Physical activity promotion for patients transitioning to dialysis using the “Exercise is Medicine” framework: a multi-center randomized pragmatic trial (EIM-CKD trial) protocol

BACKGROUND: Patients on dialysis are physically inactive, with most reporting activity levels below the fifth percentile of healthy age-matched groups. Several small studies have reported efficacy of diverse exercise interventions among persons with CKD and those on dialysis. However, no single intervention has been widely adopted in real-world practice, despite a clear need in this vulnerable population with high rates of mortality, frailty, and skilled nursing hospitalizations. METHODS/DESIGN: We describe a pragmatic clinical trial for an exercise intervention among patients transitioning to dialysis. We will use an existing framework – Exercise is Medicine (EIM) – developed by the American College of Sports Medicine. After undertaking formative qualitative research to tailor the EIM framework to the advanced CKD population (eGFR < 30 ml/min/1.73m(2)), we will randomize 96 patients from two regions—Atlanta and Bay Area—in two intervention arms with incremental levels of clinical-community integration: physical activity assessment during Nephrology clinical visit, brief counseling at pre-dialysis education, and physical activity wearable (group 1) versus group 1 intervention components plus a referral to a free, EIM practitioner-led group exercise program over 16 weeks (group 2; 8 week core intervention; 8-week follow up). We will assess efficacy by comparing between group differences in minutes/week of objectively measured moderate intensity physical activity. To evaluate implementation, we will use questionnaires for assessing barriers to referral, participation and retention along the path of the intervention. Further we will have a plan for dissemination of the intervention by partnering with relevant stakeholders. DISCUSSION: The overall goal is to inform the development of a practical, cost-conscious intervention “package” that addresses barriers and challenges to physical activity commonly faced by patients with advanced CKD and can be disseminated amongst interested practices. TRIAL REGISTRATION: ClinicalTrials.gov identifier (Dated:10/17/2017): NCT03311763.