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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by University of Hull.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Hull and East Yorkshire Hospitals NHS Trust
Information provided by:
University of Hull
ClinicalTrials.gov Identifier:
NCT01062594
First received: February 3, 2010
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

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 Intervention
Abdominal Aortic Aneurysm
Other: Supervised exercise
Other: Role of exercise
Other: Supervised exercise program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
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.

Resource links provided by NLM:


Further study details as provided by University of Hull:

Primary Outcome Measures:
  • Composite outcome including cardiac, respiratory and renal complications [ Time Frame: First three months after intervention ] [ Designated as safety issue: No ]

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 [ Time Frame: First three months after intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 144
Study Start Date: December 2009
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: Non exercise group 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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01062594

Locations
United Kingdom
Hull & East Yorkshire Hospitals NHS Trust Recruiting
Hull, United Kingdom, HU3 2JZ
Contact: Junaid A Khan, MBBS, MRCS    0044-1482674643    junaid.khan@hey.nhs.uk   
Principal Investigator: Peter T McCollum, MB ChB, FRCSI, FRCSEd         
Sponsors and Collaborators
University of Hull
Hull and East Yorkshire Hospitals NHS Trust
  More Information

No publications provided

Responsible Party: Prof. Peter McCollum, Academic Vascular Surgery Unit, University of Hull.
ClinicalTrials.gov Identifier: NCT01062594     History of Changes
Other Study ID Numbers: R0858
Study First Received: February 3, 2010
Last Updated: February 3, 2010
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: National Health Service

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on October 19, 2014