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The Effects of a Novel, Non-ischemic and Pain-free Exercise Intervention 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 Non-Ischemic Exercise (NICE) program to improve exercise and vascular outcome measures in patients with peripheral artery disease (PAD).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

history of claudication assessed by the Walking Impairment Questionnaire,

ambulatory leg pain in either one or both legs consistent with intermittent claudication confirmed during a screening graded treadmill test using the Gardner-Skinner protocol,

an ABI <= 0.90 at rest or > 20% decrease in ankle systolic blood pressure in either one or both legs immediately following the treadmill exercise test.

age >= 40 years.

Disqualifiers

absence of PAD (ABI > 0.90 at rest and ankle systolic blood pressure < 20% decrease after exercise,

inability to obtain an ABI measure due to non-compressible vessels (ABI > 1.40),

asymptomatic PAD (Fontaine Stage I) determined from the medical history and verified during the graded treadmill test,

rest pain due to PAD (Fontaine stage III)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Exercise

    Behavioral

    Non-Ischemic Exercise (NICE), pain-free exercise program will be compared to the Standard painful exercise program.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Non-Ischemic Exercise (NICE) exercise programExperimental treatment 1 intervention
Group B: Standard exercise programActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Peak Walking Time

The change in peak walking time from the pre-test value to the post-test value (seconds)

Time frame
3 months
2

Calf Muscle Oxygen Saturation

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

Time frame
3 months

Secondary outcomes

1

6-Minute Walk Distance

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

Time frame
3 months
2

plasma C-Reactive Protein

The change in plasma C-reactive protein from the pre-test value to the post-test value (mg/L)

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

Case Western Reserve University

Collaborator

National Institute on Aging (NIA)

Collaborator

Source ClinicalTrials.gov
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