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

NCT ID: NCT02845167

Last Updated: 2016-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2015-05-31

Brief Summary

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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

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Conditions

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Aortic Aneurysm, Abdominal Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Usual-care only

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Preoperative exercise

Intervention Type 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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Kent

OTHER

Sponsor Role collaborator

Medway NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Katharine Richardson

Dr Katharine Richardson

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Katharine Richardson

Role: PRINCIPAL_INVESTIGATOR

Medway Maritime NHS

References

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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.

Reference Type BACKGROUND
PMID: 18191755 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 6340579 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15450112 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11641363 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16860886 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14672968 (View on PubMed)

Other Identifiers

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11/LO/1472

Identifier Type: -

Identifier Source: org_study_id

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