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CompletedNCT01062594Updated Jul 15, 2019

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

An interventional study of Supervised exercise and Role of exercise in Abdominal Aortic Aneurysm, sponsored by Hull University Teaching Hospitals NHS Trust. Completed at 1 site in United Kingdom. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2019-07-15.

Sponsored by Hull University Teaching Hospitals NHS Trust · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
124
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Abdominal Aortic Aneurysm
03

In context

Aneurysm

960 studies on the registry are indexed under Aneurysm; 175 are open to participants now.

This study's enrollment of 124 is above the median of 72 across 462 interventional studies indexed under Aneurysm.

Browse Aneurysm studies →

Lead sponsor

Hull University Teaching Hospitals NHS Trust is the lead sponsor of 93 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
124 participants (actual)

Study arms

  • Active comparator
    Supervised exercise group

    Other: Supervised exercise · Other: Role of exercise · Other: Supervised exercise program

  • No intervention
    Control group - no exercise

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.

  • OtherSupervised exercise program

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

06

What researchers measure

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

07

Study locations

1 site
  • Hull & East Yorkshire Hospitals NHS Trust
    Hull, HU3 2JZ, United Kingdom
08

References and documents

Publications

  • 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. PubMed 26756766 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 15, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01062594
Lead sponsor
Hull University Teaching Hospitals NHS Trust
Responsible party
Sponsor
First posted
Feb 4, 2010
Start date
Dec 2009
Primary completion
Jul 2014
Completion
Jul 2014
Last update
Jul 15, 2019

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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