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

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 Aneurysms

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.

Study Overview

• Status: Unknown
• Conditions: Aortic Aneurysm, Abdominal
• Intervention / Treatment: Other: Control; Behavioral: Community based exercise programme

• Study Type: Interventional
• Enrollment (Anticipated): 58
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adam Haque, MBChB, MRCS; Phone Number: 01612915848; Email: adam.haque@manchester.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Men with an AAA ≥ 3.0 and < 5.0 cm and women with a AAA ≥ 3.0 and < 4.5 cm
2. Aged 60 - 85 years inclusive
3. Willing and able to engage in gym- and/or home-based exercise training and undertake CPET

Exclusion Criteria:

1. Unable or unwilling to undertake CPET or exercise training Patients unwilling will not be able to give informed consent and those who are unable would not be able to be randomised to the intervention study group nor undergo satisfactory testing to obtain our outcome measures.

2. High levels of habitual physical activity (those scoring "high" on the PASE questionnaire) These patients already have a high level of physical activity and therefore it may not be possible to improve their fitness any further which is the primary objective of the study.

   Exclusion criteria 3-10 are all based on medical conditions which would mean either exercise training may be unsafe, they would require further investigation and treatment of that medical condition or are likely to need upcoming intervention for their medical condition which would take priority over any participation in a research study. If any medical conditions are discovered during the study, these patients will be withdrawn from the study and referred to the necessary health professional.

3. Severe liver disease (INR > 2, serum albumin < 3.0g/dL, bilirubin > 50µmol/L)
4. Unstable angina, angina of < 2 month's duration, occurring more than twice daily, angina that is increasing in frequency or precipitated by less exertion, angina at rest
5. Uncontrolled atrial fibrillation (AF) or other arrhythmia: untreated paroxysmal AF
6. Moderate or severe aortic valve stenosis (peak systolic pressure gradient >40mmHg or with an aortic valve area < 1cm2)
7. Class II/III/IV heart failure and/or left ventricular ejection fraction < 25%
8. Pericarditis or myocarditis within last six months
9. Patients with > 2mm ST depression on exercise ECG will not be eligible to take part and will be referred to a cardiologist for further assessment.
10. Diagnosis or treatment for a malignancy over the previous 12 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Control; 1. Usual care (control) Usual care given to patients on AAA surveillance. This includes six-monthly or annual ultrasound measurements of AAA, attendance to surveillance clinic and written (APPENDIX A) and verbal advice on managing cardiovascular risk. This advice will be based on current widely available NHS patient information15 and consists of the following information with regard to: Smoking Exercise Weight Diet	Other: Control; Usual care consisting of advice.
EXPERIMENTAL: Community Based Exercise Programme; Community based-exercise (in addition to usual care) with the choice of either: Home-based exercise training Participants choosing to exercise at home will follow the programmes intended for this setting, with each exercise designed to be possible without the need for specialist equipment.; Gym-based exercise training Participants will exercise at their nearest Life Leisure LTD gym, following one of the instructor designed programmes , using a combination of aerobic and resistance equipment, as well as simple floor exercises. Duration and Frequency At least 50 minutes of exercise per day on three non-consecutive days of the week for 20 weeks.	Behavioral: Community based exercise programme; 20 week community (home or gym based) exercise programme

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Peak VO2 as measured by CPET	at 20 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Manchester
• Collaborators: Manchester University NHS Foundation Trust
• Investigators: Principal Investigator: Charles McCollum, MD, FRCS, University of Manchester

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 1, 2018
• Primary Completion (ANTICIPATED): January 1, 2019
• Study Completion (ANTICIPATED): April 1, 2019

Study Registration Dates

• First Submitted: December 15, 2016
• First Submitted That Met QC Criteria: December 19, 2016
• First Posted (ESTIMATE): December 20, 2016

Study Record Updates

• Last Update Posted (ACTUAL): October 17, 2018
• Last Update Submitted That Met QC Criteria: October 15, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: 162347

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No