Effect of Preoperative Exercise on Postoperative Outcome in AAA Patients: Pilot Study

Not Applicable

Completed

• Conditions: Surgery; Aortic Aneurysm, Abdominal
• Interventions: Other: Preoperative exercise

• Registration Number: NCT02845167
• Lead Sponsor: Medway NHS Foundation Trust

Brief Summary

Basic animal research has demonstrated that exercise training can protect the myocardium from ischemia-reperfusion injury through several biological mechanisms . This effect of exercise training may be beneficial in the perioperative period when cardiac complications may arise. However, exercise induced cardioprotection is lost completely within 18 days of stopping the training program. This finding from animal research will be used to test the hypothesis that 3 days of consecutive exercise with the last bout conducted within the last 24/48 hours prior to surgery, will have a cardioprotective effect . Specifically, exercise has been shown to protect cardiac myocytes against reperfusion induced oxidative stress and mitochondria against reperfusion induced damage. This exercise mediated cardioprotection is observed in short moderate duration ischemia (i.e. 5-20 min) and moderate to severe (i.e.20-60 min) ischemic insults. The effects of exercise induced cardioprotection have only been investigated at cell level and it has not been shown whether this will translate into a reduction in postsurgical reperfusion injury and associated complications. To study this potential cardioprotective effect the investigators will aim to recruit patients who have a high risk of receiving reperfusion injury during surgery. Specifically, the investigators will recruit abdominal aortic aneurysm patients where the risk of heart complications is high. There is also currently no evidence in the published literature with regard to the effect of preoperative supervised exercise.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2016-07
• Study First Submitted: 2016-07-17
• Study First Submitted QC: 2016-07-22
• Last Update Submitted: 2016-07-22
• Study First Posted: 2016-07-27
• Last Update Posted: 2016-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• Patients aged >18 years of age.
• Patients able to give informed consent.
• Able to comply with the study protocol
• Patients undergoing open repair for an asymptomatic perirenal and infrarenal abdominal aortic aneurysm

Exclusion Criteria

• Patients with severe disabling disorders limiting mobility, e.g. severe osteoarthritis
• Patients undergoing thoracoabdominal aneurysm surgery
• Patients physically unable or unwilling to undertake maximal cardiopulmonary exercise testing and the other fitness tests
• Patients younger than 18 years of age.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Preoperative exercise	Preoperative exercise	Patients will perform 3 consecutive days of 60 min submaximal cycling exercise at a moderate exercise intensity. During the 60 min of exercise, patients will be provided with three equally spaced 3min rest periods.

Primary Outcome Measures

Name	Time	Method
Length of in-hospital stay	Through study completion, on average up to 60 days post-surgery

Secondary Outcome Measures

Name	Time	Method
Postoperative mortality	60 day mortality
Postoperative in-hospital complications	On average up to 5 days post-surgery