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NCT Number: NCT01062594

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

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hull & East Yorkshire Hospitals NHS Trust

Hull, HU3 2JZ, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Supervised Exercise

Other

Exercise class, this will be performed three times a week with average duration of 40 minutes for 4-6 weeks.

Role of exercise

Other

Exercise class, this will be performed three times a week with average duration of 40 minutes for 4-6 weeks.

Supervised exercise program

Other

Exercise class, this will be performed three times a week with average duration of 40 minutes for 4-6 weeks.

Primary outcomes

  1. Composite outcome including cardiac, respiratory and renal complications

    Time frame: First three months after intervention

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Hull University Teaching Hospitals NHS Trust

Other Gov

Registry information

Official study title

A Randomised Controlled Trial to Assess the Effect of a Pre-operative Supervised Exercise Programme on Outcome Following Intervention for Abdominal Aortic Aneurysms.

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Feb 4, 2010
Registry last updated
Jul 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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