An interventional study of Neuromuscular electrical stimulation and Sham Comparator in Acute Kidney Injury, Acute Kidney Injury KDIGO 2 and Acute Kidney Injury KDIGO 3, sponsored by University of Nottingham. Not yet recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by University of Nottingham · Not applicable, Interventional, and Treatment
Acute Kidney Injury is a serious, common illness that is associated with poor health outcomes. Prolonged hospitalisation is a common experience of patients admitted with this illness. The average hospital stay for patients with an acute kidney injury is approximately 12 days, which can have a significant impact on muscle mass, muscle strength and, as a result, physical function and quality of life after leaving hospital. These losses in muscle mass, strength and physical function are thought to be, at least in part, due to muscle disuse, which may be down to complex underlying mechanisms associated with the condition, but also due to the period of immobilisation and/or limited mobility during hospitalisation that most patients experience.
Neuromuscular Electrical Stimulation or NMES, is an alternative, passive form of exercise that this study will use to: 1) test whether this is a feasible treatment option for patients with acute kidney injury; 2) observe whether it can be used to maintain or improve muscle mass, strength, and physical function; and 3) test whether there is any impact on quality of life or the ability to engage with activities of daily living after being discharged from hospital.
NMES is done by attaching pads to the skin of the leg muscles which send electrical impulses to the nerves, which then causes muscles to contract involuntarily. NMES has been shown to improve strength in the leg muscles, as well as physical function and tolerance to exercise by mimicking voluntary muscle contractions in the muscle that is stimulated. This small study will help us to gain an understanding on how patients respond to NMES whilst in hospital and inform the design of future larger studies on the use of NMES in acute kidney injury patients.
Acute Kidney Injury (AKI) is a serious, common illness that is defined as a sudden loss in kidney function. AKI is associated with poor clinical outcomes such as increased morbidity, mortality and prolonged hospitalisation. Clinical research has tended to explore prevalence, risk of recurrence of AKI and prevention, leaving patient-focused outcomes such as physical function and quality of life understudied. AKI is also associated with increased muscle catabolism, and this is coupled with longer hospital stays that prolong immobilisation. As a result, many older patients experience a significant reduction in muscle mass, strength, and functional capacity, sometimes to the extent of a diagnosis of sarcopenia (age-associated loss of skeletal muscle mass, strength and function), which can extend far beyond the duration of their hospitalisation. Skeletal muscle disuse atrophy is known to occur within 4 days, and the average AKI patient's stay in hospital is approximately 12 days. These factors are therefore significant contributors to losses in skeletal muscle mass, strength and function in AKI.
Neuromuscular Electrical Stimulation (NMES) is an alternative, passive form of exercise that involves attaching electrodes to the belly of a specified anatomical site of skeletal muscle, through which a device transcutaneously applies intermittent electrical stimuli which then produces a strong, tetanic isometric muscle contraction, with the aim of retaining neuromuscular function. It has been used in studies investigating its use in geriatric patients who presented with sarcopenia and frailty, in which a significant improvement in knee extensor strength was identified. It has also been used for patients who were critically ill, with a previous study identifying that NMES at low and medium frequencies in combination with a standard physical therapy program was associated with a significant improvement in knee extensor strength and handgrip strength, functional capacity, and quality of life during hospitalisation. Another study found that NMES in addition to early mobilisation significantly improved isometric quadriceps strength as well as functional capacity and ability to engage in activities of daily living. A study that examined the use of bilateral NMES in patients with heart failure found that there was a significant improvement in functional capacity and exercise tolerance. Another study that examined the use of bilateral NMES in hospitalised patients with chronic obstructive pulmonary disorder found that there was a significant improvement in quadriceps force production and exercise tolerance. However, the feasibility of NMES intervention has not been tested within the context of AKI. The aims and objectives of this study are to investigate the feasibility of using bilateral quadriceps NMES in people who have AKI and to generate preliminary data on whether NMES can attenuate losses in muscle strength, mass, and function.
