Abdominal Aortic AneurysmSASNCT01805973
Surviving Aneurysm Surgery: A Pilot Study on Exercise Training in Abdominal Aortic Aneurysm Patients
A study testing Exercise Training in people with Abdominal Aortic Aneurysm and Aortic Disease, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Abdominal Aortic Aneurysm, Aortic Disease, Vascular Disease
- What is being tested?
- Exercise Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2013to May 2014
- 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 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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%
Show all 9Show fewer
- Active pericarditis or myocarditis
- CPET induced ischaemia
- Diagnosis or treatment for a malignancy (excluding skin) over the previous 12 months
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospital of South Manchester NHS Foundation Trust
Manchester, Lancashire, M23 9LT
About this study
Official title: Surviving Aneurysm Surgery: A Pilot Randomised Controlled Trial on Exercise Training in Abdominal Aortic Aneurysm Patients
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.
Read the detailed description
Abdominal aortic aneurysm (AAA) affects 4% of men aged 65-79, a prevalence rising as our population ages. As most patients suffering rupture die immediately, elective AAA repair is critical and the National AAA Screening Programme (NAAASP) is being implemented across the UK to identify AAAs for elective repair. Manchester is the first major urban population to be screened. The UK had the highest mortality rates following elective open AAA repair in Europe (7% v 3.5%); the AAA Quality Improvement Programme's (AAAQIP) target is to reduce this to under 3.5% by 2013.
The benefits of exercise across a broad spectrum of medical conditions are now increasingly recognised; especially in the elderly. Exercise training may reduce mortality and complications in major surgery. Cardiopulmonary exercise testing (CPET) measures cardiopulmonary reserve and predicts outcome in major surgery. The Manchester CPET study group demonstrated that anaerobic threshold (AT) and peak oxygen consumption (VO2 peak) predict 30 and 90-day mortality in elective AAA repair.
The investigators propose a pilot randomised controlled trial (RCT) to determine whether a structured exercise programme improves fitness measured by CPET, and the optimal duration of training for AAA surgery. As over 90% of AAAs detected by screening are < 5.5cm and enter surveillance, these patients offer a unique opportunity to explore the ideal duration of exercise training as surgery is not indicated for months or years.
100 participants on AAA surveillance will be recruited and randomised to either exercise training or standard preoperative care (50 in each arm) to answer the following research questions:
- Can a supervised exercise programme improve performance in CPET measures that predict outcome in AAA surgery?
- What is the optimal period of training needed to achieve a significant improvement in CPET scores?
- How long is any exercise-induced improvement in fitness sustained?
- The economic and health costs of a supervised exercise training programme
Exercise subjects will attend a 60 minute supervised exercise programme of moderate intensity (70% of heart rate reserve) x3/week at a local gym. All participants will undergo CPET assessment of cardiopulmonary fitness and complete a health-related quality of life (Medical Outcomes Study 36-Item Short-Form Health Survey) at baseline and 18 weeks. The exercise subjects will undergo further CPET studies at 6, 12 and 36 weeks to investigate the duration of training needed to optimise fitness and the length of time improvements in fitness persist. Other important health related outcomes include blood pressure and lipid profile and frequency of health service visits (e.g. General Practitioner appointments) will be recorded for all participants at baseline and 18 weeks to provide data on the effects of exercise on health care costs. Longitudinal regression models, with Normal and Poisson distributions as appropriate, will be used to assess differences between the groups with respect to CPET changes, other health-related outcomes and frequency of health service visits over the whole study period. This pilot study will also explore strategies to encourage participation and compliance with exercise which may also improve general health outcomes and save National Health Service (NHS) costs by reducing demand.
The overall aim is to collect the data needed to design a definitive multicentre trial on whether physical exercise reduces morbidity and/or mortality in AAA repair.
Those aged >65 are the fastest growing segment of our population. This pilot study will contribute to public health policy drive on the impact of physical activity on functional capacity, quality of life and independence.
- Being tested
- Exercise Training
- Medical subject headings
- Aortic Aneurysm, Abdominal, Aortic Diseases, Vascular Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Exercise Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 weeks
Secondary outcomes (5)
Cardiopulmonary Exercise Test Score
For the intervention (exercise) arm the investigators will assess the CPET score at 6 and 12 weeks to determine the optimal duration of exercise training.
Peak oxygen uptake and ventilatory threshold will be assessed during an incremental-load cycling test.
Measured: 12 weeks
Cardiopulmonary Exercise Test Score
The investigators will determine how long any improvements in fitness are sustained after exercise is stopped.
Peak oxygen uptake and ventilatory threshold will be assessed during an incremental-load cycling test.
Measured: 36 weeks
Health-related quality of life
Fasting blood samples will be taken to assess changes in lipid profile and other biomarkers of cardiovascular disease.
Blood pressure control will be monitored.
Measured: 18 weeks
Quality of Life
Health-related quality of life will be assessed using the Medical Outcomes Study Short Form-36 questionnaire.
