Sarcopenia in people on haemodialysis Musculoskeletal Diseases
Conditions
Interventions
Current interventions as of 31/03/2026:
Treatment method, duration and frequency:
Participants randomised to the intervention group will receive NMES at each dialysis session they attend for 3 months.
(2) Increasing stimulation intensity (current) which determines the strength of the muscle contraction that is induced and therefore how uncomfortable it can feel. Participants will be encouraged to i
Sponsors
University of Leicester
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 27/08/2025: 1. Undertaking HD for >3 months (home or unit-based) 2. Age >18 years 3. Has sarcopenia diagnosed by either: 3.1. Low handgrip strength 3.2. Prolonged Sit to Stand 5 score (>15 seconds for both men and women) if handgrip strength is above the sarcopenia threshold 4. Able to give written informed consent Previous inclusion criteria: 1. Undertaking HD for >3 months (home or unit-based) 2. Age >18 years 3. Has sarcopenia diagnosed by low muscle strength on patient screening (<27 kg for men and <16 kg for women for handgrip strength) 4. Able to give written informed consent
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 31/03/2026: 1. Contraindications to neuromuscular electrical stimulation therapy including: 1.1. Lower limb amputation 1.2. Active skin ulceration or infection 1.3. Critical lower limb ischaemia, including pain at rest or functional impairment that precludes completion of study assessments 1.4. Lower limb deep vein thrombosis <3 months 1.5. Cardiac pacemaker or implantable cardiac defibrillator 2. Conditions known to cause muscle wasting: 2.1. Known neuromuscular disease 2.2. Active malignancy 3. Scheduled for living donor kidney transplant or plan to change dialysis modality or centre in the next 6 months 4. Life expectancy of <6 months 5. Current participation in an interventional trial with conflicting therapies or outcomes 6. Unable to give written informed consent 7. Vascular access in the lower limbs that may interfere with intervention delivery Previous exclusion criteria as of 27/08/2025: 1. Contraindications to neuromuscular electrical stimulation therapy including: 1.1. Lower limb amputation 1.2. Active skin ulceration or infection 1.3. Critical lower limb ischaemia, including pain at rest or functional impairment that precludes completion of study assessments 1.4. Lower limb deep vein thrombosis <3 months 1.5. Cardiac pacemaker or implantable cardiac defibrillator 1.6. Metallic hip or knee joint 2. Conditions known to cause muscle wasting: 2.1. Known neuromuscular disease 2.2. Active malignancy 3. Scheduled for living donor kidney transplant or plan to change dialysis modality or centre in the next 6 months 4. Life expectancy of <6 months 5. Current participation in an interventional trial with conflicting therapies or outcomes 6. Unable to give written informed consent 7. Vascular access in the lower limbs that may interfere with intervention delivery Previous exclusion criteria: 1. Contraindications to neuromuscular electrical stimulation therapy including: 1.1. Lower limb amputation 1.2. Active skin ulceration or infection 1.3. Symptomatic lower limb claudication/ischaemia 1.4. Lower limb deep vein thrombosis <3 months 1.5. Cardiac pacemaker or implantable cardiac defibrillator 1.6. Metallic hip or knee joint 2. Conditions known to cause muscle wasting: 2.1. Known neuromuscular disease 2.2. Active malignancy 3. Scheduled for living donor kidney transplant or plan to change dialysis modality or centre in the next 6-months 4. Life expectancy of <6 months 5. Current participation in an interventional trial with conflicting therapies or outcomes 6. Unable to give written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Muscle strength measured using isometric strength at screening (as a familiarisation session) at baseline, 3, 6, and 9 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcomes as of 31/03/2026: 1. Quality of life measured using the Kidney Disease Quality of Life (KDQoL) tool at baseline, 3, 6, and 9 months 2. Cost-effectiveness, within an NHS costing perspective, measured using the EQ-5D-5L and a resource use questionnaire at baseline, 3, 6, and 9 months 3. Muscle size and physical function are measured using the following methods at baseline, 3, 6, and 9 months: 3.1. Muscle mass using ultrasound to assess thickness and cross-sectional area 3.2. Muscle quality and architecture using ultrasound e.g. echo intensity and angle of pennation 3.3. Handgrip strength using dynamometry 3.4. Lower-extremity strength, functional capacity, and balance using the Short Physical Performance Battery (SPPB) 3.5. Cardiovascular functional capacity and endurance using the 6-minute walk test or the Incremental Shuttle Walk Test (ISWT) (if space constraints) 3.6. Body composition using bioelectrical impedance 3.7. Isometric rate of force development measured using dynamometry at baseline, 3, 6 and 9 months 3.8. Physical activity levels using the GP Physical Activity questionnaire and accelerometry 3.9. Levels of fatigue using SONG-HD Fatigue score 3.10. Indices of sarcopenia using the SARC-F questionnaire 4. Neuromuscular adaptations and changes in muscle phenotype will be measured using the following methods at baseline and 3 months: 4.1. Motor unit recruitment, discharge rate, and conduction velocity using high-density electromyography 4.2. Motor unit potential jiggle and segment jitter using intramuscular electromyography 4.3. Evoked quadriceps contractile properties measured using electrical stimulation and force transducers at baseline and 3 months 4.4. Skeletal muscle fibre size, distribution, morphology, and mitochondrial function analysed from biopsy samples obtained using the needle biopsy technique at baseline and 3 months 5. The safety of the intervention measured using adverse events reporting relating to the intervention | — |
Countries
England, United Kingdom
Contacts
Public ContactNiamh Quann
Outcome results
None listed