title: Supervised exercise training as an adjunctive therapy for venous leg ulcers: study protocol for a randomised controlled trial.
abstract: BACKGROUND
  Venous leg ulcers are common, chronic wounds that are painful and reduce quality of life. Compression therapy is known to assist in the healing of venous leg ulceration. Supervised exercise training that targets an improvement in calf muscle pump function might be a useful adjunctive therapy for enhancing ulcer healing and other aspects of physical and mental health. However, the evidence of exercise for individuals with venous ulcers is sparse. Here, we describe the protocol for a study that aims to assess the feasibility of undertaking a randomised controlled trial of a supervised exercise programme in people who are receiving compression for venous ulceration.
  
  
  METHODS
  This is a randomised, controlled, assessor-blinded, two-centre, feasibility trial with two parallel groups. Eighty adults who are receiving lower-limb compression for a venous leg ulcer will be randomly assigned to receive usual care (compression only) or usual care plus a 12-week supervised exercise programme. Participants in the exercise group will be invited to undertake three, 60-minute sessions of supervised exercise each week, and each session will involve a combination of treadmill walking, upright cycling and strength and flexibility exercises for the lower limbs. Participants will be assessed before randomisation and 3, 6 and 12 months after randomisation. Primary outcomes include rates of recruitment, retention and adherence. Secondary outcomes include time to ulcer healing, proportion of participants healed, percentage and absolute change in ulcer size, health-related quality of life (EQ-5D-5L and VEINES-QOL/Sym), lower-limb cutaneous microvascular function (laser Doppler flowmetry coupled with iontophoresis) and physical fitness (30-second sit-to-stand test, chair sit and reach test, 6-minute walk test and ankle range of motion). The costs associated with the exercise programme and health-care utilisation will be calculated. We will also complete interviews with a sub-sample of participants to explore their experiences of having a venous ulcer and the acceptability of the exercise intervention and study procedures.
  
  
  CONCLUSIONS
  Data from this study will be used to refine the supervised exercise programme, investigate the acceptability of the intervention and study design and determine the most appropriate outcome measures, thereby providing estimates of the factors needed to design an adequately powered trial across several centres.
  
  
  BACKGROUND
  Current Controlled Trials, ISRCTN10205425 (May 2014) - http://www.controlled-trials.com/ISRCTN10205425.
authors.affiliation: York Trials Unit, Department of Health Sciences, University of York, Heslington, York, YO10 5DD, UK. garry.tew@york.ac.uk.
authors.forename: Garry A
authors.initials: GA
authors.lastname: Tew
authors.affiliation: Health Economics and Decision Science, ScHARR, University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, UK. j.michaels@sheffield.ac.uk.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Michaels
authors.affiliation: Centre for Sport and Exercise Science, Collegiate Hall, Sheffield Hallam University, Collegiate Crescent, Sheffield, S10 2BP, UK. h.crank@shu.ac.uk.
authors.forename: Helen
authors.initials: H
authors.lastname: Crank
authors.affiliation: School of Sport and Exercise Science, College of Social Science, University of Lincoln, Brayford Campus, Lincoln, LN6 7TS, UK. gmiddleton@lincoln.ac.uk.
authors.forename: Geoff
authors.initials: G
authors.lastname: Middleton
authors.affiliation: Centre for Health and Social Care Research, Sheffield Hallam University, Montgomery House, Collegiate Crescent, Sheffield, S10 2BP, UK. a.gumber@shu.ac.uk.
authors.forename: Anil
authors.initials: A
authors.lastname: Gumber
authors.affiliation: Centre for Sport and Exercise Science, Collegiate Hall, Sheffield Hallam University, Collegiate Crescent, Sheffield, S10 2BP, UK. m.klonizakis@shu.ac.uk.
authors.forename: Markos
authors.initials: M
authors.lastname: Klonizakis
mesh_terms: D001642:Bicycling; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D004739:England; D005081:Exercise Therapy / Q000191:economics / Q000379:methods; D005240:Feasibility Studies; D005260:Female; D017048:Health Care Costs; D006801:Humans; D008297:Male; D008833:Microcirculation; D017060:Patient Satisfaction; D011788:Quality of Life; D012107:Research Design; D055070:Resistance Training; D013997:Time Factors; D016896:Treatment Outcome; D014647:Varicose Ulcer / Q000175:diagnosis / Q000191:economics / Q000503:physiopathology / Q000628:therapy*; D016138:Walking; D014945:Wound Healing