Intradialytic plantar electrical nerve stimulation to improve mobility and plantar sensation among adults with diabetes undergoing hemodialysis: a randomized double-blind trial

Abstract

Background: Impaired mobility is a debilitating consequence of hemodialysis. We examined the efficacy of intradialytic-plantar-electrical-nerve-stimulation (iPENS) to promote mobility among diabetes patients undergoing hemodialysis..

Methods: Adults with diabetes undergoing hemodialysis received either 1-h active iPENS, (Intervention-Group) or non-functional iPENS (Control-Group) during routine hemodialysis for 12 weeks (3 sessions/week). Participants and care-providers were blinded. Mobility (assessed using a validated pendant-sensor) and neuropathy (quantified by vibration-perception-threshold test) outcomes were assessed at baseline and 12 weeks.

Results: Among 77 enrolled subjects (56.2 ± 2.6 years old), 39 were randomly assigned to the intervention group, while 38 were assigned to the control group. No study-related adverse events and dropouts were reported in the intervention group. Compared to the control group, significant improvements with medium to large effect sizes were observed in the intervention group at 12 weeks for mobility-performance metrics, including active-behavior, sedentary-behavior, daily step counts, and sit-to-stand duration variability (p < 0.05), Cohen's d effect size (d = 0.63-0.84). The magnitude of improvement in active-behavior was correlated with improvement in the vibration-perception-threshold test in the intervention group (r = - 0.33, p = 0.048). A subgroup with severe-neuropathy (vibration-perception-threshold > 25 V) showed a significant reduction in plantar numbness at 12 weeks compared to baseline (p = 0.03, d = 1.1).

Conclusions: This study supports feasibility, acceptability, and effectiveness of iPENS to improve mobility and potentially reduce plantar numbness in people with diabetes undergoing hemodialysis. Considering that exercise programs are not widely used in hemodialysis clinical practice, iPENS may serve as a practical, alternative solution to reduce hemodialysis-acquired weakness and promote mobility.

Keywords: Acquired weakness; Diabetes; Digital biomarkers; Digital outcomes; Electrical stimulation; Hemodialysis; Intradialytic intervention; Mobility; Wearables.