Effectiveness of Group Walking Sessions for Increasing Activity in People With Peripheral Arterial Disease (The Group Oriented Arterial Leg Study [GOALS])
Effectiveness of Group Walking Sessions for Increasing Activity in People With Peripheral Arterial Disease (The Group Oriented Arterial Leg Study [GOALS])
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 while walking, which is caused by reduced blood flow to the legs. Regular
 walking has significant benefits for people with blood flow problems in their legs, but
 previous studies have shown that most men and women with PAD do not walk for exercise on a
 regular basis. A group home-based walking program may help people with PAD to walk more often
 and improve their lower extremity functioning. This study will evaluate the effectiveness of
 a home-based group mediated cognitive behavioral (GMCB) exercise program in helping people
 with lower extremity PAD to increase their walking frequency and improve their lower leg
 functioning.
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 cholesterol, or heart disease. PAD symptoms may include leg pain, foot or toe
 wounds, and a noticeably lower temperature in the lower legs than in the rest of the body.
 The specific functional impairments caused by PAD symptoms are associated with increased
 risks of disability, nursing home placement, mobility loss, hospitalization, and mortality.
 Supervised exercise rehabilitation programs have been shown to improve walking ability in
 people with PAD. However, few people with PAD have access to supervised exercise
 rehabilitation programs because of costs and difficulty traveling to the exercise facility.
 Home-based exercise programs may be more beneficial than supervised programs in improving
 lower extremity functioning in people with PAD, but more information is needed to support the
 effectiveness of at-home rehabilitation. This study will compare the effectiveness of a
 home-based GMCB exercise program versus general health education sessions in helping people
 with lower extremity PAD to increase their walking frequency and improve their lower leg
 functioning.

 Participation in this study will last 12 months. The primary outcome will be measured at 6
 month follow-up. All participants will undergo a baseline 6-minute walk test on a treadmill
 and an electrocardiogram (ECG). They will also provide information on their physical activity
 levels. Participants will then be assigned randomly to receive GMCB sessions or health
 education sessions. Both groups will attend weekly sessions of their assigned treatment for a
 6 month period. During the GMCB sessions, participants will be asked to exercise by walking
 around a track. There will also be a group discussion, led by a facilitator, who will help
 participants find ways to increase the frequency of their walking exercise at home. Each GMCB
 session will last approximately 60 to 75 minutes. Health education sessions will last 60
 minutes and will cover health-related topics.

 After completing approximately 6 months of treatment, participants in both groups will be
 telephoned regularly by a study coordinator: they will receive telephone calls every other
 week during Months 6 to 9 of follow-up and monthly during Months 9 to 12 of follow-up.
 Participants will be asked to return for follow-up testing at Month 6 and Month 12; outcomes
 measured at Month 6 are highest priority.
Inclusion Criteria:

 -  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 Criteria:

 -  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.