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

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Abdominal aortic aneurysm
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Cook – Abdominal aortic aneurysm Cordis Corporation – Abdominal Aortic Aneurysm
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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.

Study Type

Interventional

Primary Outcome

Composite outcome including cardiac, respiratory and renal complications

Secondary Outcome

 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

Supervised exercise

Study Arms / Comparison Groups

 Supervised exercise group
Description:

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

All

Ages

20 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, ,

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations

NCT ID

NCT01062594

Organization ID

R0858

Responsible Party

Sponsor

Study Sponsor

Hull University Teaching Hospitals NHS Trust

Study Sponsor

, ,

Verification Date

July 2019