Exercise Therapy to Treat Adults With Abdominal Aortic Aneurysms (AAA:STOP)

• ClinicalTrials.gov Identifier: NCT00349947
• Recruitment Status: Completed
• First Posted: July 10, 2006
• Last Update Posted: June 7, 2013
• Sponsor: Stanford University
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by (Responsible Party): Stanford University

Study Description

Brief Summary:

An abdominal aortic aneurysm (AAA) is a weakened and enlarged area in the abdominal aorta, which is a large blood vessel in the abdomen. If an AAA ruptures, it can be life-threatening. Research has shown that sedentary individuals are at increased risk of developing AAAs. This study will evaluate the effectiveness of an exercise program at limiting the growth of small AAAs in older individuals.

Condition or disease	Intervention/treatment	Phase
Aortic Aneurysm, Abdominal	Behavioral: Exercise Program	Phase 1

Detailed Description:

AAAs are common among older individuals, and are the 10th leading cause of death for men over the age of 55. A ruptured AAA usually leads to death. Therefore, early detection and treatment are critical. Currently, there are several surgical treatment options available, but there is no proven non-surgical treatment for AAAs. Research has shown that physical inactivity may be linked to the development of AAAs. The purpose of this study is to gather information on AAA risk factors, and to evaluate the effectiveness of an exercise program at preventing the growth of small AAAs in older individuals.

This study will be composed of three individual projects. Project 1 will enroll 1400 individuals with small AAAs. Project 2 will enroll 1000 individuals with unknown aortic size and previously tested exercise capacity. Both groups of participants will attend one study visit, at which time their medical history and physical activity history will be recorded, vital signs will be collected, and blood and urine sample will be given. Questionnaires will be completed to document physical activity levels and AAA risk factors. An abdominal ultrasound will be performed to measure the size of the aorta or AAA. Participants in Project 2 will also take part in a treadmill exercise test, during which heart rate and blood pressure will be recorded, and heart activity will be monitored by an electrocardiogram (ECG).

The third project will last 3 years and will enroll 340 individuals from Project 1. Participants will be randomly assigned to either an exercise program or a usual activity group. An initial screening visit will include medical history review, vital sign measurements, blood collection, questionnaires, an abdominal ultrasound, a positron emission tomography (PET) scan, a computed tomography (CT) scan, and a magnetic resonance imaging (MRI) scan.

Participants in the exercise program will complete an exercise test at the beginning of the study and every 6 months for the duration of the study. Participants who live within 15 miles of the Palo Alto VA Hospital will take part in a supervised aerobic exercise program 3 days a week. Participants who live farther than 15 miles from the hospital will receive a detailed exercise plan and will exercise on their own while wearing a heart rate and activity tracking device. They will also attend monthly study visits for review of their progress. All participants assigned to the exercise program will be encouraged to increase their daily exercise. Each day they will wear a pedometer; twice a month they will wear a global positioning system (GPS) and heart rate monitor. Participants assigned to the usual activity group will wear pedometers each day and will maintain their usual level of physical activity. At yearly study visits, blood will be collected and physical activity levels will be assessed.

All Project 3 participants with AAAs smaller than 4 cm will undergo an ultrasound and blood collection once a year; participants with AAAs 4 cm or larger will undergo the same procedures every 6 months. At the end of 3 years, all participants will attend a final study visit at which time their medical history will be reviewed and blood will be collected. They will also undergo an abdominal ultrasound, and PET, CT, and MRI scans.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 2400 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Abdominal Aortic Aneurysms: Simple Treatment or Prevention (AAA: STOP)
• Study Start Date: November 2006
• Actual Primary Completion Date: April 2011
• Actual Study Completion Date: April 2011

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 1; Participants will take part in an exercise program.	Behavioral: Exercise Program; Participants who live within 15 miles of the Palo Alto VA Hospital will take part in a supervised aerobic exercise program 3 days a week. Participants who live farther than 15 miles from the hospital will receive a detailed exercise plan and will exercise on their own while wearing a heart rate and activity tracking device. They will also attend monthly study visits for review of their progress. All participants assigned to the exercise program will be encouraged to increase their daily exercise. Each day they will wear a pedometer; twice a month they will wear a global positioning system (GPS) and heart rate monitor.
No Intervention: 2; Participants will take part in a usual activity group.

Outcome Measures

Primary Outcome Measures :

1. Growth rate of AAAs [ Time Frame: Measured at Year 3 ]

Eligibility Criteria

• Ages Eligible for Study: 50 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Small AAA less than 5.5 cm in size
• Over age 50

Exclusion Criteria:

• Patients with congenital aneurysm syndromes such as Ehlers-Danlos' or Marfan's

Contacts and Locations

Locations

United States, California

Palo Alto Veterans Affairs Health Care System

Palo Alto, California, United States

Kaiser Permanente Hospitals of Northern California

Santa Clara, California, United States

Stanford University Medical Center

Stanford, California, United States, 94305

Sponsors and Collaborators

Stanford University

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Ronald L. Dalman, MD; Stanford University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Vainshelboim B, Rao S, Chan K, Lima RM, Ashley EA, Myers J. A comparison of methods for determining the ventilatory threshold: implications for surgical risk stratification. Can J Anaesth. 2017 Jun;64(6):634-642. doi: 10.1007/s12630-017-0862-8. Epub 2017 Apr 5.

Bianchi VE, Herbert WG, Myers J, Ribisl PM, Miller LE, Dalman RL. Relationship of obstructive sleep apnea and cardiometabolic risk factors in elderly patients with abdominal aortic aneurysm. Sleep Breath. 2015 May;19(2):593-8. doi: 10.1007/s11325-014-1053-2. Epub 2014 Sep 10.

Betz HH, Myers J, Jaffe A, Smith K, Dalman R. Reproducibility of the Veterans Physical Activity Questionnaire in an elderly population. J Phys Act Health. 2015 Mar;12(3):376-81. doi: 10.1123/jpah.2013-0124. Epub 2014 Apr 17.

Myers J, McElrath M, Jaffe A, Smith K, Fonda H, Vu A, Hill B, Dalman R. A randomized trial of exercise training in abdominal aortic aneurysm disease. Med Sci Sports Exerc. 2014 Jan;46(1):2-9. doi: 10.1249/MSS.0b013e3182a088b8.

Myers J, Dupain M, Vu A, Jaffe A, Smith K, Fonda H, Dalman R. Agreement between activity-monitoring devices during home rehabilitation: a substudy of the AAA STOP trial. J Aging Phys Act. 2014 Jan;22(1):87-95. doi: 10.1123/japa.2012-0133. Epub 2013 Feb 14.

• Responsible Party: Stanford University
• ClinicalTrials.gov Identifier: NCT00349947
• Other Study ID Numbers: 391; 5P50HL083800 ( U.S. NIH Grant/Contract ); P50HL083800-01 ( U.S. NIH Grant/Contract )
• First Posted: July 10, 2006
• Last Update Posted: June 7, 2013
• Last Verified: June 2013

Additional relevant MeSH terms:

Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases