Feasibility Study of Exercise Training for Abdominal Aortic Aneurysm Disease
Condition: Aortic Aneurysm, Abdominal; Aneurysm; Aortic Disease; Vascular Disease; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Aneurysm; Aortic Aneurysm; Vascular Diseases; Aortic Aneurysm, Abdominal; Aortic Diseases
Study type: Interventional

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.
    

Intervention name(s): Supervised exercise training
Intervention type(s): Behavioral
Intervention description(s): Patients will be asked to attend three exercise sessions per week for 12 weeks. They will exercise in groups of up to four per session and they will be supervised by an experienced exercise physiologist. Each session will comprise 5 to 10 min warm-up period (involving very light aerobic exercise and a range of gentle movements), 30 min of light-to-moderate intensity aerobic exercise (cycle-ergometry and or treadmill-walking), and a 5 to 10 min cool-down period involving low-intensity aerobic exercise and gentle stretching. The intensity of the aerobic exercise will be individualised and will be progressed gradually (if appropriate) during the course of the study.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Exercise; Aortic aneurysm; Feasibility; Vascular disease