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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00693940
• Date of registration: 05/06/2008
• Primary sponsor: Northwestern University
• Public title: Effectiveness of Group Walking Sessions for Increasing Activity in People With Peripheral Arterial Disease (The Group Oriented Arterial Leg Study [GOALS])
• Scientific title: Increasing Activity in Peripheral Arterial Disease
• Date of first enrolment: June 2008
• Target sample size: 200
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00693940
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Mary M. McDermott, MD
• Affiliation: Northwestern University

Key inclusion & exclusion criteria

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.



Age minimum: 25 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Cardiovascular Diseases

Peripheral Vascular Diseases

Intervention(s)

Behavioral: Group mediated cognitive behavioral (GMCB) sessions

Other: Health education sessions

Primary Outcome(s)

6-minute walk test at 6 month follow-up [Time Frame: Measured at baseline and Month 6 follow-up]

Secondary Outcome(s)

6-minute walk test at Month 12 follow-up [Time Frame: Measured at Month 12 follow-up]

Health-related quality of life measures [Time Frame: Measured at baseline, Month 6, and Month 12 follow-up]

Physical activity levels [Time Frame: Measured at baseline, Month 6, and Month 12 follow-up]

Treadmill walking performance [Time Frame: Measured at baseline and Month 6 follow-up]

Secondary ID(s)

586

HL088589-01

R01HL088589-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Heart, Lung, and Blood Institute (NHLBI)