Participant acceptability of exercise in kidney disease (PACE-KD): a feasibility study protocol in renal transplant recipients

BMJ Open. 2017 Sep 24;7(9):e017494. doi: 10.1136/bmjopen-2017-017494.

Abstract

Introduction: Cardiovascular disease (CVD) is a major cause of mortality in renal transplant recipients (RTRs). General population risk scores for CVD underestimate the risk in patients with chronic kidney disease (CKD) suggesting additional non-traditional factors. Renal transplant recipients also exhibit elevated inflammation and impaired immune function. Exercise has a positive impact on these factors in patients with CKD but there is a lack of rigorous research in RTRs, particularly surrounding the feasibility and acceptability of high-intensity interval training (HIIT) versus moderate-intensity continuous training (MICT) in this population. This study aims to explore the feasibility of three different supervised aerobic exercise programmes in RTRs to guide the design of future large-scale efficacy studies.

Methods and analysis: Renal transplant recipients will be randomised to HIIT A (16 min interval training with 4, 2 and 1 min intervals at 80%-90% of peak oxygen uptake (VO2 peak)), HIIT B (4×4 min interval training at 80%-90% VO2peak) or MICT (~40 min cycling at 50%-60% VO2peak) where they will undertake 24 supervised sessions (approximately thrice weekly over 8 weeks). Assessment visits will be at baseline, midtraining, immediate post-training and 3 months post-training. The study will evaluate the feasibility of recruitment, randomisation, retention, assessment procedures and the implementation of the interventions. A further qualitative sub-study QPACE-KD (Qualitative Participant Acceptability of Exercise in Kidney Disease) will explore patient experiences and perspectives through semistructured interviews and focus groups.

Ethics and dissemination: All required ethical and regulatory approvals have been obtained. Findings will be disseminated through conference presentations, public platforms and academic publications.

Trial registration number: Prospectively registered; ISRCTN17122775.

Keywords: cardiovascular disease; exercise; feasibility; high intensity interval training; immunology; inflammation; renal transplantation.

MeSH terms

  • Cardiovascular Diseases / complications
  • Cardiovascular Diseases / prevention & control*
  • Clinical Protocols
  • Exercise / psychology*
  • Feasibility Studies
  • Female
  • High-Intensity Interval Training / methods*
  • Humans
  • Kidney Transplantation / adverse effects*
  • Male
  • Patient Acceptance of Health Care
  • Patient Reported Outcome Measures
  • Qualitative Research
  • Renal Insufficiency, Chronic / complications
  • Transplant Recipients*