Feasibility Study of Exercise Training for Abdominal Aortic Aneurysm Disease

Not Applicable

Completed

• Conditions: Aneurysm; Aortic Aneurysm, Abdominal; Aortic Disease; Vascular Disease; Cardiovascular Disease
• Interventions: Behavioral: Supervised exercise training

• Registration Number: NCT01234610
• Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

Brief Summary

An abdominal aortic aneurysm (AAA) is a weakened and enlarged area in the abdominal aorta, which is a large blood vessel in the abdomen. Large AAAs (\>55 mm diameter) carry a high risk of rupture, a surgical emergency that often leads to death due to severe internal bleeding. It has been suggested that regular exercise training might limit the rate at which AAAs develop. However, little is known about the safety and effectiveness of exercise training in these patients. This pilot study will examine the feasibility of supervised aerobic exercise training for patients with small AAAs (30 to 49 mm diameter). The investigators hypothesize that exercise training will be safe and useful for patients with small AAAs.

Detailed Description

Abdominal aortic aneurysm (AAA) disease is a potentially lethal health problem of older adults. New screening initiatives will identify many individuals with small (30 to 49 mm) AAAs for which there are currently no treatment options. Regular aerobic exercise might retard AAA disease progression, but the feasibility and acceptability of aerobic exercise in patients with AAA disease has yet to be established. This pilot study will examine the feasibility of supervised aerobic exercise and exercise advice-only in patients with small AAAs. A total of 60 volunteers will be recruited and randomly allocated to one of the two groups. Patients in the supervised exercise programme will be offered three supervised cycle ergometry/treadmill-walking sessions for a period of 12 weeks. The feasibility of each intervention will be assessed in terms of recruitment and compliance, attrition, changes in cardiopulmonary fitness and objective measures of free-living physical activity. Changes in aneurysm size and blood markers associated with disease progression will also be monitored and the impact of the interventions on health-related quality of life assessed using a questionnaire. Outcomes will be assessed at baseline and 12 weeks. We will also conduct focus groups at the end of the trial to obtain qualitative feedback from patients. The results of this study will inform the design of a multi-centre randomised controlled trial with longer-term follow-up of clinical end-points.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-11-03
• Study First Submitted QC: 2010-11-03
• Study First Posted: 2010-11-04
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-18
• Last Update Posted: 2017-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Men or women identified as having a stable 30 to 49 mm asymptomatic, infra-renal AAA, measured using high-resolution B-mode ultrasonography
• Ability to undertake exercise testing and training

Exclusion Criteria

• Patients with large (>50 mm)/symptomatic AAAs
• Patients with contraindications to exercise testing/training (e.g. severe hypertension, unstable metabolic/cardiopulmonary conditions, musculoskeletal injuries etc...)
• Patients who are unable to travel to the testing and training facility at Sheffield Hallam University
• Patients who are already participating in regular exercise
• Patients with a mental impairment that would render consent unethical or would make compliance difficult (e.g. dementia or Alzheimer's)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise	Supervised exercise training	Exercise

Primary Outcome Measures

Name	Time	Method
Feasibility	12 weeks	We will monitor how feasible it is to recruit, test and train patients with small AAAs

Secondary Outcome Measures

Name	Time	Method
Cardiopulmonary fitness	12 weeks	Peak oxygen uptake and ventilatory threshold assessed during an incremental-load cycling test
Quality of life	12 weeks	Health-related quality of life assessed using the MOS SF-36 v2 questionaire
Aneurysm size	12 weeks	Aneurysm size as measured using B-mode ultrasound
Blood biomarker of disease progression	12 weeks	Fasting blood samples will be taken to assess changes in MMP-9

Trial Locations

Locations (2)

Sheffield Hallam University; 🇬🇧 Sheffield, South Yorkshire, United Kingdom

Sheffield Teaching Hospitals NHS Foundation Trust; 🇬🇧 Sheffield, South Yorkshire, United Kingdom