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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
Medway NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Aneurysm, Abdominal

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    July 17, 2016
    Last Updated
    July 22, 2016
    Sponsor
    Medway NHS Foundation Trust
    Collaborators
    University of Kent
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    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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