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

NCT00693940 | Completed Phase 3 DMC

• 3 other identifiers: 586R01HL088589-01HL088589-01
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 1

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 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

Peripheral Vascular Diseases; Cardiovascular Diseases

Keywords

Peripheral Arterial Disease; PAD

Outcome Measures

Primary Outcomes (1)

• 6-minute walk test at 6 month follow-up

  Measured at baseline and Month 6 follow-up

Secondary Outcomes (4)

• Treadmill walking performance

  Measured at baseline and Month 6 follow-up

• Health-related quality of life measures

  Measured at baseline, Month 6, and Month 12 follow-up

• Physical activity levels

  Measured at baseline, Month 6, and Month 12 follow-up

• 6-minute walk test at Month 12 follow-up

  Measured at Month 12 follow-up

Study Arms (2)

1

EXPERIMENTAL

Participants will receive treatment with group mediated cognitive behavioral sessions.

Behavioral: Group mediated cognitive behavioral (GMCB) sessions

2

ACTIVE COMPARATOR

Participants will receive treatment with health education sessions.

Other: Health education sessions

Interventions

Group mediated cognitive behavioral (GMCB) sessions BEHAVIORAL

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.

1

Health education sessions OTHER

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.

2

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have PAD

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Related Publications (5)

• Kosmac K, Gonzalez-Freire M, McDermott MM, White SH, Walton RG, Sufit RL, Tian L, Li L, Kibbe MR, Criqui MH, Guralnik JM, S Polonsky T, Leeuwenburgh C, Ferrucci L, Peterson CA. Correlations of Calf Muscle Macrophage Content With Muscle Properties and Walking Performance in Peripheral Artery Disease. J Am Heart Assoc. 2020 May 18;9(10):e015929. doi: 10.1161/JAHA.118.015929. Epub 2020 May 9.

  PMID: 32390569 DERIVED

• McDermott MM, Guralnik JM, Criqui MH, Ferrucci L, Liu K, Spring B, Tian L, Domanchuk K, Kibbe M, Zhao L, Lloyd Jones D, Liao Y, Gao Y, Rejeski WJ. Unsupervised exercise and mobility loss in peripheral artery disease: a randomized controlled trial. J Am Heart Assoc. 2015 May 20;4(5):e001659. doi: 10.1161/JAHA.114.001659.

  PMID: 25994445 DERIVED

• McDermott MM, Guralnik JM, Criqui MH, Ferrucci L, Zhao L, Liu K, Domanchuk K, Spring B, Tian L, Kibbe M, Liao Y, Lloyd Jones D, Rejeski WJ. Home-based walking exercise in peripheral artery disease: 12-month follow-up of the GOALS randomized trial. J Am Heart Assoc. 2014 May 21;3(3):e000711. doi: 10.1161/JAHA.113.000711.

  PMID: 24850615 DERIVED

• Rejeski WJ, Spring B, Domanchuk K, Tao H, Tian L, Zhao L, McDermott MM. A group-mediated, home-based physical activity intervention for patients with peripheral artery disease: effects on social and psychological function. J Transl Med. 2014 Jan 28;12:29. doi: 10.1186/1479-5876-12-29.

  PMID: 24467875 DERIVED

• McDermott MM, Liu K, Guralnik JM, Criqui MH, Spring B, Tian L, Domanchuk K, Ferrucci L, Lloyd-Jones D, Kibbe M, Tao H, Zhao L, Liao Y, Rejeski WJ. Home-based walking exercise intervention in peripheral artery disease: a randomized clinical trial. JAMA. 2013 Jul 3;310(1):57-65. doi: 10.1001/jama.2013.7231.

  PMID: 23821089 DERIVED

MeSH Terms

Conditions

Peripheral Vascular Diseases; Cardiovascular Diseases; Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Vascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Mary M. McDermott, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine and Preventive Medicine at Northwestern University Feinberg School of Medicine

Study Record Dates

• First Submitted: June 5, 2008
• First Posted: June 9, 2008
• Study Start: June 1, 2008
• Primary Completion: December 1, 2012
• Study Completion: May 1, 2013
• Last Updated: October 29, 2015

Record last verified: 2015-10

Locations

US (1)