Multifactor Risk Reduction for Optimal Management of PAD

Patients with peripheral arterial disease (PAD) experience significant functional limitations due to ischemic symptoms (claudication) and are at high risk for CVD morbidity and mortality resulting from untreated cardiovascular disease (CVD) risk factors and aggressive atherosclerosis. The overall Goal of this randomized controlled clinical trial is to examine the synergistic effect of a multifactor risk reduction on walking distance, blood flow and quality of life in 300 patients with PAD.

Specifically, we will compare the effects of 24 months of a novel, yet well-tested multiple risk factor reduction program, the Health Education and Risk Reduction Training (HEAR2T) Program for PAD versus enhanced standard care on: 1) symptom limited walking distance as assessed by treadmill exercise testing and walking impairment questionnaire; 2) endothelial function as measured by flow mediated vasodilation (FMVD) via brachial artery ultrasound. We will also explore the association between FMVD and decreased oxidative stress (as measured by oxygen radical absorbance capacity and urinary isoprostanes) and reduced degradation of nitric oxide (NO) and/or increased NO biosynthesis (as measured by urine nitrogen oxide, plasma nitrogen oxide, plasma asymmetric dimethylarginine, plasma, urine and platelet cyclic GMP).

Secondary hypotheses examine the association between reducing CVD risk factors, improved endothelial function, increased walking distance, improved quality of life and number of metabolic syndrome abnormalities in PAD patients.

Significance. This study will contribute to evidence on the efficacy of multiple risk factor reduction on improving physical function and quality of life in the understudied, elderly PAD patient. This study will also provide preliminary evidence for the biological basis for the efficacy of multifactor risk reduction in restoring vascular homeostasis, critical because of its role in antiatherogenesis and maintaining vasoreactivity, both necessary for slowing the progression of atherosclerosis.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Behavior Cardiovascular Diseases Intermittent Claudication Motor Activity Pathological Conditions, Signs and Symptoms Peripheral Vascular Diseases Signs and Symptoms Vascular Diseases

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

closed to recruitment

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects eligible for this study include:

Age 50 years or older with one or more CVD risk factor
PAD secondary to atherosclerosis with significant claudication
Claudication is defined as pain, ache, cramp, numbness or severe fatigue of muscles of one or both lower extremities, reproducibly provoked by walking causing the patient to slow or stop walking pace
Ankle-brachial index (ABI) < 0.90
In diabetics ABI is inaccurate, in which case, we will substitute toe pressures < 60 mmHg
ABI one minute after exercise is at least 20% lower than index leg resting ABI
Capable of walking at least 50 feet
Primary limitation to walking is claudication, not coexisting conditions such as severe CAD, uncontrolled hypertension, pulmonary disease, severe arthritis, or orthopedic conditions
Difference of walking time between two consecutive (of four) baseline treadmill tests must be < 25%.

Exclusion criteria

include:

Active malignancy or tumor or other condition that would severely limit life expectancy
Any type of major surgery during the last 3 months (i.e. aortic or lower extremity arterial surgery, angioplasty, or lumbar sympathectomy, leg amputation above the ankle)
Residence in a long-term institutional setting
Psychiatric disorders with currently active manifestations
Uncontrolled metabolic disorders (renal failure, liver failure, thyrotoxicosis)
Active symptoms suggestive of an acute coronary syndrome or decompensated heart failure
Lack of phone access (either by self or through neighbors/family members)
Other specified circumstances incompatible with case-management (i.e., plan to move away from area)
Presence of another household member or first-degree relative already enrolled in the study
Current enrollment in another clinical trial
Regular participation in an exercise program for at least 3 months prior to study entry.

Treatment and study plan

Exercise

Behavioral

tailored multifactor CVD risk reduction

Primary outcomes

walking time

Time frame: 24 months

determined by symptom limited walking time on treadmill exercise test

Secondary outcomes

quality of life, biomarkers of CVD risk, endothelial function

Time frame: 24 months

Quality of life per SF-36; biomarkers include: lipids, endothelial function per FMD

Sponsors and collaborators

Lead sponsor

Palo Alto Veterans Institute for Research

Other

Collaborators

Stanford University
University of California, San Francisco

Registry information

Acronym: VIGOR2

Important dates

Study start: 2006
Primary completion: 2013
Study completion: 2013
First posted: Oct 1, 2007
Registry last updated: Apr 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed