Effect of Pre-operative Exercise in Abdominal Aortic Aneurysms (AAA) Patients.
|ClinicalTrials.gov Identifier: NCT01062594|
Recruitment Status : Completed
First Posted : February 4, 2010
Last Update Posted : December 4, 2014
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 or disease||Intervention/treatment||Phase|
|Abdominal Aortic Aneurysm||Other: Supervised exercise Other: Role of exercise Other: Supervised exercise program||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||124 participants|
|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.|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||July 2014|
|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|
- Composite outcome including cardiac, respiratory and renal complications [ Time Frame: First three months after intervention ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01062594
|Hull & East Yorkshire Hospitals NHS Trust|
|Hull, United Kingdom, HU3 2JZ|