Clinical Trial: The AAA Get Fit Trial: A Pilot Randomised Controlled Trial of Community Based Exercise in Patients With Abdominal Aortic Aneurysms

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: The AAA Get Fit Trial: A Pilot Randomised Controlled Trial of Community Based Exercise to Improve Fitness and Reduce Morbidity and Mortality of Patients With Abdominal Aortic Ane

Brief Summary:

Rupture of abdominal aortic aneurysms(AAA) causes 12,000 deaths/year in the UK.1 Elective repair to prevent this carries a perioperative mortality of 4.5% for open surgery and 1% for endovascular repair. This risk is associated with poor cardiorespiratory fitness which can be measured using Cardiopulmonary Exercise Testing(CPET) with the CPET variables, peak oxygen uptake(peakVO2)<15ml/kg/min and anaerobic threshold(AT)<10.2ml/kg/min identifying patients at increased risk of early death after AAA repair.3 These variables can therefore be used as surrogate markers for cardiovascular fitness and risk of mortality and morbidity in AAA surgery; optimising these markers should improve fitness and decrease this risk. The optimal duration and type of exercise training for improving peak VO2 and AT in AAA patients is not known. AAA patients are unique as they are motivated to reduce the risk of impending surgery but are afforded the time to improve their fitness as repair may not be needed for months or even years.

The investigators propose a pilot randomised controlled trial to explore the effectiveness of a 20-week community (either home or gym-based) exercise programme to achieve sustained improvements in peak VO2 and AT, as measured by CPET, in AAA patients. Changes in QoL, habitual activity levels and cardiovascular risk will also be assessed. The results will inform a definitive multicentre clinical trial on exercise to improve outcomes in elderly patients with cardiovascular disease and AAA.


Detailed Summary:
Sponsor: University of Manchester

Current Primary Outcome: Peak VO2 as measured by CPET [ Time Frame: at 20 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Anaerobic Threshold as measured by CPET [ Time Frame: at 20 weeks ]
  • Biomarkers of Cardiovascular disease risk [ Time Frame: at 20 weeks ]
  • Other risk factors of Cardiovascular disease risk [ Time Frame: at 20 weeks ]
    Weight, BMI, Waist Circumference and Blood Pressure
  • Subjective measure of habitual activity levels (PASE questionnaire) [ Time Frame: at 20 weeks ]
  • Objective measure of habitual activity levels (via Accelerometry) [ Time Frame: at 20 weeks ]
  • Health-related quality of life [ Time Frame: at 20 weeks ]
  • Early changes in outcome measures [ Time Frame: at 10 weeks ]
    All outcome measures will also be measured at 10 weeks and compared with other time intervals.
  • Sustainability of changes in outcome measures [ Time Frame: at 30 weeks ]
    All outcome measures recorded 10 weeks post cessation of exercise at 30 weeks and compared with the other time intervals.


Original Secondary Outcome:

Information By: University of Manchester

Dates:
Date Received: December 15, 2016
Date Started: April 2017
Date Completion: April 2019
Last Updated: December 21, 2016
Last Verified: December 2016