Ignite Creation Date:
2024-05-06 @ 9:29 AM
Last Modification Date:
2024-10-26 @ 12:15 PM
Study NCT ID:
NCT02997618
Status:
UNKNOWN
Last Update Posted:
2018-10-17
First Post:
2016-12-15
Brief Title:
The AAA Get Fit Trial A Pilot Randomised Controlled Trial of Community Based Exercise in Patients With Abdominal Aortic Aneurysms
Sponsor:
University of Manchester
Organization:
University of Manchester
Study Overview
Official Title:
The AAA Get Fit Trial A Pilot Randomised Controlled Trial of Community Based Exercise to Improve Fitness and Reduce Morbidity and Mortality of Patients With Abdominal Aortic Aneurysms
Status:
UNKNOWN
Status Verified Date:
2018-10
Last Known Status:
NOT_YET_RECRUITING
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:
Rupture of abdominal aortic aneurysmsAAA causes 12000 deathsyear in the UK1 Elective repair to prevent this carries a perioperative mortality of 45 for open surgery and 1 for endovascular repair This risk is associated with poor cardiorespiratory fitness which can be measured using Cardiopulmonary Exercise TestingCPET with the CPET variables peak oxygen uptakepeakVO215mlkgmin and anaerobic thresholdAT102mlkgmin identifying patients at increased risk of early death after AAA repair3 These variables can therefore be used as surrogate markers for cardiovascular fitness and risk of mortality and morbidity in AAA surgery optimising these markers should improve fitness and decrease this risk The optimal duration and type of exercise training for improving peak VO2 and AT in AAA patients is not known AAA patients are unique as they are motivated to reduce the risk of impending surgery but are afforded the time to improve their fitness as repair may not be needed for months or even years
The investigators propose a pilot randomised controlled trial to explore the effectiveness of a 20-week community either home or gym-based exercise programme to achieve sustained improvements in peak VO2 and AT as measured by CPET in AAA patients Changes in QoL habitual activity levels and cardiovascular risk will also be assessed The results will inform a definitive multicentre clinical trial on exercise to improve outcomes in elderly patients with cardiovascular disease and AAA
The investigators propose a pilot randomised controlled trial to explore the effectiveness of a 20-week community either home or gym-based exercise programme to achieve sustained improvements in peak VO2 and AT as measured by CPET in AAA patients Changes in QoL habitual activity levels and cardiovascular risk will also be assessed The results will inform a definitive multicentre clinical trial on exercise to improve outcomes in elderly patients with cardiovascular disease and AAA
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None