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

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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.

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Data availability

The data supporting this study's findings are available upon request. The authors understand the importance of data transparency and are committed to promoting scientific reproducibility. However, the data cannot be publicly available due to ethical and privacy considerations. Researchers interested in accessing the data may request the necessary information from the corresponding author.

Abbreviations

CKD:

Chronic kidney disease

DPN:

Diabetic peripheral neuropathy

HD:

Hemodialysis

iPENS:

Intradialytic plantar electrical stimulation

VEGF:

Vascular endothelial growth factor

VPT:

Vibration perception threshold

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Acknowledgements

We wish to thank Naima Rodriguez, Anmol Momin, and Maria Noun, who contributed in part in data management.

Funding

The project described was supported by a grant from the Qatar National Research Foundation, QNRF, (Award Numbers NPRP 10-0208-170400, http://www.qnrf.org/) and in-kind support from Hamad Medical Corporation, HMC (Doha, Qatar). The content is solely the responsibility of the authors and does not necessarily represent the official views of the QNRF or HMC.

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Authors and Affiliations

  1. Interdisciplinary Consortium on Advanced Motion Performance (iCAMP), Michael E. DeBakey Department of Surgery, Baylor College of Medicine, One Baylor Plaza, MS: BCM390, Houston, TX, 77030, USA

    Ram Kinker Mishra, Bijan Najafi, Rasha Bara & Myeounggon Lee

  2. Department of Nephrology, Hamad General Hospital, Doha, Qatar

    Abdullah Hamad, Rania Ibrahim, Mincy Mathew & Fadwa Al-Ali

  3. Diabetic Foot and Wound Clinic, Hamad Medical Co, Doha, Qatar

    Talal Talal

Authors
  1. Ram Kinker Mishra
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  2. Bijan Najafi
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  3. Abdullah Hamad
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  4. Rasha Bara
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  6. Rania Ibrahim
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  7. Mincy Mathew
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  8. Talal Talal
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  9. Fadwa Al-Ali
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Contributions

RM performed the statistical analysis, interpretation of data, drafting of the original manuscript, and critical revision of the manuscript for important intellectual content. RI and MM were involved in data collection and critical revision of the manuscript. RB, ML, FAA, AH, and TT contributed to the data interpretation and critical revision of the manuscript for important intellectual content. BN, FAA, AH, and TT contributed to the study concept and design, critical revision of the manuscript for important intellectual content, and securing funding.

Corresponding author

Correspondence to Bijan Najafi.

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Conflict of interest

None of the authors declared conflict of interest relevant to the scope of this study.

Ethical statement

This study received approval from the local Institutional Review Board (IRB) at Hamad Medical Corporation, under protocol number MRC 03-17-0010.

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Mishra, R.K., Najafi, B., Hamad, A. et al. Intradialytic plantar electrical nerve stimulation to improve mobility and plantar sensation among adults with diabetes undergoing hemodialysis: a randomized double-blind trial. J Nephrol 36, 1627–1637 (2023). https://doi.org/10.1007/s40620-023-01625-9

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