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Peer-reviewedCC BY 4.0Trials

Efficacy of neuromuscular electrical stimulation as a therapy for sarcopenia in people on haemodialysis: study protocol for the STIM-HD randomised controlled trial

1 more authors
16 affiliations
  1. 1Division of Cardiovascular Sciences, School of Medical Sciences, College of Life Sciences, University of Leicester, University Road, Leicester, LE1 7RH UK
  2. 2NIHR Biomedical Research Centre: Leicester, Leicester General Hospital, Gwendolen Road, Leicester, LE5 4PW UK
  3. 3School of Sport, Exercise and Health Sciences, National Centre for Sport and Exercise Medicine, Loughborough University, Towers Way, Loughborough, LE11 3TU UK
  4. 4Lived Experience Partner and STIM-HD Patient Co-Applicant, Blackburn, UK
  5. 5Leicester Clinical Trials Unit, College of Life Sciences, University of Leicester, University Road, Leicester, LE1 7RH UK
  6. 6Division of Public Health and Epidemiology, School of Medical Sciences, College of Life Sciences, University of Leicester, Leicester, UK
  7. 7University Hospitals Birmingham NHS Foundation Trust, Mindelsohn Way, Edgbaston, Birmingham, B15 2GW UK
  8. 8School of Health Sciences, University of Birmingham, Edgbaston, Birmingham, B15 2TT UK
  9. 9Warwick Medical School, University of Warwick, Coventry, CV4 7AL UK
  10. 10NIHR Applied Research Collaboration East Midlands, Leicester General Hospital, Gwendolen Road, Leicester, LE5 4PW UK
  11. 11Leicester British Heart Foundation Centre of Research Excellence, University of Leicester, University Road, Leicester, LE1 7RH UK
  12. 12University of Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, CV4 7AL UK
  13. 13Institute for Cardio-Metabolic Medicine, University Hospitals Coventry and Warwickshire NHS Trust, Clifford Bridge Road, Coventry, CV2 2DX UK
  14. 14University Hospitals Coventry and Warwickshire, Clifford Bridge Road, Binley, Coventry, CV2 2DX UK
  15. 15Research Governance Office, Research and Enterprise Division, University of Leicester, University Road, Leicester, LE1 7RH UK
  16. 16John Walls Renal Unit, University Hospitals of Leicester NHS Trust, Leicester General Hospital, Gwendolen Road, Leicester, LE5 4PW UK

Abstract

Background: Sarcopenia is highly prevalent among adults receiving haemodialysis and is associated with reduced physical function, impaired quality of life, and increased morbidity and mortality. Although structured exercise programmes can improve muscle health, most people receiving haemodialysis are unable or unwilling to participate, highlighting the need for accessible alternatives. Neuromuscular electrical stimulation (NMES) is a non-volitional method of muscle contraction that may act as an ‘exercise mimetic’. Early studies suggest benefits for muscle strength, mass, and function; however, robust evidence from adequately powered randomised trials is lacking. The STIM-HD study aims to evaluate the clinical efficacy, cost-effectiveness, and mechanistic effects of NMES in adults with sarcopenia receiving haemodialysis.

Methods: STIM-HD is a multi-centre, assessor-blind, randomised controlled trial that will recruit 228 adults receiving haemodialysis. Eligible participants must be receiving haemodialysis for at least 3 months, meet diagnostic criteria for handgrip strength, or prolonged sit to stand 5 performance. Participants will be randomised in a 1:1 manner to 12 weeks of NMES or 12 weeks of standard care. The intervention targets the quadriceps using a pre-defined protocol of high-frequency NMES, three times per week during routine dialysis. The primary outcome is the change in isometric muscle strength from baseline to 12 weeks. Secondary outcomes include muscle mass and architecture, physical function, body composition, physical activity, quality of life, safety, adherence, and healthcare resource use. Follow-up assessments will occur at 3, 6, and 9 months. A mechanistic outcomes sub-study will evaluate neuromuscular and molecular adaptations using electromyography, nerve stimulation, and analysis of skeletal muscle biopsies. Analyses will follow intention-to-treat principles and adjust for baseline values and minimisation factors.