Measured: 18 weeks
Cost
A preliminary economic analysis will be performed to determine the cost of prescribed exercise training before surgery.
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2013
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic AneurysmStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- University of Manchester
- Responsible party
- Sponsor
- Investigators
- Charles M McCollum, MD, Principal investigator, Manchester University NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01805973
- Sponsor's protocol ID
- 2013VSAS001
- Acronym
- SAS
- Status last verified
- May 2020
- First submitted
- 28 Feb 2013
- Last updated
- 26 May 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surviving Aneurysm Surgery: A Pilot Randomised Controlled Trial on Exercise Training in Abdominal Aortic Aneurysm Patients
- ClinicalTrials.gov ID
- NCT01805973
- Acronym / sponsor ID
- SAS / 2013VSAS001
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Collaborators
- University of Manchester
- Study start
- Jun 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 6 Mar 2013 (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.
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.
Detailed description
Abdominal aortic aneurysm (AAA) affects 4% of men aged 65-79, a prevalence rising as our population ages. As most patients suffering rupture die immediately, elective AAA repair is critical and the National AAA Screening Programme (NAAASP) is being implemented across the UK to identify AAAs for elective repair. Manchester is the first major urban population to be screened. The UK had the highest mortality rates following elective open AAA repair in Europe (7% v 3.5%); the AAA Quality Improvement Programme's (AAAQIP) target is to reduce this to under 3.5% by 2013.
The benefits of exercise across a broad spectrum of medical conditions are now increasingly recognised; especially in the elderly. Exercise training may reduce mortality and complications in major surgery. Cardiopulmonary exercise testing (CPET) measures cardiopulmonary reserve and predicts outcome in major surgery. The Manchester CPET study group demonstrated that anaerobic threshold (AT) and peak oxygen consumption (VO2 peak) predict 30 and 90-day mortality in elective AAA repair.
The investigators propose a pilot randomised controlled trial (RCT) to determine whether a structured exercise programme improves fitness measured by CPET, and the optimal duration of training for AAA surgery. As over 90% of AAAs detected by screening are < 5.5cm and enter surveillance, these patients offer a unique opportunity to explore the ideal duration of exercise training as surgery is not indicated for months or years.
100 participants on AAA surveillance will be recruited and randomised to either exercise training or standard preoperative care (50 in each arm) to answer the following research questions:
- Can a supervised exercise programme improve performance in CPET measures that predict outcome in AAA surgery?
- What is the optimal period of training needed to achieve a significant improvement in CPET scores?
- How long is any exercise-induced improvement in fitness sustained?
- The economic and health costs of a supervised exercise training programme
Exercise subjects will attend a 60 minute supervised exercise programme of moderate intensity (70% of heart rate reserve) x3/week at a local gym. All participants will undergo CPET assessment of cardiopulmonary fitness and complete a health-related quality of life (Medical Outcomes Study 36-Item Short-Form Health Survey) at baseline and 18 weeks. The exercise subjects will undergo further CPET studies at 6, 12 and 36 weeks to investigate the duration of training needed to optimise fitness and the length of time improvements in fitness persist. Other important health related outcomes include blood pressure and lipid profile and frequency of health service visits (e.g. General Practitioner appointments) will be recorded for all participants at baseline and 18 weeks to provide data on the effects of exercise on health care costs. Longitudinal regression models, with Normal and Poisson distributions as appropriate, will be used to assess differences between the groups with respect to CPET changes, other health-related outcomes and frequency of health service visits over the whole study period. This pilot study will also explore strategies to encourage participation and compliance with exercise which may also improve general health outcomes and save National Health Service (NHS) costs by reducing demand.
The overall aim is to collect the data needed to design a definitive multicentre trial on whether physical exercise reduces morbidity and/or mortality in AAA repair.
Those aged >65 are the fastest growing segment of our population. This pilot study will contribute to public health policy drive on the impact of physical activity on functional capacity, quality of life and independence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard pre-operative care, no active intervention |
| Exercise Training | Experimental | Behavioral: Exercise TrainingSupervised 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). |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
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 |
|---|---|---|
| Exercise TrainingPatients will participate in a supervised exercise training programme for 18 weeks. Patients will participate in a 50 minute exercise regime three times a week. | Behavioural | Exercise Training |
Primary outcome
Cardiopulmonary Exercise Test Score
Time frame: 18 weeks
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.
5 secondary outcomes
Cardiopulmonary Exercise Test Score
Time frame: 12 weeks
Cardiopulmonary Exercise Test Score
Time frame: 36 weeks
Health-related quality of life
Time frame: 18 weeks
Quality of Life
Time frame: 18 weeks
Cost
Time frame: 18 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2020.
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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 M McCollum, MD principal investigator
Manchester University NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Training in people with Abdominal Aortic Aneurysm and Aortic Disease, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
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 9 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: stopped early, as of the sponsor's last update on 26 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiopulmonary Exercise Test Score (time frame: 18 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 26 May 2020.