Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:55 AM
Study NCT ID:
NCT03985202
Status:
UNKNOWN
Last Update Posted:
2022-07-26
First Post:
2019-06-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Structured Exercise Programme and Abdominal Aortic Aneurysm Surgery
Sponsor:
Torbay and South Devon NHS Foundation Trust
Organization:
Study Overview
Official Title:
Can a Structured Exercise Programme Improve the Predicted Survival for Planned Abdominal Aortic Aneurysm Surgery Patients?
Status:
UNKNOWN
Status Verified Date:
2022-07
Last Known Status:
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:
There is a relationship between aerobic fitness and survival both with and without surgery. Some patients can improve their aerobic fitness with a structured exercise programme but currently it is not know how much this could change predicted survival for patients with an abdominal aortic aneurysm, or how long this change can be maintained. Survival can be predicted after planned abdominal aortic aneurysm (AAA) surgery using physical fitness measured with a cardiopulmonary exercise test. The researchers have validated this in a published peer reviewed multicentre study. In this study the patient's fitness will be measured before and after a structured exercise programme and assess if there is any change in their predicted survival. The primary objective of the study is to measure the change in predicted survival for abdominal aortic aneurysm surgery after a structured exercise programme. In addition the patients are asked to complete the following questionnaires:- EQ-5D-5L, Hospital Anxiety and Depression Scale (HADS) before and after the exercise programme.
Detailed Description:
The UK has a national AAA screening programme. At the age of 65 men are offered a one off ultrasound test to look for a AAA. If their abdominal aorta is \> 5.5 cm they are referred to a Vascular Surgeon. If the patients abdominal aorta is between 3 cm and 5.4 cm they are offered further ultrasound scans to monitor the size of their aorta. This is a surveillance programme. In addition men who have an AAA between 3 cm and 5.4 cm that is detected by an ultrasound scan, CT or MRI performed as part of an investigation for another clinical problem are added to the surveillance programme.
In Torbay and South Devon men in the AAA surveillance programme are referred for a Cardiopulmonary Exercise Test when the AAA reaches 4.5 cm as part of standard clinical practice. This takes place in the Pre assessment Clinic in Torbay Hospital and is performed by a Consultant Anaesthetist. If the patient is able to safely perform the Cardiopulmonary Exercise Test they will be identified as potential participants by the Consultant Anaesthetist.
In Torbay and South Devon men in the AAA surveillance programme are referred for a Cardiopulmonary Exercise Test when the AAA reaches 4.5 cm as part of standard clinical practice. This takes place in the Pre assessment Clinic in Torbay Hospital and is performed by a Consultant Anaesthetist. If the patient is able to safely perform the Cardiopulmonary Exercise Test they will be identified as potential participants by the Consultant Anaesthetist.
Study Oversight
Has Oversight DMC:
False
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?: