Brief Title
Surviving Aneurysm Surgery: A Pilot Study on Exercise Training in Abdominal Aortic Aneurysm Patients
Official Title
Surviving Aneurysm Surgery: A Pilot Randomised Controlled Trial on Exercise Training in Abdominal Aortic Aneurysm Patients
Brief Summary
An abdominal aortic aneurysm (AAA) is an enlargement or ballooning of the main artery
supplying high pressure blood from the heart to the body. AAAs may continue to stretch until
they burst (rupture) causing 7000 deaths per year in the United Kingdom (UK); 2.1% of all
deaths in men over 65. Planned repair before rupture is critical and the National AAA
Screening Programme (NAAASP) is being introduced to identify AAAs in men before rupture.
Screening will identify over 9000 men per year with a previously undiagnosed AAA. More than
90% of screen detected AAAs are small, do no require repair, enter ultrasound follow-up
(surveillance) and may benefit from exercise to improve fitness before repair.
Over 4000 elective AAA repairs per year are performed in the UK and it has been suggested
that exercise training and weight loss may reduce mortality and complications of AAA repair.
This pilot study will examine the feasibility of supervised exercise training for patients
with AAAs and determine the optimal duration of training to achieve worthwhile improvements
in fitness.
Detailed Description
Abdominal aortic aneurysm (AAA) affects 4% of men aged 65-79, a prevalence rising as our
population ages. As most patients suffering rupture die immediately, elective AAA repair is
critical and the National AAA Screening Programme (NAAASP) is being implemented across the UK
to identify AAAs for elective repair. Manchester is the first major urban population to be
screened. The UK had the highest mortality rates following elective open AAA repair in Europe
(7% v 3.5%); the AAA Quality Improvement Programme's (AAAQIP) target is to reduce this to
under 3.5% by 2013.
The benefits of exercise across a broad spectrum of medical conditions are now increasingly
recognised; especially in the elderly. Exercise training may reduce mortality and
complications in major surgery. Cardiopulmonary exercise testing (CPET) measures
cardiopulmonary reserve and predicts outcome in major surgery. The Manchester CPET study
group demonstrated that anaerobic threshold (AT) and peak oxygen consumption (VO2 peak)
predict 30 and 90-day mortality in elective AAA repair.
The investigators propose a pilot randomised controlled trial (RCT) to determine whether a
structured exercise programme improves fitness measured by CPET, and the optimal duration of
training for AAA surgery. As over 90% of AAAs detected by screening are < 5.5cm and enter
surveillance, these patients offer a unique opportunity to explore the ideal duration of
exercise training as surgery is not indicated for months or years.
100 participants on AAA surveillance will be recruited and randomised to either exercise
training or standard preoperative care (50 in each arm) to answer the following research
questions:
1. Can a supervised exercise programme improve performance in CPET measures that predict
outcome in AAA surgery?
2. What is the optimal period of training needed to achieve a significant improvement in
CPET scores?
3. How long is any exercise-induced improvement in fitness sustained?
4. The economic and health costs of a supervised exercise training programme
Exercise subjects will attend a 60 minute supervised exercise programme of moderate intensity
(70% of heart rate reserve) x3/week at a local gym. All participants will undergo CPET
assessment of cardiopulmonary fitness and complete a health-related quality of life (Medical
Outcomes Study 36-Item Short-Form Health Survey) at baseline and 18 weeks. The exercise
subjects will undergo further CPET studies at 6, 12 and 36 weeks to investigate the duration
of training needed to optimise fitness and the length of time improvements in fitness
persist. Other important health related outcomes include blood pressure and lipid profile and
frequency of health service visits (e.g. General Practitioner appointments) will be recorded
for all participants at baseline and 18 weeks to provide data on the effects of exercise on
health care costs. Longitudinal regression models, with Normal and Poisson distributions as
appropriate, will be used to assess differences between the groups with respect to CPET
changes, other health-related outcomes and frequency of health service visits over the whole
study period. This pilot study will also explore strategies to encourage participation and
compliance with exercise which may also improve general health outcomes and save National
Health Service (NHS) costs by reducing demand.
The overall aim is to collect the data needed to design a definitive multicentre trial on
whether physical exercise reduces morbidity and/or mortality in AAA repair.
Those aged >65 are the fastest growing segment of our population. This pilot study will
contribute to public health policy drive on the impact of physical activity on functional
capacity, quality of life and independence.
Study Type
Interventional
Primary Outcome
Cardiopulmonary Exercise Test Score
Secondary Outcome
Cardiopulmonary Exercise Test Score
Condition
Abdominal Aortic Aneurysm
Intervention
Exercise Training
Study Arms / Comparison Groups
Control
Description: Standard pre-operative care, no active intervention
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Behavioral
Estimated Enrollment
100
Start Date
June 2013
Completion Date
May 2014
Primary Completion Date
December 2013
Eligibility Criteria
Inclusion Criteria:
- Men or women with an AAA ≥3.5cm to <5.5cm in men and ≥3.5cm to <5.0cm in women
- Age 50-85 years and willing to consider exercise training
- Fit for either open or Endovascular Aneurysm Repair AAA repair
Exclusion Criteria:
- Unable to participate in an exercise test or inability to exercise consistently
because of musculoskeletal or other health problems
- History of severe liver disease (INR>2, serum albumin <3.0g/dL, jaundice)
- Unstable angina: Patients with angina of less than 2 months' duration, severe or
occurring three or more times per day, or angina that is becoming either more frequent
of precipitated by less exertion or angina at rest
- Uncontrolled atrial fibrillation (AF) or other arrhythmia: Untreated episodes of
paroxysmal AF in the last 3 months
- Moderate or severe aortic valve stenosis (peak systolic pressure gradient > 40mmHg and
with an aortic valve area of <1cm^2.
- Class III/IV heart failure and / or an ejection fraction <25%
- Active pericarditis or myocarditis
- CPET induced ischaemia
- Diagnosis or treatment for a malignancy (excluding skin) over the previous 12 months
Gender
All
Ages
50 Years - 85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Charles M McCollum, MD, ,
Location Countries
United Kingdom
Location Countries
United Kingdom
Administrative Informations
NCT ID
NCT01805973
Organization ID
2013VSAS001
Responsible Party
Sponsor
Study Sponsor
Manchester University NHS Foundation Trust
Collaborators
University of Manchester
Study Sponsor
Charles M McCollum, MD, Principal Investigator, Manchester University NHS Foundation Trust
Verification Date
May 2020