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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01062594
First Posted: February 4, 2010
Last Update Posted: December 4, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Hull and East Yorkshire Hospitals NHS Trust
Information provided by (Responsible Party):
Daniel Carradice, University of Hull
  Purpose

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.


Condition Intervention
Abdominal Aortic Aneurysm Other: Supervised exercise Other: Role of exercise Other: Supervised exercise program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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.

Resource links provided by NLM:


Further study details as provided by Daniel Carradice, University of Hull:

Primary Outcome Measures:
  • Composite outcome including cardiac, respiratory and renal complications [ Time Frame: First three months after intervention ]

Secondary Outcome Measures:
  • 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 [ Time Frame: First three months after intervention ]

Enrollment: 124
Study Start Date: December 2009
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Supervised exercise group Other: Supervised exercise
Exercise class, this will be performed three times a week with average duration of 40 minutes for 4-6 weeks.
Other: Role of exercise
Exercise class, this will be performed three times a week with average duration of 40 minutes for 4-6 weeks.
Other: Supervised exercise program
Exercise class, this will be performed three times a week with average duration of 40 minutes for 4-6 weeks.
No Intervention: Control group - no exercise

  Eligibility

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01062594


Locations
United Kingdom
Hull & East Yorkshire Hospitals NHS Trust
Hull, United Kingdom, HU3 2JZ
Sponsors and Collaborators
University of Hull
Hull and East Yorkshire Hospitals NHS Trust
  More Information

Responsible Party: Daniel Carradice, Hashem Barakat, University of Hull
ClinicalTrials.gov Identifier: NCT01062594     History of Changes
Other Study ID Numbers: R0858
First Submitted: February 3, 2010
First Posted: February 4, 2010
Last Update Posted: December 4, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases