An interventional study of Community based exercise programme and Control in Aortic Aneurysm, Abdominal, sponsored by University of Manchester. Status unknown. Open to participants aged 60 Years to 85 Years. Per ClinicalTrials.gov, last updated 2018-10-17.
Sponsored by University of Manchester · Not applicable, Interventional, and Prevention
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.
960 studies on the registry are indexed under Aneurysm; 175 are open to participants now.
This study's planned enrollment of 58 is below the median of 72 across 462 interventional studies indexed under Aneurysm.
Browse Aneurysm studies →University of Manchester is the lead sponsor of 194 studies on the registry; 43 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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
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.
Behavioral: Community based exercise programme
20 week community (home or gym based) exercise programme
Usual care consisting of advice.
Peak VO2 as measured by CPET
Time frame: at 20 weeks
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
Weight, BMI, Waist Circumference and Blood Pressure
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
All outcome measures will also be measured at 10 weeks and compared with other time intervals.
Time frame: 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.
Time frame: at 30 weeks
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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University of Manchester