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Physical activity, immune function and inflammation in kidney patients (the PINK study): a feasibility trial protocol
  1. Patrick James Highton1,2,
  2. Jill Neale2,
  3. Thomas J Wilkinson2,
  4. Nicolette C Bishop1,2,
  5. Alice C Smith1,2
  1. 1School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK
  2. 2Department of Infection, Immunity and Inflammation, University of Leicester, Leicester, UK
  1. Correspondence to Patrick James Highton; p.highton{at}lboro.ac.uk

Abstract

Introduction Patients with chronic kidney disease (CKD) display increased infection-related mortality and elevated cardiovascular risk only partly attributed to traditional risk factors. Patients with CKD also exhibit a pro-inflammatory environment and impaired immune function. Aerobic exercise has the potential to positively impact these detriments, but is under-researched in this patient population. This feasibility study will investigate the effects of acute aerobic exercise on inflammation and immune function in patients with CKD to inform the design of larger studies intended to ultimately influence current exercise recommendations.

Methods and analysis Patients with CKD, including renal transplant recipients, will visit the laboratory on two occasions, both preceded by appropriate exercise, alcohol and caffeine restrictions. On visit 1, baseline assessments will be completed, comprising anthropometrics, body composition, cardiovascular function and fatigue and leisure time exercise questionnaires. Participants will then undertake an incremental shuttle walk test to estimate predicted peak O2 consumption (VO2peak). On visit 2, participants will complete a 20 min shuttle walk at a constant speed to achieve 85% estimated VO2peak. Blood and saliva samples will be taken before, immediately after and 1 hour after this exercise bout. Muscle O2 saturation will be monitored throughout exercise and recovery. Age and sex-matched non-CKD ‘healthy control’ participants will complete an identical protocol. Blood and saliva samples will be analysed for markers of inflammation and immune function, using cytometric bead array and flow cytometry techniques. Appropriate statistical tests will be used to analyse the data.

Ethics and dissemination A favourable opinion was granted by the East Midlands-Derby Research Ethics Committee on 18 September 2015 (ref 15/EM/0391), and the study was approved and sponsored by University Hospitals of Leicester Research and Innovation (ref 11444). The study was registered with ISRCTN (ref 38935454). The results will be presented at relevant conferences, and it is anticipated that the reports will be published in appropriate journals in 2018.

  • renal transplantation
  • nephrology
  • immunology
  • inflammation
  • exercise

This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

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Footnotes

  • Contributors PJH wrote this manuscript; JN was involved in study design and protocol preparation; TJW was involved in study design and preparation of protocol amendments; NCB was involved in study design; ACS lead study design and protocol preparation. All authors reviewed this manuscript.

  • Funding We are grateful to the Stoneygate Trust for partially funding this study. This work is supported by the National Institute for Health Research (NIHR) Diet, Lifestyle & Physical Activity Biomedical Research Unit based at University Hospitals of Leicester and Loughborough University. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health.

  • Competing interests None declared.

  • Patient consent Obtained from patients.

  • Ethics approval REC East Midlands-Derby (ref 15/EM/0391).

  • Provenance and peer review Not commissioned; externally peer reviewed.