Effect of Pre-operative Exercise in Abdominal Aortic Aneurysms (AAA) Patients.
Primary Purpose
Abdominal Aortic Aneurysm
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Supervised exercise
Role of exercise
Supervised exercise program
Sponsored by
About this trial
This is an interventional other trial for Abdominal Aortic Aneurysm
Eligibility 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.
Sites / Locations
- Hull & East Yorkshire Hospitals NHS Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Supervised exercise group
Control group - no exercise
Arm Description
Outcomes
Primary Outcome Measures
Composite outcome including cardiac, respiratory and renal complications
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
Full Information
NCT ID
NCT01062594
First Posted
February 3, 2010
Last Updated
July 11, 2019
Sponsor
Hull University Teaching Hospitals NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT01062594
Brief Title
Effect of Pre-operative Exercise in Abdominal Aortic Aneurysms (AAA) Patients.
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 Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hull University Teaching Hospitals NHS Trust
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Aortic Aneurysm
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
124 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Supervised exercise group
Arm Type
Active Comparator
Arm Title
Control group - no exercise
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Supervised exercise
Intervention Description
Exercise class, this will be performed three times a week with average duration of 40 minutes for 4-6 weeks.
Intervention Type
Other
Intervention Name(s)
Role of exercise
Intervention Description
Exercise class, this will be performed three times a week with average duration of 40 minutes for 4-6 weeks.
Intervention Type
Other
Intervention Name(s)
Supervised exercise program
Intervention Description
Exercise class, this will be performed three times a week with average duration of 40 minutes for 4-6 weeks.
Primary Outcome Measure Information:
Title
Composite outcome including cardiac, respiratory and renal complications
Time Frame
First three months after intervention
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Hull & East Yorkshire Hospitals NHS Trust
City
Hull
ZIP/Postal Code
HU3 2JZ
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
26756766
Citation
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.
Results Reference
result
Links:
URL
https://journals.lww.com/annalsofsurgery/fulltext/2016/07000/Preoperative_Supervised_Exercise_Improves_Outcomes.10.aspx
Description
Publication Link
Learn more about this trial
Effect of Pre-operative Exercise in Abdominal Aortic Aneurysms (AAA) Patients.
We'll reach out to this number within 24 hrs