Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00349947
Status:
COMPLETED
Last Update Posted:
2013-06-07
First Post:
2006-07-06
Brief Title:
Exercise Therapy to Treat Adults With Abdominal Aortic Aneurysms
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Abdominal Aortic Aneurysms Simple Treatment or Prevention AAA STOP
Status:
COMPLETED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AAASTOP
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 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P50HL083800-01 | NIH | None | httpsreporternihgovquickSearchP50HL083800-01 |
| 5P50HL083800 | NIH | None | None |