Abstract

Abstract Background Physical inactivity among patients undergoing hemodialysis (HD) is a long-standing clinical problem. While exercise could be beneficial, post-dialysis fatigue, limited time availability, and severe frailty to travel often lead to poor adherence to conventional exercise programs. To address this gap, we proposed testing an alternative therapy using intradialytic plantar electrical nerve stimulation (IPENS) provided during the routine hemodialysis process. Methods Participants were randomized into either an intervention group (IG: n=16, age=57.6±3.6 years, BMI=29.7±1.5 kg/m2, female=31%) or a control group (CG: n=15, age=63.5±1.6 years, BMI=29.9±1.6 kg/m2, female=41%). The IG received 1-hour IPENS during routine hemodialysis process (3 sessions/week) for 12 weeks. The CG was provided with an identical but non-functional device for the same period. Participants and therapy-providers were blinded to the group allocation. Daily life physical activity (e.g., cumulative postures including sitting, standing, lying, and walking; walking characteristics including step count, number of unbroken walking bout, and postural transitions including sit to stand and stand to sit) was monitored remotely at baseline and 12-week for a period of 48h using a validated pendant sensor. To determine the effect of intervention, we estimated Cohen’s effect size d. In addition, time effect, group effect, and time×group effect were estimated using general linear model. Results All participants in the IG tolerated the IPENS and completed all therapy sessions, indicating the feasibility. In the IG, we observed significant increase in time spent in standing (Cohen's d=0.8, p=0.039) and walking (Cohen's d=0.82, p=0.034), number of walking episodes (d=0.88, p=0.024), and number of postural transitions (d=0.93, p=0.018) with a decrease in the average duration for sit to stand transition (d=0.87, p=0.032) compared to the CG. Conclusions This is an ongoing study and our target sample is 100 eligible participants. This study provides earlier results on IPENS therapy's feasibility and effectiveness as an alternative to exercise programs to improve daily life physical activity among people undergoing routine hemodialysis process. If the results were held at a larger sample, we could recommend routine

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