A Non-randomised Controlled Trial of the Clinical and Cost Effectiveness of a Supervised Exercise Programme for Claudication

• Published in: European journal of vascular and endovascular surgery 2007-02, Vol.33 (2), p.202-207
• Main Authors: Lee, H.L.D, Mehta, T, Ray, B, Heng, M.S.T, McCollum, P.T, Chetter, I.C
• Format: Article
• Language: English
• Subjects: Aged; Cost effectiveness; Cost-Benefit Analysis; Exercise Therapy - economics; Exercise Therapy - methods; Female; Follow-Up Studies; Humans; Intermittent claudication; Intermittent Claudication - economics; Intermittent Claudication - physiopathology; Intermittent Claudication - therapy; Male; Middle Aged; Quality of Life; Supervised exercise programme; Surgery; Treatment Outcome; Walking - physiology
• ISSN: 1078-5884; 1532-2165
• DOI: 10.1016/j.ejvs.2006.08.005

Objectives The main aims of treatment in patients with intermittent claudication (IC) are to improve the clinical indicators of lower limb ischaemia and patients' quality of life (QoL). The aims of this study were assess the clinical and cost effectiveness of a supervised exercise programme (SEP) in patients with IC. Design Non-randomised, controlled trial. Setting University teaching hospital. Patients and methods Two groups of patients with IC were studied. Seventy patients were sequentially recruited before and after the establishment of a Supervised Exercise Programme at our unit. Thirty-seven patients (median age 69 years, 26 men) received conservative medical therapy (CMT) and 33 patients (median age 67 years, 22 men) received CMT plus a 3 month SEP of graduated physical exercise for sixty minutes, three times each week. Patients were assessed prior to and at 6 months following treatment. At each assessment patient reported walking distances (PRWD), treadmill claudication and maximal distances (ICD and MWD), ankle brachial pressure indices (ABPI) pre & post exercise and patient reported QoL using the SF36 questionnaire were assessed. Results Prior to intervention the two groups were well matched. Following treatment, CMT patients demonstrated no significant change in PRWD or ICD but did record a small but significant improvement in MWD. CMT was also associated with a negative effect size in the SF36 index and in 7 of the 8 SF36 QoL domains, effect size >−0.5 for the domains of Physical Function and Emotional Role. SEP patients demonstrated significant improvement in PRWD, ICD and MWD. SEP was associated with a positive effect size in the SF36 index and in 2 SF36 QoL domains but a negative effect size in a further 2 domains. However, all QoL effect sizes following SEP were < ±0.5. Intergroup differences in effect sizes were >0.5 for the SF36 domains of Physical Function, Physical Role, Emotion Role and SF36 index. SEP resulted in a 0.027 quality adjusted life year (QALY) gain over CMT in the first year post-treatment thus the cost/QALY gained of SEP is £1780 at 1 year. Conclusions Compared to CMT, SEP increases walking distances, improves QoL and is a highly cost-effective treatment for IC.