial design

Design model

Parallel

Treatments tested in this trial

  • DASH Diet plus Home-Based Exercise

    Behavioral

    The DASH dietary program consists of a diet emphasizing foods rich in fruits, vegetables, whole grains, and low-fat dairy, in which patients record daily servings of fruits and vegetables. The home-based exercise program consists of intermittent walking to moderate claudication pain 3 times per week for 3 months in a home-based setting.

  • Home-Based Exercise

    Behavioral

    The home-based exercise program consists of intermittent walking to moderate claudication pain 3 times per week for 3 months in a home-based setting.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: DASH Diet plus Home-Based ExerciseExperimental treatment 1 intervention
Group B: Home-Based ExerciseActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Peak Walking Time

The change in the time walked on a treadmill test

Time frame
3 months
2

Physical Function subscale of quality of life from the Medical Outcomes Study Short-Form 36 questionnaire

The change in the Physical Function subscale from the pre-test value to the post-test value

Time frame
3 months

Secondary outcomes

1

calf muscle oxygen saturation

The change in the calf muscle oxygen saturation value during exercise from the pre-test value to the post-test value

Time frame
3 months
2

6-minute walk distance

The change in 6-minute walk distance from the pre-test value to the post-test value

Time frame
3 months
3

high-sensitivity C-reactive protein

The change in the high-sensitivity C-reactive protein value from the pre-test value to the post-test value

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Oklahoma

Lead sponsor

Milton S. Hershey Medical Center

Collaborator

National Institute on Aging (NIA)

Collaborator

Case Western Reserve University

Collaborator

Source ClinicalTrials.gov
Apply now