This is to be a single-centre, parallel-group, single-blind, randomised controlled trial. Participants will be randomised to either the intervention (max 10 days of NMES) or the control group (sham NMES) in a 1:1 approach, with a block size of 4. Participants will undergo randomisation for arm allocation by using sealed envelope (sealedenvelope.com). Minimisation factors of age (\< 60 years and ≥ 61 years) and Pre-existing Clinical Frailty Scale score (2 or ≥3) will be applied to ensure balanced groups.
Having been screened as potential participants meeting the inclusion/exclusion criteria, the patient will be approached to have the study explained, as well as have any questions answered. Patients will be provided with a participant information sheet and allowed time to make an informed decision. If screened patient does not decide to participate, this will be recorded for measurement of feasibility outcomes
Following the formalisation of consent, confirmation of eligibility, and randomisation, the baseline measurements will commence. We intend to record demographic and clinical information from the participant's electronic health records in the participant's case report form such as age, height, weight, sex, ethnicity, Charlson comorbidity score, AKI stage, Clinical Frailty Score, Length of Stay (days), laboratory data from routine clinical care (daily blood tests are performed in patients with severe AKI), and previous medical history. We also intend to use questionnaires and basic questioning to record information such as physical activity levels assessed by a retrospective, prior to hospitalisation International Physical Activity Questionnaire (IPAQ), and smoking status (never, former, current). These basic questions will be asked to the participant and recorded by the researcher. The participant will then have assessments of muscle strength, mass, and function.
On the morning of the intervention, participants will be visited by a member of the research team and have the NMES device electrodes fitted just above the proximal and distal heads of the vastus lateralis (VL) muscle, the proximal pad will be placed longitudinally across the upper outside area of the thigh just above the midzone of the VL and the distal pad will be placed longitudinally on the lower outside area of the thigh just below the midzone. Anatomical landmarks will be marked with a skinsafe marker pen. These will be identified by palpation of anatomical landmarks and marked with a skin-safe marker for the consistency of placement throughout the intervention. The device will be preset to the following specified settings: Electrical Muscle Stimulation (EMS); Synchronous; duration - 30 mins; Frequency - 30 hertz (Hz); Pulse Width - 300 microseconds (µs); Duty Cycle - 1:3 (2 seconds on, 6 seconds off); Intensity - Max tolerable - from 1 up to 99 milliamps (mA) (10 mA for CON/sham group); ramp time - 2 seconds. The first session will last 30 mins, during which a member of the research team will stay with the participant throughout. At the end of the first session, participants will be asked of their preferred time in the afternoon for their second session, it is recommended that at least 3 hours should elapse between each session. The second session will also last for 30 minutes.
Food/drink intake assessment will be conducted via 24-hour dietary recalls on days 1, 5 and 10 (or hospital discharge) in both the NMES and CON groups. The information collected will be used to assess energy and protein intake. On the final day, following the cessation of NMES either due to the participant staying the full 10 days or due to imminent discharge, measurements of muscle strength, mass, and function will be taken. Feasibility data on acceptability and tolerability would be collected via visual analogue scale (VAS) pain report and an average of scores will be calculated for all days they were able to report this.
Study procedures will be the same for 1-month and 3-month study visits. Participants will be asked to attend the Renal Department at Royal Derby Hospital (RDH) on a further two separate occasions. This will be at 1 month following the cessation of NMES/hospital discharge (whichever occurs first) and at 3-months following the cessation of NMES/hospital discharge (whichever occurs first). Both of these visits will coincide with routine clinic visits.
Participants will be contacted by a member of the research team to arrange the date and time of the first study visit within two weeks of hospital discharge. Once they have confirmed a date they will be reminded a week and 24h before their visit by email or phone call, whichever the participant prefers.
On the day of the visit, participants will have measurements of muscle strength knee extensor strength (KES) (5-10 mins), muscle function via the modified sit-to-stand 30 test (M-STS-30) (5-10 mins), vastus lateralis ultrasound (30 mins), appendicular skeletal muscle mass (ASM) via bioelectrical impedance analysis (BIA) (2mins), EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) (5-10 mins) and Barthel Index (5-10 mins) questionnaires by a trained member of the research team. Body composition will be assessed using the BIA device (2 mins).
