Ignite Creation Date:
2024-05-05 @ 11:00 PM
Last Modification Date:
2024-10-26 @ 10:27 AM
Study NCT ID:
NCT01234610
Status:
COMPLETED
Last Update Posted:
2017-12-20
First Post:
2010-11-03
Brief Title:
Feasibility Study of Exercise Training for Abdominal Aortic Aneurysm Disease
Sponsor:
Sheffield Teaching Hospitals NHS Foundation Trust
Organization:
Sheffield Teaching Hospitals NHS Foundation Trust
Study Overview
Official Title:
Exercise Therapy for Abdominal Aortic Aneurysm Disease a Feasibility Study
Status:
COMPLETED
Status Verified Date:
2017-12
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:
None
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 Large AAAs 55 mm diameter carry a high risk of rupture a surgical emergency that often leads to death due to severe internal bleeding It has been suggested that regular exercise training might limit the rate at which AAAs develop However little is known about the safety and effectiveness of exercise training in these patients This pilot study will examine the feasibility of supervised aerobic exercise training for patients with small AAAs 30 to 49 mm diameter The investigators hypothesize that exercise training will be safe and useful for patients with small AAAs
Detailed Description:
Abdominal aortic aneurysm AAA disease is a potentially lethal health problem of older adults New screening initiatives will identify many individuals with small 30 to 49 mm AAAs for which there are currently no treatment options Regular aerobic exercise might retard AAA disease progression but the feasibility and acceptability of aerobic exercise in patients with AAA disease has yet to be established This pilot study will examine the feasibility of supervised aerobic exercise and exercise advice-only in patients with small AAAs A total of 60 volunteers will be recruited and randomly allocated to one of the two groups Patients in the supervised exercise programme will be offered three supervised cycle ergometrytreadmill-walking sessions for a period of 12 weeks The feasibility of each intervention will be assessed in terms of recruitment and compliance attrition changes in cardiopulmonary fitness and objective measures of free-living physical activity Changes in aneurysm size and blood markers associated with disease progression will also be monitored and the impact of the interventions on health-related quality of life assessed using a questionnaire Outcomes will be assessed at baseline and 12 weeks We will also conduct focus groups at the end of the trial to obtain qualitative feedback from patients The results of this study will inform the design of a multi-centre randomised controlled trial with longer-term follow-up of clinical end-points
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