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Multifactor Risk Reduction for Optimal Management of PAD (VIGOR2)

Primary Purpose

Peripheral Arterial Disease

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

exercise

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring peripheral arterial disease, walking time, lifestyle modification, cardiovascular risk reduction, exercise, diet, claudication

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

A-Exercise group

B- Usual Care

Arm Description

Home based exercise

Exercise as usually prescribed by provider

Outcomes

Primary Outcome Measures

walking time

determined by symptom limited walking time on treadmill exercise test

Secondary Outcome Measures

quality of life, biomarkers of CVD risk, endothelial function

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

Full Information

NCT ID

NCT00537225

First Posted

September 27, 2007

Last Updated

April 17, 2023

Sponsor

Palo Alto Veterans Institute for Research

Collaborators

Stanford University, University of California, San Francisco

1. Study Identification

Unique Protocol Identification Number

NCT00537225

Brief Title

Multifactor Risk Reduction for Optimal Management of PAD

Acronym

VIGOR2

Official Title

Multifactor Risk Reduction for Optimal Management of PAD

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

September 2006 (Actual)

Primary Completion Date

June 2013 (Actual)

Study Completion Date

June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Palo Alto Veterans Institute for Research

Collaborators

Stanford University, University of California, San Francisco

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

Detailed Description

closed to recruitment

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Arterial Disease

Keywords

peripheral arterial disease, walking time, lifestyle modification, cardiovascular risk reduction, exercise, diet, claudication

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Home-based exercise

Masking

Participant

Allocation

Randomized

Enrollment

300 (Actual)

8. Arms, Groups, and Interventions

Arm Title

A-Exercise group

Arm Type

Experimental

Arm Description

Home based exercise

Arm Title

B- Usual Care

Arm Type

No Intervention

Arm Description

Exercise as usually prescribed by provider

Intervention Type

Behavioral

Intervention Name(s)

exercise

Intervention Description

tailored multifactor CVD risk reduction

Primary Outcome Measure Information:

Title

walking time

Description

determined by symptom limited walking time on treadmill exercise test

Time Frame

24 months

Secondary Outcome Measure Information:

Title

quality of life, biomarkers of CVD risk, endothelial function

Description

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

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Roberta K Oka, ANP, DNSc

Organizational Affiliation

PAIRE

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

22363015

Citation

Oka RK, Conte MS, Owens CD, Rapp J, Fung G, Alley HF, Giacomini JC, Myers J, Mohler ER 3rd. Efficacy of optimal long-term management of multiple cardiovascular risk factors (CVD) on walking and quality of life in patients with peripheral artery disease (PAD): protocol for randomized controlled trial. Vasc Med. 2012 Feb;17(1):17-28. doi: 10.1177/1358863X11430886.

Results Reference

background

PubMed Identifier

22901446

Citation

Oka RK, Alley HF. Differences in nutrition status by body mass index in patients with peripheral artery disease. J Vasc Nurs. 2012 Sep;30(3):77-87. doi: 10.1016/j.jvn.2012.04.003.

Results Reference

result

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Multifactor Risk Reduction for Optimal Management of PAD

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