Effect of Pre-operative Exercise in Abdominal Aortic Aneurysms (AAA) Patients.

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Disease Information

Descriptive Information
Brief Title † Effect of Pre-operative Exercise in Abdominal Aortic Aneurysms (AAA) Patients.
Official Title † A Randomised Controlled Trial to Assess the Effect of a Pre-operative Supervised Exercise Programme on Outcome Following Intervention for Abdominal Aortic Aneurysms.
Brief Summary An aneurysm is a permanent and localized dilatation of an artery usually more than 50% of its normal diameter. Abdominal Aortic Aneurysms (AAA) is an aneurysm of the main artery of abdomen and affects 5% of men aged 65-74 years. Rupture of an aneurysm is the 10th leading cause of death in white men over 65 years of age in industrial countries. Treatment of asymptomatic AAA is considered when the diameter of an AAA reaches 5.5 cm. There are two treatment options available: conventional open surgical repair or endovascular repair, which is a less invasive mode of treatment. After the operation heart and lung complications are significant in patients undergoing major abdominal surgery. The commonest causes of death are due to heart problems. There are various studies which have shown benefits of pre operative exercise training in patients undergoing orthopaedic, lung and heart bypass surgery. Currently, there is no data available with regards to the effect of pre-operative (before operation) supervised exercise in patients undergoing surgery for an AAA. The main aim of this study will be to determine whether a pre-operative supervised exercise programme improves post-operative (after operation) outcome, compared to standard treatment. Patients will be entered in the study once a decision to repair their AAA has been made by the consultant. They will undergo pre-operative assessment and will be divided randomly into two groups. One group will have exercise training for 4-6 weeks before surgery and the other will not. After the operation they will be followed during the post-operative period to determine the presence or absence of complications. It is anticipated that complications will be less in the group which has undertaken exercise training before operation.
Detailed Description
Study Phase N/A
Study Type † Interventional
Study Design † Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
Primary Outcome Measure † Composite outcome including cardiac, respiratory and renal complications
Secondary Outcome Measure † Length of ITU/ HDU stay, length of hospital stay (medical/ total), quality of life scores (SF-8 and EURQOL) & death within 30 days of surgery
Condition † Abdominal Aortic Aneurysm
Intervention † OtherSupervised exercise
Study Arms / Comparison Groups Supervised exercise group Control group - no exercise
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Other
Estimated Enrollment † 124
Start Date † December 2009
Completion Date July 2014
Primary Completion Date July 2014
Eligibility Criteria † Inclusion Criteria: - Patients undergoing open repair for an asymptomatic peri-renal and infra-renal abdominal aortic aneurysm. - Patients undergoing Endovascular aneurysm repair (EVAR). - Able to comply with study protocol. - Able to give informed consent. Exclusion Criteria: - Patients with severe disabling disorders limiting mobility for example severe osteoarthritis. - Patients undergoing emergency repair of Abdominal Aortic Aneurysm. - Patients with thoraco abdominal aneurysms. - Patients unable to communicate in English.
Gender Both
Ages 20 Years - N/A
Accepts Healthy Volunteers No
Contacts ††
Location Countries † United Kingdom
Administrative Information
NCT ID † NCT01062594
Organization ID R0858
Secondary IDs ††
Responsible Party Principal Investigator
Study Sponsor † University of Hull
Collaborators †† Hull and East Yorkshire Hospitals NHS Trust
Investigators † : ,
Information Provided By
Verification Date December 2014
First Received Date † February 3, 2010
Last Updated Date December 3, 2014
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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