Ignite Creation Date:
2024-05-06 @ 1:26 AM
Last Modification Date:
2024-10-26 @ 11:04 AM
Study NCT ID:
NCT01805973
Status:
TERMINATED
Last Update Posted:
2020-05-26
First Post:
2013-02-28
Brief Title:
Surviving Aneurysm Surgery A Pilot Study on Exercise Training in Abdominal Aortic Aneurysm Patients
Sponsor:
Manchester University NHS Foundation Trust
Organization:
Manchester University NHS Foundation Trust
Study Overview
Official Title:
Surviving Aneurysm Surgery A Pilot Randomised Controlled Trial on Exercise Training in Abdominal Aortic Aneurysm Patients
Status:
TERMINATED
Status Verified Date:
2020-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SAS
Brief 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 21 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
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 35 the AAA Quality Improvement Programmes AAAQIP target is to reduce this to under 35 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 55cm 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
1 Can a supervised exercise programme improve performance in CPET measures that predict outcome in AAA surgery
2 What is the optimal period of training needed to achieve a significant improvement in CPET scores
3 How long is any exercise-induced improvement in fitness sustained
4 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 x3week 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 eg 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 andor 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
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 55cm 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
1 Can a supervised exercise programme improve performance in CPET measures that predict outcome in AAA surgery
2 What is the optimal period of training needed to achieve a significant improvement in CPET scores
3 How long is any exercise-induced improvement in fitness sustained
4 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 x3week 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 eg 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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None