title: Patient recruitment and experiences in a randomised trial of supervised exercise training for individuals with abdominal aortic aneurysm.
abstract: We sought to describe patient recruitment and experiences in a randomised controlled trial of a 12-week (thrice weekly) supervised exercise program for patients with small abdominal aortic aneurysm (AAA). Potential patients were identified via AAA surveillance lists and vascular clinics and invited to participate in the study. Upon completion of baseline assessments, patients were randomly allocated 1:1 to exercise or usual care. Patients completing the exercise arm were invited to attend a focus group session to explore experiences of diagnosis, management of condition, trial recruitment, and expectations and experiences of the exercise program. Between January 2010 and September 2011, 545 patients were identified. The response rate to postal invitation was 81.7% (445/545), with 108 patients responding as "interested." Only 28 of these patients were eligible and recruited (46.7% of recruitment target), yielding an overall recruitment rate of 5.1%. However, the estimated recruitment rate among eligible patients was 23.7%. Twenty-five patients (89.3%) completed the study, and compliance to the exercise program was 94%. Participants attending the focus group session indicated that the exercise program was manageable, beneficial, and enjoyable. The feasibility of supervised exercise training in individuals with small AAA remains unclear. Our study revealed a poorer than expected recruitment rate, but good compliance to, and feedback for, the exercise intervention. We present potential explanations for these findings and suggestions for future trials involving similar populations.
authors.affiliation: Centre for Sport and Exercise Science, Sheffield Hallam University, Sheffield, United Kingdom.
authors.forename: Roshan C
authors.initials: RC
authors.lastname: Gunasekera
authors.affiliation: Centre for Sport and Exercise Science, Sheffield Hallam University, Sheffield, United Kingdom.
authors.forename: James
authors.initials: J
authors.lastname: Moss
authors.affiliation: Centre for Sport and Exercise Science, Sheffield Hallam University, Sheffield, United Kingdom.
authors.forename: Helen
authors.initials: H
authors.lastname: Crank
authors.affiliation: Faculty of Health and Wellbeing, Sheffield Hallam University, Sheffield, United Kingdom.
authors.forename: Pauline A
authors.initials: PA
authors.lastname: Mitchell
authors.affiliation: Sheffield Vascular Institute, Northern General Hospital, Sheffield, United Kingdom.
authors.forename: Shah
authors.initials: S
authors.lastname: Nawaz
authors.affiliation: Centre for Sport and Exercise Science, Sheffield Hallam University, Sheffield, United Kingdom. Electronic address: g.tew@shu.ac.uk.
authors.forename: Garry A
authors.initials: GA
authors.lastname: Tew
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000375:Aging; D017544:Aortic Aneurysm, Abdominal / Q000175:diagnosis / Q000628:therapy*; D005081:Exercise Therapy / Q000379:methods; D005260:Female; D017144:Focus Groups; D006801:Humans; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D018579:Patient Selection; D010865:Pilot Projects; D011788:Quality of Life; D018401:Sample Size; D013997:Time Factors; D016896:Treatment Outcome