As per routine clinical pathways, blood and urine tests will be requested by the clinical team and collected in advance of their clinic visit. This will include routine biochemistry and haematology tests and cystatin-C (which is used clinically to assess kidney function after AKI in patients in whom sarcopenia is suspected). All blood tests will be analysed in local NHS pathology laboratories. The creatinine muscle index (CMI) will be calculated from these results. The chief investigator will review all blood tests measured at 1-month and 3-month visits in parallel with their entry into the CRF. The blood samples will be collected as per routine clinical care (e.g. National Health Service [NHS] phlebotomy services, or by trained clinical staff in the renal department).
Following these measurements being taken, another follow-up will be scheduled 2 months after the 1-month follow-up visit, (i.e. 3 months following the cessation of NMES [+/- 10 days]).
The primary outcomes, being the feasibility findings will be used to inform the design of a potential larger study and the secondary outcomes to discover whether the study methods need refining.
1,691 studies on the registry are indexed under Acute Kidney Injury; 395 are open to participants now.
This study's planned enrollment of 30 is below the median of 100 across 817 interventional studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →University of Nottingham is the lead sponsor of 465 studies on the registry; 80 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Kidney Disease Improving Global Outcomes (KDIGO) definition of Acute Kidney Injury (AKI) stage 2 or 3
o (AKI stage 2: Serum Creatinine [SCr] ≥ 2.0 - 2.9 times baseline, urine output \< 0.5 mL/kg per hour for ≥ 12 hours; AKI stage 3: SCr increase ≥ 3.0 times baseline or increase in SCr to ≥ 4.0 mg/dL [≥ 353.6 µmol/L], urine output \< 0.3 mL/kg per hour for ≥ 24 hours, or anuria for ≥ 12 hours, or initiation of Kidney Replacement Therapy [KRT])
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This group will have NMES applied with the following preset settings: Electrical Muscle Stimulation (EMS); Synchronous; duration - 30 mins; Frequency - 30 hertz (Hz); Pulse Width - 300 microseconds (µs); Duty Cycle - 1:3 (2 seconds on, 6 seconds off); Intensity - Max tolerable - from 1 up to 99 milliamps (mA); ramp time - 2 seconds.
Device: Neuromuscular electrical stimulation
This group will have NMES applied with the following preset settings: Electrical Muscle Stimulation (EMS); Synchronous; duration - 30 mins; Frequency - 30 hertz (Hz); Pulse Width - 300 microseconds (µs); Duty Cycle - 1:3 (2 seconds on, 6 seconds off); Intensity - 10 milliamps (mA); ramp time - 2 seconds. Most notably, this group will receive NMES at lower intensity that is not substantial enough to elicit a muscle contraction but enough to cause a sensation.
Device: Sham Comparator
In the intervention group, we will set up the device with parameters that are informed by previous studies that have completed an NMES randomised controlled trial.
Also known as: NMES
For the sham group, all of the same stimulation parameters will be set to the same except for the intensity, which will be set to 10 mA. This will be enough to generate a sensation of the NMES happening, but it will not be enough to generate a tetanic muscle contraction.
Also known as: Sham NMES
Number of patients screened
Standard calculation of total number of patients screened.
Time frame: At screening.
What proportion of people screened were eligible to take part?
Standard calculation of the proportion of people screened were eligible to take part.
Time frame: At screening
What proportion of the eligible participants that were approached, were recruited?
Standard calculation of the proportion of the eligible participants that were approached and were recruited.
Time frame: At recruitment.
Change in muscle strength
Change in muscle strength defined by knee extensor strength and recorded in Newtons (N). Knee extensor strength will be measured by using a crane scale that will be modified to attach to the participant above the ankle joint. We will record 3 scores ideally within 5% of each other, of which we will take the highest recorded value as the final score. The crane scale will be attached to the lower leg using a padded ankle cuff that will be positioned two finger breadths above the lateral malleolus and secured to an immovable object posterior to the chair using an inelastic strap. The participant will then be asked to extend the leg against the resistance of the scale for 2-3 seconds before relaxing. The crane scale used will display values in Newtons (N).
