Feasibility Study of Exercise Training for Abdominal Aortic Aneurysm Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01234610
Recruitment Status : Completed
First Posted : November 4, 2010
Last Update Posted : December 20, 2017
Sheffield Hallam University
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Aortic Aneurysm, Abdominal Aneurysm Aortic Disease Vascular Disease Cardiovascular Disease Behavioral: Supervised exercise training Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exercise Therapy for Abdominal Aortic Aneurysm Disease: a Feasibility Study
Study Start Date : January 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Arm Intervention/treatment
Experimental: Exercise
Behavioral: Supervised exercise training
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.

No Intervention: Control
No exercise

Primary Outcome Measures :
  1. Feasibility [ Time Frame: 12 weeks ]
    We will monitor how feasible it is to recruit, test and train patients with small AAAs

Secondary Outcome Measures :
  1. Cardiopulmonary fitness [ Time Frame: 12 weeks ]
    Peak oxygen uptake and ventilatory threshold assessed during an incremental-load cycling test

  2. Quality of life [ Time Frame: 12 weeks ]
    Health-related quality of life assessed using the MOS SF-36 v2 questionaire

  3. Aneurysm size [ Time Frame: 12 weeks ]
    Aneurysm size as measured using B-mode ultrasound

  4. Blood biomarker of disease progression [ Time Frame: 12 weeks ]
    Fasting blood samples will be taken to assess changes in hs-CRP

  5. Blood biomarker of disease progression [ Time Frame: 12 weeks ]
    Fasting blood samples will be taken to assess changes in MMP-9

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01234610

United Kingdom
Sheffield Hallam University
Sheffield, South Yorkshire, United Kingdom, S102BP
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, South Yorkshire, United Kingdom, S57AU
Sponsors and Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield Hallam University
Principal Investigator: Shah Nawaz, MD Sheffield Teaching Hospitals NHS Foundation Trust
Principal Investigator: Garry A Tew, PhD Sheffield Hallam University

Responsible Party: Sheffield Teaching Hospitals NHS Foundation Trust Identifier: NCT01234610     History of Changes
Other Study ID Numbers: STH15455
First Posted: November 4, 2010    Key Record Dates
Last Update Posted: December 20, 2017
Last Verified: December 2017

Keywords provided by Sheffield Teaching Hospitals NHS Foundation Trust:
Aortic aneurysm
Vascular disease

Additional relevant MeSH terms:
Cardiovascular Diseases
Aortic Aneurysm
Vascular Diseases
Aortic Aneurysm, Abdominal
Aortic Diseases