Feasibility Study of Exercise Training for Abdominal Aortic Aneurysm Disease

Exercise Therapy for Abdominal Aortic Aneurysm Disease: a Feasibility Study

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease; Aneurysm; Aortic Aneurysm, Abdominal; Vascular Disease; Aortic Disease
• Intervention / Treatment: Behavioral: Supervised exercise training

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
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • South Yorkshire
    • Sheffield, South Yorkshire, United Kingdom, S57AU
      • Sheffield Teaching Hospitals NHS Foundation Trust
    • Sheffield, South Yorkshire, United Kingdom, S102BP
      • Sheffield Hallam University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; No exercise
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility	We will monitor how feasible it is to recruit, test and train patients with small AAAs	12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
• Collaborators: Sheffield Hallam University
• Investigators: Principal Investigator: Garry A Tew, PhD, Sheffield Hallam University; Principal Investigator: Shah Nawaz, MD, Sheffield Teaching Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: November 3, 2010
• First Submitted That Met QC Criteria: November 3, 2010
• First Posted (Estimate): November 4, 2010

Study Record Updates

• Last Update Posted (Actual): December 20, 2017
• Last Update Submitted That Met QC Criteria: December 18, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Exercise; Feasibility; Aortic aneurysm; Vascular disease
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal; Aortic Diseases
• Other Study ID Numbers: STH15455