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

NCT00693940 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 194

Last updated 2015-10-29

No results posted yet for this study

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 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.

Conditions

Interventions

BEHAVIORAL

Group mediated cognitive behavioral (GMCB) sessions

GMCB will include weekly group exercise sessions, lasting approximately 60 to 75 minutes each for a 6 month period. During these 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. After completing the GMCB sessions, which will last about 6 months, participants will be telephoned regularly by a study coordinator for another 6 months.

OTHER

Health education sessions

Health education will include weekly educational sessions on a health-related topic, lasting approximately 60 minutes each. After completing the health education sessions, which will last about 6 months, participants will be telephoned regularly by a study coordinator for another 6 months.

Sponsors & Collaborators

Principal Investigators

  • Mary M. McDermott, MD · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2012-12-31
Completion
2013-05-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00693940 on ClinicalTrials.gov