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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02845167
• Other study ID #: 11/LO/1472
• Status: Completed
• Phase: N/A
• First received: July 17, 2016
• Last updated: July 22, 2016
• Start date: September 2011
• Est. completion date: May 2015

Study information

• Verified date: July 2016
• Source: Medway NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Surgery

Intervention

Other:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Medway NHS Foundation Trust	University of Kent

References & Publications (6)

Ascensão A, Ferreira R, Magalhães J. Exercise-induced cardioprotection--biochemical, morphological and functional evidence in whole tissue and isolated mitochondria. Int J Cardiol. 2007 Apr 12;117(1):16-30. Epub 2006 Jul 24. Review. — View Citation

Demirel HA, Powers SK, Zergeroglu MA, Shanely RA, Hamilton K, Coombes J, Naito H. Short-term exercise improves myocardial tolerance to in vivo ischemia-reperfusion in the rat. J Appl Physiol (1985). 2001 Nov;91(5):2205-12. — View Citation

Goldman L. Cardiac risks and complications of noncardiac surgery. Ann Intern Med. 1983 Apr;98(4):504-13. Review. — View Citation

Lennon SL, Quindry J, Hamilton KL, French J, Staib J, Mehta JL, Powers SK. Loss of exercise-induced cardioprotection after cessation of exercise. J Appl Physiol (1985). 2004 Apr;96(4):1299-305. Epub 2003 Dec 12. — View Citation

Lennon SL, Quindry JC, French JP, Kim S, Mehta JL, Powers SK. Exercise and myocardial tolerance to ischaemia-reperfusion. Acta Physiol Scand. 2004 Oct;182(2):161-9. — View Citation

Powers SK, Quindry JC, Kavazis AN. Exercise-induced cardioprotection against myocardial ischemia-reperfusion injury. Free Radic Biol Med. 2008 Jan 15;44(2):193-201. doi: 10.1016/j.freeradbiomed.2007.02.006. Epub 2007 Feb 21. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of in-hospital stay		Through study completion, on average up to 60 days post-surgery	Yes
Secondary	Postoperative mortality		60 day mortality	Yes
Secondary	Postoperative in-hospital complications		On average up to 5 days post-surgery	Yes