A Remote Home-Based Rehabilitation Intervention for Kidney Transplant Candidates

(PLEASE KEEP IN WORD, DO NOT PDF) Kidney failure is the 8th leading cause of death in the United States. Kidney transplantation (KT) is the preferred and optimal form of kidney replacement therapy because it improves survival and quality of life and is less costly than dialysis. Nearly 100,000 individuals in the U.S. are currently awaiting KT, but due to a severe undersupply of available organs, waiting time for KT often exceeds five years, and 12 individuals die each day waiting for a KT. Prolonged waiting times leave most KT candidates at high risk for physical function impairment and frailty, as kidney failure accelerates declines in muscle mass, strength, and performance that are compounded by high rates of physical inactivity. Nearly one in five KT candidates is frail, and an even greater number have physical impairments, increasing their risk of poor pre- and post-KT outcomes. Given the prognostic relationship between pre-KT physical function and adverse outcomes, the American Society of Transplantation and Kidney Disease International Group Outcomes developed recommendations to increase KT candidates’ functional capacities prior to transplant surgery to mitigate complications and maximize patient and graft survival. Growing evidence from major abdominal surgery literature demonstrates prehabilitation (i.e. interventions to increase fitness, wellbeing, and physiological reserve capacity prior to surgery) is feasible, and can improve functional capacity, as well as improve pre- and post-operative outcomes. Prehabilitation represents an exciting intervention for KT candidates, but evidence of such interventions in this population is lacking. A home-based prehabilitation intervention guided by behavior change theory that leverages technology represents an acceptable and feasible option to improve physical activity and function and reduce frailty in KT candidates. We will test such an intervention among a high-risk KT candidate population in a randomized trial to determine its feasibility and acceptability (Aim 1), effects on physical activity and function and frailty (Aim 2), and explore for its early efficacy on pre- and post-KT outcomes. To address the study aims, we will include a community advisory board to refine the study protocol and trial processes and conduct a two-arm randomized controlled trial comparing an online prehabilitation program with physical activity monitored by a Fitbit vs. an attention control at 12 weeks and a 12-week post-intervention follow up period to explore for durability. The central hypothesis is that a home-based prehabilitation intervention will be feasible, increase physical activity and function, reduce frailty, and have beneficial effects on pre- and post-KT outcomes relative to control. Ultimately, this study will determine the feasibility and early effects of a theory-informed prehabilitation program which could translate into health improvements and cost savings among the high-risk population on the KT waitlist. The methodically robust intervention has the ambition to serve as an accessible, scalable, and sustainable program that will be recommended by clinicians and used by KT candidates as an element of their ongoing management to improve their health and optimize pre- and post-KT outcomes.