Status:
COMPLETED
Effectiveness of Group Walking Sessions for Increasing Activity in People With Peripheral Arterial Disease (The Group Oriented Arterial Leg Study [GOALS])
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Peripheral Vascular Diseases
Cardiovascular Diseases
Eligibility:
All Genders
25+ years
Phase:
PHASE3
Brief Summary
Lower extremity peripheral arterial disease (PAD) is a disease in which fatty build-up, or plaque, accumulates in the arteries of the legs. People with lower extremity PAD often experience leg pain wh...
Detailed Description
Lower extremity PAD affects between 10% and 15% of people over the age of 65. A person's risk for PAD increases with age but can also be raised by smoking or having diabetes, high blood pressure, high...
Eligibility Criteria
Inclusion
- Have PAD
- Potential participants with a resting ABI greater than or equal to 0.91 and less than or equal to 1.00 at their baseline visit will be eligible if their ABI drops by at least 20% after the heel-rise test. Potential participants with a resting baseline ABI greater than 0.91 who do not meet criteria for inclusion based on the heel-rise test can be eligible if they have data from a certified non-invasive vascular laboratory that demonstrates presence of lower extremity ischemia. However, more evidence than an abnormal PVR from the non-invasive vascular laboratory is required (for example, a toe brachial index pressure less than 0.60). Finally, potential participants who do not meet the above criteria for inclusion will be eligible if they have an angiogram demonstrating greater than 50% stenosis on one or more lower extremity arterial vessels.
Exclusion
- Below or above knee amputation
- Wheelchair confinement
- Uses a walking aid other than a cane (e.g., walker)
- Unable to return to the medical center at the required visit frequency
- Greater than Class II New York Heart Association heart failure or angina (symptoms at rest or with minimal exertion)
- Any increase in angina pectoris symptoms during the 6 months before study entry or angina at rest
- Presence of a foot ulcer
- Lower extremity revascularization or major orthopedic surgery during the 3 months before study entry
- Heart attack or coronary artery bypass grafting during the 3 months before study entry
- Major medical illnesses, including treatment for cancer (except non-melanoma skin cancer) during the 12 months before study entry
- Planned lower extremity revascularization within the 12 months after study entry
- Current participation in another clinical trial
- Walking for exercise at a level comparable to that targeted in the study's intervention
- Completion of a cardiac rehabilitation program within 3 months before study entry
- Coronary ischemia during exercise, defined as ST segment depression greater than 1 mm during the baseline exercise treadmill test, with or without associated chest discomfort
- Left-bundle branch block or significant ST-T wave changes on the baseline ECG without a perfusion stress test, demonstrating no reversible ischemia within the 3 months before study entry
- Stopping during the treadmill exercise stress test because of chest pain, shortness of breath, hip or knee arthritis. These individuals will be interviewed by the principal investigator and will be excluded only if it is determined that their walking performance (based in part on the treadmill test) is limited by a comorbidity other than leg ischemia.
- Unable to walk at least 50 feet without stopping during the 6-minute walk test
- Stopping during the 6-minute walk test for symptoms other than ischemic leg symptoms
- Mini-Mental Status Examination (MMSE) score of less than 23 or psychiatric illness
- Failure to complete a study run-in period
- Parkinson's disease
- Requires oxygen with exertion.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
194 Patients enrolled
Trial Details
Trial ID
NCT00693940
Start Date
June 1 2008
End Date
May 1 2013
Last Update
October 29 2015
Active Locations (1)
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1
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611