Clinical Trial: Exercise Therapy to Treat Adults With Abdominal Aortic Aneurysms

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Abdominal Aortic Aneurysms: Simple Treatment or Prevention (AAA: STOP)

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.

Detailed Summary:

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 (M
Sponsor: Stanford University

Current Primary Outcome: Growth rate of AAAs [ Time Frame: Measured at Year 3 ]

Original Primary Outcome: Growth rate of AAAs (measured at Year 3)

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Stanford University

Dates:
Date Received: July 6, 2006
Date Started: November 2006
Date Completion:
Last Updated: June 5, 2013
Last Verified: June 2013