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

NCT01062594 | Completed DMC

• 1 other identifier: R0858
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Aortic Aneurysm

Outcome Measures

Primary Outcomes (1)

• Composite outcome including cardiac, respiratory and renal complications

  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

  First three months after intervention

Study Arms (2)

Supervised exercise group

ACTIVE COMPARATOR

Other: Supervised exercise; Other: Role of exercise; Other: Supervised exercise program

Control group - no exercise

NO INTERVENTION

Interventions

Supervised exercise OTHER

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

Supervised exercise group

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 group

Supervised exercise program OTHER

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

Supervised exercise group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hull University Teaching Hospitals NHS Trust: lead

Study Sites (1)

Hull & East Yorkshire Hospitals NHS Trust

Hull, HU3 2JZ, United Kingdom

Location

Related Publications (1)

• Barakat HM, Shahin Y, Khan JA, McCollum PT, Chetter IC. Preoperative Supervised Exercise Improves Outcomes After Elective Abdominal Aortic Aneurysm Repair: A Randomized Controlled Trial. Ann Surg. 2016 Jul;264(1):47-53. doi: 10.1097/SLA.0000000000001609.

  PMID: 26756766 RESULT

Related Links

• Publication Link

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2010
• First Posted: February 4, 2010
• Study Start: December 1, 2009
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: July 15, 2019

Record last verified: 2019-07

Locations

GB (1)