Neuromuscular Electrical Stimulation to Improve the Muscle Health of Individuals With Acute Kidney Injury
NCT07915713, Not applicable, Not yet recruiting, University of Nottingham
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Neuromuscular Electrical Stimulation to Improve the Muscle Health of Individuals With Acute Kidney Injury | ClinicalTrials.gov |
| NCT number | NCT07915713 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 30 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | University of Nottingham | ClinicalTrials.gov |
| Conditions | Acute Kidney Injury, Acute Kidney Injury KDIGO 2, Acute Kidney Injury KDIGO 3, Muscle Wasting, Neuromuscular Electrical Stimulation (NMES) | ClinicalTrials.gov |
| Interventions | Neuromuscular electrical stimulation, Sham Comparator | ClinicalTrials.gov |
| First posted | 2026-11-04 | ClinicalTrials.gov |
| Last updated | 2026-11-04 | ClinicalTrials.gov |
Registered outcomes 15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Number of patients screened | At screening. | Standard calculation of total number of patients screened. | ClinicalTrials.gov |
| Primary | What proportion of people screened were eligible to take part? | At screening | Standard calculation of the proportion of people screened were eligible to take part. | ClinicalTrials.gov |
| Primary | What proportion of the eligible participants that were approached, were recruited? | At recruitment. | Standard calculation of the proportion of the eligible participants that were approached and were recruited. | ClinicalTrials.gov |
| Secondary | Change in muscle strength | 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 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). | ClinicalTrials.gov |
| Secondary | 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 as defined by ultrasound scans of the vastus lateralis muscle - cross-sectional area in square centimetres (cm2) | ClinicalTrials.gov |
| Secondary | Change in muscle mass/architecture | 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 as defined by ultrasound scans of the vastus lateralis muscle - muscle thickness in centimetres (cm). | ClinicalTrials.gov |
| Secondary | 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 as defined by ultrasound scans of the vastus lateralis muscle - pennation angle in degrees (°) | ClinicalTrials.gov |
| Secondary | 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 as defined by ultrasound scans of the vastus lateralis muscle - fascicle length in millimetres (mm). | ClinicalTrials.gov |
| Secondary | Change in muscle function | 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 muscle function as defined by modified sit-to-stand 30 test score. | ClinicalTrials.gov |
| Secondary | Change in EQ-5D-5L Index score | Change from the 1-month follow-up visit to the 3-month follow-up visit (approximately 2 months). | 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. | ClinicalTrials.gov |
| Secondary | Change in EQ Visual Analogue Scale (EQ VAS) Score | Change from the 1-month follow-up visit to the 3-month follow-up visit (approximately 2 months). | 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. | ClinicalTrials.gov |
| Secondary | Change in ability to engage in activities of daily living | Change from 1 month follow-up to 3 month follow-up visit. This would leave a time frame of approximately 2 months. | 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. | ClinicalTrials.gov |
| Secondary | Assessment of energy and protein intake | This will be conducted on days 1, 5, and 10/hospital discharge. | Assessment of energy and protein intake via 24h dietary recalls | ClinicalTrials.gov |
| Secondary | Creatinine muscle index (CMI) | At the 1-and 3-month follow up visits. | 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. | ClinicalTrials.gov |
| Secondary | Appendicular Skeletal Muscle Mass (ASMM) | At the 1-and 3-month follow up visits. | 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). | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)