Viewing Study NCT03985202



Ignite Creation Date: 2024-05-06 @ 1:18 PM
Last Modification Date: 2024-10-26 @ 1:12 PM
Study NCT ID: NCT03985202
Status: UNKNOWN
Last Update Posted: 2022-07-26
First Post: 2019-06-04

Brief Title: Structured Exercise Programme and Abdominal Aortic Aneurysm Surgery
Sponsor: Torbay and South Devon NHS Foundation Trust
Organization: Torbay and South Devon NHS Foundation Trust

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 patients 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 55 cm they are referred to a Vascular Surgeon If the patients abdominal aorta is between 3 cm and 54 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 54 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 45 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: 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