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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01062594
Enrollment
124
Registered
2010-02-04
Start date
2009-12-31
Completion date
2014-07-31
Last updated
2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Aortic Aneurysm

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.

Interventions

OTHERSupervised exercise

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

OTHERRole of exercise

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

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

Sponsors

Hull University Teaching Hospitals NHS Trust
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Composite outcome including cardiac, respiratory and renal complicationsFirst three months after intervention

Secondary

MeasureTime frame
Length of ITU/ HDU stay, length of hospital stay (medical/ total), quality of life scores (SF-8 and EURQOL) & death within 30 days of surgeryFirst three months after intervention

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026