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

NCT02845167 | Completed

• 1 other identifier: 11/LO/1472
• Study Type: interventional
• Target: 21
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Aortic Aneurysm, Abdominal; Surgery

Outcome Measures

Primary Outcomes (1)

• Length of in-hospital stay

  Through study completion, on average up to 60 days post-surgery

Secondary Outcomes (2)

• Postoperative mortality

  60 day mortality

• Postoperative in-hospital complications

  On average up to 5 days post-surgery

Study Arms (2)

Usual-care only

NO INTERVENTION

Patients will receive usual-care only during the preoperative period.

Preoperative exercise

EXPERIMENTAL

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.

Other: Preoperative exercise

Interventions

Preoperative exercise OTHER

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

Preoperative exercise

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medway NHS Foundation Trust: lead
• University of Kent: collaborator

Related Publications (6)

• 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.

  PMID: 18191755 BACKGROUND

• Goldman L. Cardiac risks and complications of noncardiac surgery. Ann Intern Med. 1983 Apr;98(4):504-13. doi: 10.7326/0003-4819-98-4-504.

  PMID: 6340579 BACKGROUND

• 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. doi: 10.1111/j.1365-201X.2004.01346.x.

  PMID: 15450112 BACKGROUND

• 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. doi: 10.1152/jappl.2001.91.5.2205.

  PMID: 11641363 BACKGROUND

• Ascensao A, Ferreira R, Magalhaes 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. doi: 10.1016/j.ijcard.2006.04.076. Epub 2006 Jul 24.

  PMID: 16860886 BACKGROUND

• 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. doi: 10.1152/japplphysiol.00920.2003. Epub 2003 Dec 12.

  PMID: 14672968 BACKGROUND

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Interventions

Preoperative Exercise

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Katharine Richardson

  Medway Maritime NHS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Katharine Richardson

Study Record Dates

• First Submitted: July 17, 2016
• First Posted: July 27, 2016
• Study Start: September 1, 2011
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: July 27, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share