Aortic Aneurysm, AbdominalNCT02997618
The AAA Get Fit Trial: A Pilot Randomised Controlled Trial of Community Based Exercise in Patients With Abdominal Aortic Aneurysms
A study testing Community based exercise programme in people with Aortic Aneurysm, Abdominal, run by University of Manchester.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Aortic Aneurysm, Abdominal
- What is being tested?
- Community based exercise programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- Nov 2018to Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 If any medical conditions are discovered during the study, these patients will be withdrawn from the study and referred to the necessary health professional.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
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- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
- Conditions
- Aortic Aneurysm, Abdominal
- Being tested
- Community based exercise programme, Control
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community based exercise programmeBehavioural
20 week community (home or gym based) exercise programme
ControlOther
Usual care consisting of advice.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | 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 Receives: Other: Control |
| Community Based Exercise Programme | Experimental | Community based-exercise (in addition to usual care) with the choice of either:
1. 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.
2. 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. Receives: Behavioral: Community based exercise programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak VO2 as measured by CPET
Measured: at 20 weeks
Secondary outcomes (8)
Anaerobic Threshold as measured by CPET
Measured: at 20 weeks
Biomarkers of Cardiovascular disease risk
Measured: at 20 weeks
Other risk factors of Cardiovascular disease risk
Weight, BMI, Waist Circumference and Blood Pressure
Measured: at 20 weeks
Subjective measure of habitual activity levels (PASE questionnaire)
Measured: at 20 weeks
Objective measure of habitual activity levels (via Accelerometry)
Measured: at 20 weeks
Health-related quality of life
Measured: at 20 weeks
Early changes in outcome measures
All outcome measures will also be measured at 10 weeks and compared with other time intervals.
Measured: 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.
Measured: at 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2016 (estimated)
- Study startNov 2018 (estimated)
- Primary completionJan 2019 (estimated)
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Aneurysm, AbdominalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Collaborators
- Manchester University NHS Foundation Trust
- Responsible party
- Principal investigator, Charles McCollum, University of Manchester
- Investigators
- Charles McCollum, MD, FRCS, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02997618
- Sponsor's protocol ID
- 162347
- Status last verified
- Oct 2018
- First submitted
- 15 Dec 2016
- Last updated
- 17 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02997618
- Acronym / sponsor ID
- 162347
- Conditions
- Aortic Aneurysm, Abdominal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Collaborators
- Manchester University NHS Foundation Trust
- Study start
- Nov 2018 (estimated)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 20 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Control1. 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 Programme | Experimental | Behavioral: Community based exercise programmeCommunity based-exercise (in addition to usual care) with the choice of either: 1. 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. 2. 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. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community based exercise programme20 week community (home or gym based) exercise programme | Behavioural | Community Based Exercise Programme |
| ControlUsual care consisting of advice. | Other | Control |
Primary outcome
Peak VO2 as measured by CPET
Time frame: at 20 weeks
8 secondary outcomes
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
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
Sustainability of changes in outcome measures
Time frame: at 30 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles McCollum, MD, FRCS principal investigator
University of Manchester
Questions about this trial
What is this clinical trial studying?
A study testing Community based exercise programme in people with Aortic Aneurysm, Abdominal, run by University of Manchester.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adam Haque, MBChB, MRCS (01612915848, adam.haque@manchester.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak VO2 as measured by CPET (time frame: at 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2018.