Aortic Aneurysm, AbdominalNCT02845167
Effect of Preoperative Exercise on Postoperative Outcome in AAA Patients: Pilot Study
A study testing Preoperative exercise in people with Aortic Aneurysm, Abdominal and Surgery, run by Medway NHS Foundation Trust.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Aortic Aneurysm, Abdominal, Surgery
- What is being tested?
- Preoperative exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- Sep 2011to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: The Effect of Preoperative Exercise on Postoperative Outcome in AAA Patients: Pilot Study
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
- Being tested
- Preoperative exercise
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative exerciseOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Preoperative exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of in-hospital stay
Measured: Through study completion, on average up to 60 days post-surgery
Secondary outcomes (2)
Postoperative mortality
Measured: 60 day mortality
Postoperative in-hospital complications
Measured: On average up to 5 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study startSep 2011
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Aortic Aneurysm, AbdominalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medway NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kent
- Responsible party
- Principal investigator, Katharine Richardson, Medway NHS Foundation Trust
- Investigators
- Katharine Richardson, Principal investigator, Medway Maritime NHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02845167
- Sponsor's protocol ID
- 11/LO/1472
- Status last verified
- Jul 2016
- First submitted
- 17 Jul 2016
- Last updated
- 27 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 18191755Goldman 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.
PubMed 6340579Lennon 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.
PubMed 15450112Demirel 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.
PubMed 11641363Ascensao 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.
PubMed 16860886Lennon 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.
PubMed 14672968
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Exercise on Postoperative Outcome in AAA Patients: Pilot Study
- ClinicalTrials.gov ID
- NCT02845167
- Acronym / sponsor ID
- 11/LO/1472
- Conditions
- Aortic Aneurysm, Abdominal, Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Medway NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Kent
- Study start
- Sep 2011
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 27 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual-care only | No intervention | –Patients will receive usual-care only during the preoperative period. |
| Preoperative exercise | Experimental | Other: Preoperative exercisePatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative exercisePatients 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 |
Primary outcome
Length of in-hospital stay
Time frame: Through study completion, on average up to 60 days post-surgery
2 secondary outcomes
Postoperative mortality
Time frame: 60 day mortality
Postoperative in-hospital complications
Time frame: On average up to 5 days post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2016.
- Background: PubMed 18191755Powers 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.
- Background: PubMed 6340579Goldman 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.
- Background: PubMed 15450112Lennon 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.
- Background: PubMed 11641363Demirel 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.
- Background: PubMed 16860886Ascensao 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.
- Background: PubMed 14672968Lennon 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katharine Richardson principal investigator
Medway Maritime NHS
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative exercise in people with Aortic Aneurysm, Abdominal and Surgery, run by Medway NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of in-hospital stay (time frame: Through study completion, on average up to 60 days post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02845167, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2016.