Objectively measured daily steps as an outcome in a clinical trial of chronic kidney disease: a systematic review

Background: Physical inactivity is prevalent among individuals with chronic kidney disease (CKD) and is linked to unfavorable outcomes. In recent years, daily steps have emerged as a prominent target for interventions in clinical trials. The present study endeavors to scrutinize the effectiveness and/or efficacy of various interventions on daily steps in patients with full-spectrum CKD.

Methods: In December 2022, a systematic search was conducted across three databases, namely PubMed, Embase, and Web of Science, and subsequently updated in June 2023. The inclusion criteria included randomized controlled studies, quasi-experimental studies, and single-arm trials that assessed an intervention's impact on objectively measured daily steps in patients with chronic kidney disease. The Risk Of Bias In Non-randomized Studies-of Interventions (ROBINS-I) tool was used to assess the risk of bias in non-randomized controlled trials (RCT), while the Cochrane revised tool (ROB-2) was utilized for RCTs.

Results: Seventeen studies were deemed eligible for inclusion in this review, with a focus on examining the efficacy and/or effectiveness of exercise training-based interventions (n = 10), daily step goal-oriented interventions (n = 4), mobile health (mHealth) interventions (n = 1), different dialysis modalities (n = 1), and a "Sit Less, Interact, Move More" intervention (n = 1). The studies exhibit variability in their characteristics and assessment tools, reflecting the findings' heterogeneity. The results indicate that increasing physical activity levels remain challenging, as only a limited number of studies demonstrated significant improvements in participants' daily step counts from baseline to endpoint.

Conclusion: Clinical trials with daily steps as an outcome are still lacking in the CKD population. Well-designed clinical trials that objectively assess the physical activity of CKD patients are needed.