title: A non-randomised controlled trial of the clinical and cost effectiveness of a Supervised Exercise Programme for claudication.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  Non-randomised, controlled trial.
  
  
  METHODS
  University teaching hospital.
  
  
  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 pound1780 at 1 year.
  
  
  CONCLUSIONS
  Compared to CMT, SEP increases walking distances, improves QoL and is a highly cost-effective treatment for IC.
authors.affiliation: Academic Vascular Surgical Unit, Vascular Laboratory, Alderson House, Hull Royal Infirmary, Hull, UK.
authors.forename: H L D
authors.initials: HL
authors.lastname: Lee
authors.forename: T
authors.initials: T
authors.lastname: Mehta
authors.forename: B
authors.initials: B
authors.lastname: Ray
authors.forename: M S T
authors.initials: MS
authors.lastname: Heng
authors.forename: P T
authors.initials: PT
authors.lastname: McCollum
authors.forename: I C
authors.initials: IC
authors.lastname: Chetter
mesh_terms: D000368:Aged; D003362:Cost-Benefit Analysis; D005081:Exercise Therapy / Q000191:economics* / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007383:Intermittent Claudication / Q000191:economics / Q000503:physiopathology / Q000628:therapy; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D016896:Treatment Outcome; D016138:Walking / Q000502:physiology*