Effectiveness of Group Walking Sessions for Increasing Activity in People With Peripheral Arterial Disease (The Group Oriented Arterial Leg Study [GOALS])

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.