Feasibility Study of Exercise Training for Abdominal Aortic Aneurysm Disease

Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust (Other)

Overall Status

Completed

CT.gov ID

NCT01234610

Collaborator

Sheffield Hallam University (Other)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

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 :

Jan 1, 2010

Actual Primary Completion Date :

Dec 1, 2011

Actual Study Completion Date :

Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Exercise 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

Arm

Intervention/Treatment

Experimental: Exercise

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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 hs-CRP
Blood biomarker of disease progression [12 weeks]
Fasting blood samples will be taken to assess changes in MMP-9

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sheffield Hallam University	Sheffield	South Yorkshire	United Kingdom	S102BP
2	Sheffield Teaching Hospitals NHS Foundation Trust	Sheffield	South Yorkshire	United Kingdom	S57AU

Sponsors and Collaborators

Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield Hallam University

Investigators

Principal Investigator: Shah Nawaz, MD, Sheffield Teaching Hospitals NHS Foundation Trust
Principal Investigator: Garry A Tew, PhD, Sheffield Hallam University