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

Abstract

IntroductionCardiovascular 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 analysisRenal 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 disseminationAll required ethical and regulatory approvals have been obtained. Findings will be disseminated through conference presentations, public platforms and academic publications.Trial registration numberProspectively registered; ISRCTN17122775.

Feasibility and acceptability of high-intensity interval training and moderate-intensity continuous training in kidney transplant recipients: the PACE-KD study

“…A full description of the trial protocol has been published [ 33 ]. This report adheres to the CONSORT guidelines for reporting pilot and feasibility trials.…”

“…The criterion for success of this feasibility study is based on recruitment, retention, and intervention adherence and acceptability. We revised our previously reported [ 33 ] progression criteria in favour of a more pragmatic approach. Specific criteria for progressing to a larger efficacy trial were co-produced between researchers, clinicians, and patients (Table 1 ) using a condensed version of a previously reported method prior to completion of the study [ 34 ].…”

“…Measures were also assessed at mid-training and 3 months post-training with the exception of cardiorespiratory fitness and habitual physical activity. A survey pack containing eight questionnaires was administered at each time point [ 33 ].…”