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

Primary Purpose

Aortic Aneurysm, Abdominal

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Community based exercise programme

Control

About this trial

This is an interventional prevention trial for Aortic Aneurysm, Abdominal

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.
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 If any medical conditions are discovered during the study, these patients will be withdrawn from the study and referred to the necessary health professional.
Severe liver disease (INR > 2, serum albumin < 3.0g/dL, bilirubin > 50µmol/L)
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
Uncontrolled atrial fibrillation (AF) or other arrhythmia: untreated paroxysmal AF
Moderate or severe aortic valve stenosis (peak systolic pressure gradient >40mmHg or with an aortic valve area < 1cm2)
Class II/III/IV heart failure and/or left ventricular ejection fraction < 25%
Pericarditis or myocarditis within last six months
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.
Diagnosis or treatment for a malignancy over the previous 12 months

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Community Based Exercise Programme

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Peak VO2 as measured by CPET

Secondary Outcome Measures

Anaerobic Threshold as measured by CPET

Biomarkers of Cardiovascular disease risk

Other risk factors of Cardiovascular disease risk

Weight, BMI, Waist Circumference and Blood Pressure

Subjective measure of habitual activity levels (PASE questionnaire)

Objective measure of habitual activity levels (via Accelerometry)

Health-related quality of life

Early changes in outcome measures

All outcome measures will also be measured at 10 weeks and compared with other time intervals.

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.

Full Information

NCT ID

NCT02997618

First Posted

December 15, 2016

Last Updated

October 15, 2018

Sponsor

University of Manchester

Collaborators

Manchester University NHS Foundation Trust

1. Study Identification

Unique Protocol Identification Number

NCT02997618

Brief Title

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

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 Aneurysms

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Unknown status

Study Start Date

November 2018 (Anticipated)

Primary Completion Date

January 2019 (Anticipated)

Study Completion Date

April 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Manchester

Collaborators

Manchester University NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Aortic Aneurysm, Abdominal

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

Active Comparator

Arm Description

Arm Title

Community Based Exercise Programme

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Community based exercise programme

Intervention Description

20 week community (home or gym based) exercise programme

Intervention Type

Other

Intervention Name(s)

Control

Intervention Description

Usual care consisting of advice.

Primary Outcome Measure Information:

Title

Peak VO2 as measured by CPET

Time Frame

at 20 weeks

Secondary Outcome Measure Information:

Title

Anaerobic Threshold as measured by CPET

Time Frame

at 20 weeks

Title

Biomarkers of Cardiovascular disease risk

Time Frame

at 20 weeks

Title

Other risk factors of Cardiovascular disease risk

Description

Weight, BMI, Waist Circumference and Blood Pressure

Time Frame

at 20 weeks

Title

Subjective measure of habitual activity levels (PASE questionnaire)

Time Frame

at 20 weeks

Title

Objective measure of habitual activity levels (via Accelerometry)

Time Frame

at 20 weeks

Title

Health-related quality of life

Time Frame

at 20 weeks

Title

Early changes in outcome measures

Description

All outcome measures will also be measured at 10 weeks and compared with other time intervals.

Time Frame

at 10 weeks

Title

Sustainability of changes in outcome measures

Description

All outcome measures recorded 10 weeks post cessation of exercise at 30 weeks and compared with the other time intervals.

Time Frame

at 30 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Men with an AAA ≥ 3.0 and < 5.0 cm and women with a AAA ≥ 3.0 and < 4.5 cm Aged 60 - 85 years inclusive Willing and able to engage in gym- and/or home-based exercise training and undertake CPET Exclusion Criteria: 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. 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. Severe liver disease (INR > 2, serum albumin < 3.0g/dL, bilirubin > 50µmol/L) 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 Uncontrolled atrial fibrillation (AF) or other arrhythmia: untreated paroxysmal AF Moderate or severe aortic valve stenosis (peak systolic pressure gradient >40mmHg or with an aortic valve area < 1cm2) Class II/III/IV heart failure and/or left ventricular ejection fraction < 25% Pericarditis or myocarditis within last six months 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. Diagnosis or treatment for a malignancy over the previous 12 months

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Adam Haque, MBChB, MRCS

Phone

01612915848

adam.haque@manchester.ac.uk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Charles McCollum, MD, FRCS

Organizational Affiliation

University of Manchester

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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