title: Design and methods of CYCLE-HD: improving cardiovascular health in patients with end stage renal disease using a structured programme of exercise: a randomised control trial.
abstract: There is emerging evidence that exercise training could positively impact several of the cardiovascular risk factors associated with sudden cardiac death amongst patients on haemodialysis. The primary aim of this study is to evaluate the effect of an intradialytic exercise programme on left ventricular mass.
  
  
  
  Prospective, randomised cluster open-label blinded endpoint clinical trial in 130 patients with end stage renal disease on haemodialysis. Patients will be randomised 1:1 to either 1) minimum of 30 min continuous cycling thrice weekly during dialysis or 2) standard care. The primary outcome is change in left ventricular mass at 6 months, assessed by cardiac MRI (CMR). In order to detect a difference in LV mass of 15 g between groups at 80 % power, a sample size of 65 patients per group is required. Secondary outcome measures include abnormalities of cardiac rhythm, left ventricular volumes and ejection fraction, physical function measures, anthropometric measures, quality of life and markers of inflammation, with interim assessment for some measures at 3 months.
  
  
  
  This study will test the hypothesis that an intradialytic programme of exercise leads to a regression in left ventricular mass, an important non-traditional cardiovascular risk factor in end stage renal disease. For the first time this will be assessed using CMR. We will also evaluate the efficacy, feasibility and safety of an intradialytic exercise programme using a number of secondary end-points. We anticipate that a positive outcome will lead to both an increased patient uptake into established intradialytic programmes and the development of new programmes nationally and internationally.
  
  
  
  ISRCTN11299707 (registration date 5(th) March 2015).
authors.affiliation: John Walls Renal Unit, University Hospitals Leicester NHS Trust, Leicester, UK. mpmgb1@le.ac.uk.|Department of Infection Immunity and Inflammation, School of Medicine and Biological Sciences, University of Leicester, Leicester, LE1 9HN, UK. mpmgb1@le.ac.uk.|National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK. mpmgb1@le.ac.uk.
authors.forename: M P M
authors.initials: MP
authors.lastname: Graham-Brown
authors.affiliation: John Walls Renal Unit, University Hospitals Leicester NHS Trust, Leicester, UK.|Department of Infection Immunity and Inflammation, School of Medicine and Biological Sciences, University of Leicester, Leicester, LE1 9HN, UK.
authors.forename: D S
authors.initials: DS
authors.lastname: March
authors.affiliation: John Walls Renal Unit, University Hospitals Leicester NHS Trust, Leicester, UK.|Department of Infection Immunity and Inflammation, School of Medicine and Biological Sciences, University of Leicester, Leicester, LE1 9HN, UK.
authors.forename: D R
authors.initials: DR
authors.lastname: Churchward
authors.affiliation: John Walls Renal Unit, University Hospitals Leicester NHS Trust, Leicester, UK.|Department of Infection Immunity and Inflammation, School of Medicine and Biological Sciences, University of Leicester, Leicester, LE1 9HN, UK.
authors.forename: H M L
authors.initials: HM
authors.lastname: Young
authors.affiliation: John Walls Renal Unit, University Hospitals Leicester NHS Trust, Leicester, UK.|Department of Infection Immunity and Inflammation, School of Medicine and Biological Sciences, University of Leicester, Leicester, LE1 9HN, UK.
authors.forename: M
authors.initials: M
authors.lastname: Dungey
authors.affiliation: Robertson Centre for Biostatistics University of Glasgow, Glasgow, UK.
authors.forename: S
authors.initials: S
authors.lastname: Lloyd
authors.affiliation: John Walls Renal Unit, University Hospitals Leicester NHS Trust, Leicester, UK.|Department of Infection Immunity and Inflammation, School of Medicine and Biological Sciences, University of Leicester, Leicester, LE1 9HN, UK.
authors.forename: N J
authors.initials: NJ
authors.lastname: Brunskill
authors.affiliation: John Walls Renal Unit, University Hospitals Leicester NHS Trust, Leicester, UK.|Department of Infection Immunity and Inflammation, School of Medicine and Biological Sciences, University of Leicester, Leicester, LE1 9HN, UK.
authors.forename: A C
authors.initials: AC
authors.lastname: Smith
authors.affiliation: John Walls Renal Unit, University Hospitals Leicester NHS Trust, Leicester, UK.|Department of Cardiovascular Sciences, University of Leicester and NIHR Leicester Cardiovascular Biomedical Research Unit, Glenfield Hospital Leicester, Leicester, UK.
authors.forename: G P
authors.initials: GP
authors.lastname: McCann
authors.affiliation: John Walls Renal Unit, University Hospitals Leicester NHS Trust, Leicester, UK.|Department of Infection Immunity and Inflammation, School of Medicine and Biological Sciences, University of Leicester, Leicester, LE1 9HN, UK.|Department of Cardiovascular Sciences, University of Leicester and NIHR Leicester Cardiovascular Biomedical Research Unit, Glenfield Hospital Leicester, Leicester, UK.
authors.forename: J O
authors.initials: JO
authors.lastname: Burton
mesh_terms: D049628:Body Size; D002306:Cardiac Volume; D002320:Cardiovascular Physiological Phenomena; D016757:Death, Sudden, Cardiac / Q000517:prevention & control; D015444:Exercise / Q000502:physiology*; D005081:Exercise Therapy / Q000009:adverse effects; D006801:Humans; D017379:Hypertrophy, Left Ventricular / Q000000981:diagnostic imaging* / Q000503:physiopathology / Q000628:therapy*; D007249:Inflammation / Q000097:blood; D007676:Kidney Failure, Chronic / Q000150:complications / Q000503:physiopathology / Q000628:therapy*; D008279:Magnetic Resonance Imaging; D011788:Quality of Life; D006435:Renal Dialysis; D012107:Research Design; D013318:Stroke Volume
keywords: Cardiovascular disease; Haemodialysis; Intra-dialytic cycling; Intra-dialytic exercise; Sudden cardiac death