Time frame: Change in muscle strength defined by knee extensor strength from baseline to end of intervention to 1 and 3-month follow-up visits. This would be a time frame of 3 months.
Change in muscle mass/architecture
Change in muscle mass/architecture as defined by ultrasound scans of the vastus lateralis muscle - cross-sectional area in square centimetres (cm2)
Time frame: From baseline to end of intervention and 1 and 3 month follow-up visits. The time frame of this will be 3 months.
Change in muscle mass/architecture
Change in muscle mass/architecture as defined by ultrasound scans of the vastus lateralis muscle - muscle thickness in centimetres (cm).
Time frame: Change in muscle mass/architecture from baseline to end of intervention and 1 and 3 month follow-up visits. The time frame of this will be 3 months.
Change in muscle mass/architecture
Change in muscle mass/architecture as defined by ultrasound scans of the vastus lateralis muscle - pennation angle in degrees (°)
Time frame: From baseline to end of intervention and 1 and 3 month follow-up visits. The time frame of this will be 3 months.
Change in muscle mass/architecture
Change in muscle mass/architecture as defined by ultrasound scans of the vastus lateralis muscle - fascicle length in millimetres (mm).
Time frame: From baseline to end of intervention and 1 and 3-month follow-up visits. The time frame of this will be 3 months.
Change in muscle function
Change in muscle function as defined by modified sit-to-stand 30 test score.
Time frame: Change in modified sit-to-stand 30 score from baseline to end of intervention (10 days or discharge), 1 and 3-month follow-up visits.
Change in EQ-5D-5L Index score
The EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) descriptive system assesses five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored across five levels of severity, from level 1 (no problems) to level 5 (extreme problems or unable to perform). Responses are converted into a single health utility index score using an appropriate country-specific value set. Higher scores indicate better health-related quality of life.
Time frame: Change from the 1-month follow-up visit to the 3-month follow-up visit (approximately 2 months).
Change in EQ Visual Analogue Scale (EQ VAS) Score
The EuroQol Visual Analogue Scale (EQ VAS) measures participants' self-rated overall health on a scale from 0 (the worst health you can imagine) to 100 (the best health you can imagine). Higher scores indicate better self-rated health.
Time frame: Change from the 1-month follow-up visit to the 3-month follow-up visit (approximately 2 months).
Change in ability to engage in activities of daily living
Change in ability to engage in activities of daily living as assessed by the Barthel Index questionnaire. The Barthel Index will be administered by a trained member of the research team to assess independence in activities of daily living. It consists of 10 items that assess feeding, bathing, grooming, dressing, bowel and bladder control, toilet use, transfers, mobility and stair use. Items are scored according to the level of assistance required, producing a total score from 0 to 20, with higher scores indicating greater independence.
Time frame: Change from 1 month follow-up to 3 month follow-up visit. This would leave a time frame of approximately 2 months.
Assessment of energy and protein intake
Assessment of energy and protein intake via 24h dietary recalls
Time frame: This will be conducted on days 1, 5, and 10/hospital discharge.
Creatinine muscle index (CMI)
Creatinine Muscle Index (CMI) will be assessed using routinely collected blood test results. CMI will be calculated using the method specified in the study protocol.
Time frame: At the 1-and 3-month follow up visits.
Appendicular Skeletal Muscle Mass (ASMM)
Appendicular Skeletal Muscle Mass (ASMM) will be measured using bioelectrical impedance analysis (BIA). ASMM represents the estimated skeletal muscle mass of the upper and lower limbs and will be expressed in kilograms (kg).
Time frame: At the 1-and 3-month follow up visits.
Plan to share: Yes — Individual participant data (IPD) will only be shared with local researchers overseeing aspects of this study and staff involved in the usual care of the patient. This may include demographic and clinical information such as age, height, weight and kidney function. This may also include and results of the assessments conducted as part of the study.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: IPD will be available from 19/10/2026 to 19/10/2028.
Access criteria: Research team members will only have access to a participant's personal data once the participant has consented to be part of the study. Usual care staff will have access to IPD throughout the duration of the participant's hospitalisation.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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