Peripheral Arterial DiseaseVIGOR2NCT00537225
Multifactor Risk Reduction for Optimal Management of PAD
A study testing exercise in people with Peripheral Arterial Disease, run by Palo Alto Veterans Institute for Research.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Sep 2006to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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%.
Who cannot join
- 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
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- 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.
About this study
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).
Read more
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.
Read the detailed description
closed to recruitment
- Conditions
- Peripheral Arterial Disease
- Being tested
- exercise
- Keywords
- peripheral arterial disease, walking time, lifestyle modification, cardiovascular risk reduction, exercise, diet, claudication
- Medical subject headings
- Peripheral Arterial Disease, Motor Activity, Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseBehavioural
tailored multifactor CVD risk reduction
| Study group | Role | What they receive |
|---|---|---|
| A-Exercise group | Experimental | Home based exercise Receives: Behavioral: exercise |
| B- Usual Care | No intervention | Exercise as usually prescribed by provider |
What is being measured
The primary outcome is the main question the study is designed to answer.
walking time
determined by symptom limited walking time on treadmill exercise test
Measured: 24 months
Secondary outcomes (1)
quality of life, biomarkers of CVD risk, endothelial function
Quality of life per SF-36; biomarkers include: lipids, endothelial function per FMD
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2007 (estimated)
- Study startSep 2006
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Home-based exercise
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Palo Alto Veterans Institute for Research
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University, University of California, San Francisco
- Responsible party
- Sponsor
- Investigators
- Roberta K Oka, ANP, DNSc, Principal investigator, PAIRE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00537225
- Sponsor's protocol ID
- OKR0001AGG/SGG
- Acronym
- VIGOR2
- Status last verified
- Apr 2023
- First submitted
- 27 Sep 2007
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 22363015Oka 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.
PubMed 22901446
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multifactor Risk Reduction for Optimal Management of PAD
- ClinicalTrials.gov ID
- NCT00537225
- Acronym / sponsor ID
- VIGOR2 / OKR0001AGG/SGG
- Conditions
- Peripheral Arterial Disease
- Keywords
- peripheral arterial disease, walking time, lifestyle modification, cardiovascular risk reduction, exercise, diet, claudication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Palo Alto Veterans Institute for ResearchUniversity, hospital or other
- Collaborators
- Stanford University, University of California, San Francisco
- Study start
- Sep 2006 (actual)
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 1 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Home-based exercise
| Arm | Type | Receives |
|---|---|---|
| A-Exercise group | Experimental | Behavioral: exerciseHome based exercise |
| B- Usual Care | No intervention | –Exercise as usually prescribed by provider |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercisetailored multifactor CVD risk reduction | Behavioural | A-Exercise group |
Primary outcome
walking time
Time frame: 24 months
determined by symptom limited walking time on treadmill exercise test
1 secondary outcome
quality of life, biomarkers of CVD risk, endothelial function
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
- Background: PubMed 22363015Oka 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 publication: PubMed 22901446Oka 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.
- Individual participant dataSharing planned: No
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Peripheral Arterial Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberta K Oka, ANP, DNSc principal investigator
PAIRE
Questions about this trial
What is this clinical trial studying?
A study testing exercise in people with Peripheral Arterial Disease, run by Palo Alto Veterans Institute for Research.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
walking time (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00537225, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2023.