Surviving Aneurysm Surgery: A Pilot Study on Exercise Training in Abdominal Aortic Aneurysm Patients

NCT01805973 | Terminated

• 1 other identifier: 2013VSAS001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Aortic Aneurysm; Aortic Disease; Vascular Disease; Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

• Cardiopulmonary Exercise Test Score

  The investigators will determine if supervised exercise training improves cardiopulmonary fitness. Peak oxygen uptake and ventilatory threshold will be assessed during an incremental-load cycling test.

  18 weeks

Secondary Outcomes (5)

• Cardiopulmonary Exercise Test Score

  12 weeks

• Cardiopulmonary Exercise Test Score

  36 weeks

• Health-related quality of life

  18 weeks

• Quality of Life

  18 weeks

• Cost

  18 weeks

Study Arms (2)

Control

NO INTERVENTION

Standard pre-operative care, no active intervention

Exercise Training

EXPERIMENTAL

Supervised Exercise Training Programme Patients will be required to attend three 50 minute exercise sessions per week for 18 weeks. They will exercise in groups of 8-12 and will be supervised by an experienced exercise physiologist. Each session will comprise a 15 minute warm up, 30 minutes of moderate intensity aerobic exercise followed by a 10 minute cool down period. The patients will have the option to choose from three different exercise programmes tailored to individuals of mixed abilities (and co-morbidities).

Behavioral: Exercise Training

Interventions

Exercise Training BEHAVIORAL

Patients will participate in a supervised exercise training programme for 18 weeks. Patients will participate in a 50 minute exercise regime three times a week.

Exercise Training

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead
• University of Manchester: collaborator

Study Sites (1)

University Hospital of South Manchester NHS Foundation Trust

Manchester, Lancashire, M23 9LT, United Kingdom

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; Aortic Diseases; Vascular Diseases; Cardiovascular Diseases

Interventions

Exercise

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Charles M McCollum, MD

  Manchester University NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2013
• First Posted: March 6, 2013
• Study Start: June 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: May 1, 2014
• Last Updated: May 26, 2020

Record last verified: 2020-05

Locations

GB (1)