Discussion: This study will provide a comprehensive evaluation of the efficacy of NMES to be used as a treatment for sarcopenia in patients receiving haemodialysis. By integrating functional, economic, and mechanistic outcomes, STIM-HD will generate evidence to inform whether this therapy should be adopted into routine clinical care, and offer essential insights into the biological processes underpinning molecular responses to this intervention.

Trial registration: ISRCTN43724916. Prospectively registered 29/11/2024.

Supplementary Information: The online version contains supplementary material available at https://doi.org/10.1186/s13063-026-09938-3.

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BibTeX
@article{watson2026efficacy,
  title = {{Efficacy of neuromuscular electrical stimulation as a therapy for sarcopenia in people on haemodialysis: study protocol for the STIM-HD randomised controlled trial}},
  author = {Emma L. Watson and Niamh Quann and Faizan Awan and Shaun R. Barber and Nicola Cooper and Indranil Dasgupta and Jonathan P. Folland and Laura J. Gray and Gordon McGregor and Jakob Škarabot and Meghan Tanel and Cat Taylor and James O. Burton},
  journal = {Trials},
  year = {2026},
  month = aug,
  doi = {10.1186/s13063-026-09938-3},
  url = {https://doi.org/10.1186/s13063-026-09938-3},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - Efficacy of neuromuscular electrical stimulation as a therapy for sarcopenia in people on haemodialysis: study protocol for the STIM-HD randomised controlled trial
AU  - Emma L. Watson
AU  - Niamh Quann
AU  - Faizan Awan
AU  - Shaun R. Barber
AU  - Nicola Cooper
AU  - Indranil Dasgupta
AU  - Jonathan P. Folland
AU  - Laura J. Gray
AU  - Gordon McGregor
AU  - Jakob Škarabot
AU  - Meghan Tanel
AU  - Cat Taylor
AU  - James O. Burton
PY  - 2026
DA  - 2026/08/11
JO  - Trials
DO  - 10.1186/s13063-026-09938-3
UR  - https://doi.org/10.1186/s13063-026-09938-3
AB  - Background: Sarcopenia is highly prevalent among adults receiving haemodialysis and is associated with reduced physical function, impaired quality of life, and increased morbidity and mortality. Although structured exercise programmes can improve muscle health, most people receiving haemodialysis are unable or unwilling to participate, highlighting the need for accessible alternatives. Neuromuscular electrical stimulation (NMES) is a non-volitional method of muscle contraction that may act as an ‘exercise mimetic’. Early studies suggest benefits for muscle strength, mass, and function; however, robust evidence from adequately powered randomised trials is lacking. The STIM-HD study aims to evaluate the clinical efficacy, cost-effectiveness, and mechanistic effects of NMES in adults with sarcopenia receiving haemodialysis.  Methods: STIM-HD is a multi-centre, assessor-blind, randomised controlled trial that will recruit 228 adults receiving haemodialysis. Eligible participants must be receiving haemodialysis for at least 3 months, meet diagnostic criteria for handgrip strength, or prolonged sit to stand 5 performance. Participants will be randomised in a 1:1 manner to 12 weeks of NMES or 12 weeks of standard care. The intervention targets the quadriceps using a pre-defined protocol of high-frequency NMES, three times per week during routine dialysis. The primary outcome is the change in isometric muscle strength from baseline to 12 weeks. Secondary outcomes include muscle mass and architecture, physical function, body composition, physical activity, quality of life, safety, adherence, and healthcare resource use. Follow-up assessments will occur at 3, 6, and 9 months. A mechanistic outcomes sub-study will evaluate neuromuscular and molecular adaptations using electromyography, nerve stimulation, and analysis of skeletal muscle biopsies. Analyses will follow intention-to-treat principles and adjust for baseline values and minimisation factors.  Discussion: This study will provide a comprehensive evaluation of the efficacy of NMES to be used as a treatment for sarcopenia in patients receiving haemodialysis. By integrating functional, economic, and mechanistic outcomes, STIM-HD will generate evidence to inform whether this therapy should be adopted into routine clinical care, and offer essential insights into the biological processes underpinning molecular responses to this intervention.  Trial registration: ISRCTN43724916. Prospectively registered 29/11/2024.  Supplementary Information: The online version contains supplementary material available at https://doi.org/10.1186/s13063-026-09938-3.
SN  - 1745-6215
ER  -