Effect of Preoperative Exercise on Postoperative Outcome in AAA Patients: Pilot Study
Primary Purpose
Aortic Aneurysm, Abdominal, Surgery
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Preoperative exercise
Sponsored by
About this trial
This is an interventional treatment trial for Aortic Aneurysm, Abdominal
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Usual-care only
Preoperative exercise
Arm Description
Patients will receive usual-care only during the preoperative period.
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.
Outcomes
Primary Outcome Measures
Length of in-hospital stay
Secondary Outcome Measures
Postoperative mortality
Postoperative in-hospital complications
Full Information
NCT ID
NCT02845167
First Posted
July 17, 2016
Last Updated
July 22, 2016
Sponsor
Medway NHS Foundation Trust
Collaborators
University of Kent
1. Study Identification
Unique Protocol Identification Number
NCT02845167
Brief Title
Effect of Preoperative Exercise on Postoperative Outcome in AAA Patients: Pilot Study
Official Title
The Effect of Preoperative Exercise on Postoperative Outcome in AAA Patients: Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medway NHS Foundation Trust
Collaborators
University of Kent
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Aneurysm, Abdominal, Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual-care only
Arm Type
No Intervention
Arm Description
Patients will receive usual-care only during the preoperative period.
Arm Title
Preoperative exercise
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
Preoperative exercise
Intervention Description
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 Measure Information:
Title
Length of in-hospital stay
Time Frame
Through study completion, on average up to 60 days post-surgery
Secondary Outcome Measure Information:
Title
Postoperative mortality
Time Frame
60 day mortality
Title
Postoperative in-hospital complications
Time Frame
On average up to 5 days post-surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katharine Richardson
Organizational Affiliation
Medway Maritime NHS
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
18191755
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.
Results Reference
background
PubMed Identifier
6340579
Citation
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.
Results Reference
background
PubMed Identifier
15450112
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. doi: 10.1111/j.1365-201X.2004.01346.x.
Results Reference
background
PubMed Identifier
11641363
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. doi: 10.1152/jappl.2001.91.5.2205.
Results Reference
background
PubMed Identifier
16860886
Citation
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.
Results Reference
background
PubMed Identifier
14672968
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. doi: 10.1152/japplphysiol.00920.2003. Epub 2003 Dec 12.
Results Reference
background
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Effect of Preoperative Exercise on Postoperative Outcome in AAA Patients: Pilot Study
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