NCT00349947

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,400

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2006

Longer than P75 for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 10, 2006

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2006

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

June 7, 2013

Status Verified

June 1, 2013

Enrollment Period

4.4 years

First QC Date

July 6, 2006

Last Update Submit

June 5, 2013

Conditions

Aortic Aneurysm, Abdominal

Outcome Measures

Primary Outcomes (1)

  • Growth rate of AAAs

    Measured at Year 3

Study Arms (2)

1

ACTIVE COMPARATOR

Participants will take part in an exercise program.

Behavioral: Exercise Program

2

NO INTERVENTION

Participants will take part in a usual activity group.

Interventions

Exercise ProgramBEHAVIORAL

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.

1

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Palo Alto Veterans Affairs Health Care System

Palo Alto, California, United States

Location

Kaiser Permanente Hospitals of Northern California

Santa Clara, California, United States

Location

Stanford University Medical Center

Stanford, California, 94305, United States

Location

Related Publications (5)

  • 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.

    PMID: 28382529DERIVED

  • 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.

    PMID: 25204854DERIVED

  • 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.

    PMID: 24763187DERIVED

  • 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.

    PMID: 23793234DERIVED

  • 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.

    PMID: 23416349DERIVED

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Ronald L. Dalman, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2006

First Posted

July 10, 2006

Study Start

November 1, 2006

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

June 7, 2013

Record last verified: 2013-06

Locations

US(3)