Randomized Controlled Trial of Intradialytic Cycling as Kidney Exercise Rehabilitation for Cardiac Stunning in Hemodialysis (TICKERS_HD): A Clinical Research Protocol

Abstract

Introduction: People with hemodialysis-dependent kidney failure experience significantly higher cardiovascular (CV) morbidity, mortality, symptom burden, and cognitive impairment compared to the general population. Hemodialysis-induced ischemia contributes to myocardial stunning, which worsens CV outcomes. Intradialytic cycling has the potential to mitigate cardiac stunning, but its effects have not been assessed in randomized controlled trials (RCTs). Methods: This multicenter RCT evaluates the impact of 12 weeks of intradialytic cycling on hemodialysis-induced myocardial stunning. The study will recruit 160 adults (80 intervention and 80 control) receiving maintenance hemodialysis at five Canadian centers and one Australian center. Outcome assessments are conducted at baseline, 12 weeks, and 16 weeks. An intervention implementation process evaluation is part of this study. Outcomes: The primary outcome is change in number of regional wall motion abnormalities (RWMAs) at peak hemodialysis stress from baseline to 12 weeks. Secondary outcomes include changes in cognitive function, hemodialysis recovery time, and symptom burden. Statistical Analysis: Change in number of RWMAs at peak hemodialysis stress from baseline to 12 weeks are compared between study groups using an independent 2-tailed t test and using a Poisson generalized linear mixed model with study group as a fixed effect, and time and mean ultrafiltration rate as random effects. Conclusion: Compared with standard care, we anticipate that intradialytic cycling will decrease myocardial stunning, resulting in improved symptom burden, and functional and cognitive status. This trial provides critical evidence regarding the benefits and feasibility of exercise during hemodialysis, potentially informing clinical practice, and guidelines for hemodialysis care. Trial registration number: NCT04877041.