HemodialysisNCT06079502
Electrical Muscle Stimulation Versus Resistive Training On Physical Measures, And Fatigue In Hemodialysis Patients
A study testing Neuromuscular Electrical Stimulation and resistive training program in people with Hemodialysis and Fatigue, run by Cairo University at 2 sites in Egypt.
Trial summary
The purpose of this randomized controlled trial is to compare the effects of intradialytic neuromuscular electrical stimulation (NMES) and intradialytic resistance exercise with usual care on physical function, dialysis adequacy, and fatigue in patients receiving maintenance hemodialysis. Read more about this study
- Who is it for?
- Ages 40 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemodialysis, Fatigue
- What is being tested?
- Neuromuscular Electrical Stimulation and resistive training program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesEgypt
- Study dates
- 20 Oct 2023to 30 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients of both sexes, with CKF on HD for more than 3 years.
- Age between 40 to 55 years old.
- BMI is between 25 and 29.9 kg/m2.
Who cannot join
- Patients who have one of the following contraindications to the interventions or affect the results
- Cognitive impairment that prevented them from performing the evaluations and who were unable to understand and sign the written informed consent.
- Stroke
- Smokers
- Anemic patients
- Osteoarticular or disabling musculoskeletal disorders
Show all 11Show fewer
- Uncontrolled hypertension (systolic blood pressure>230 mm Hg and diastolic blood pressure>120 mm Hg)
- Patients with coronary artery disease or heart failure.
- Diabetic patients
- Infectious diseases and chest diseases
- Active smokers' patients with peripheral vascular disease in the lower limbs such as deep vein thrombosis or thromboangiitis
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Nephrology and Dialysis Center, Kasr Al-Ainy Hospital, Cairo
Cairo
the Nephrology and Dialysis Center, Kasr Al-Ainy Hospital, Cairo, Egypt,
Dokki
About this study
The purpose of this randomized controlled trial is to compare the effects of intradialytic neuromuscular electrical stimulation (NMES) and intradialytic resistance exercise with usual care on physical function, dialysis adequacy, and fatigue in patients receiving maintenance hemodialysis. The study aims to evaluate whether these intradialytic rehabilitation interventions provide additional benefits compared with usual dialysis care.
Read the detailed description
his randomized controlled trial evaluates the effects of two intradialytic rehabilitation interventions, neuromuscular electrical stimulation (NMES) and resistance exercise, compared with usual care in patients receiving maintenance hemodialysis.
Participants were allocated to one of three groups: intradialytic NMES, intradialytic resistance exercise, or usual care. The rehabilitation interventions were performed during hemodialysis sessions. The usual-care group received routine dialysis care without the study rehabilitation interventions.
The study was conducted at the Nephrology and Dialysis Center, Kasr Al-Ainy Hospital, Cairo, Egypt. The study evaluates the effects of these interventions on physical function, dialysis adequacy, and fatigue.
The trial was initially registered as a two-group study. During implementation, a usual-care control group was added to provide an appropriate comparator for evaluating the effects of the two intradialytic rehabilitation interventions. The final study was therefore implemented as a three-group randomized controlled trial. The sample-size calculation was subsequently revised to account for the three-group design.
Dialysis adequacy was assessed using the urea reduction ratio (URR) rather than the Kt/V measure originally specified in the registration. This change was applied consistently across all study groups. The study-site information in the original registration was also corrected to reflect the actual recruitment and intervention site.
- Conditions
- Hemodialysis, Fatigue
- Being tested
- Neuromuscular Electrical Stimulation, resistive training program, usual care dialysis
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular Electrical StimulationDevice
A supervised program of intradialytic NMES of the quadriceps and calf muscles of both lower limbs with different phases, types and current intensity. The electrical stimulation program will included (total time, intensity, contraction-relaxation phase time): a toning program in the first two weeks.
resistive training programOther
Part one: Warming up for 5 minutes in the form of lower limbs range of motion (active free) exercise from supine position.
Part two: The main part is the resistive training for quadriceps and calf muscles from supine position using weights in the form of sand bags for 20 min.
Part three: Cooling down for 5 minutes in the form of lower limbs range of motion (active free) exercise from supine position.
The training parameters:
The exercise training will be done during the first 2 hours of HD session using free leg weights. The patient will assume a supine lying position on the treatment plinth and perform the exercises for every lower limb separately while the other limb will be supported on the plinth by therapist or the patient himself. Resistance will be placed at the malleoli level in the distal third of the leg.
usual care dialysisOther
Routine care provided during maintenance hemodialysis without the study-specific intradialytic neuromuscular electrical stimulation or resistance exercise intervention.
| Study group | Role | What they receive |
|---|---|---|
| Neuromuscular Electrical Stimulation group | Experimental | Thirty patients will receive a supervised program of intradialytic NMES two times per week for 16weeks with medical treatment. Receives: Device: Neuromuscular Electrical Stimulation |
| resistive training group | Experimental | Thirty patients will receive a supervised program of intradialytic resistive training two times per week for 16weeks with medical treatment. Receives: Other: resistive training program |
| Usual-care control | Other | Thirty patients will receive Routine care provided during maintenance hemodialysis without the study-specific intradialytic NMES or resistance exercise intervention. Receives: Other: usual care dialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing the Change in Maximal Strength of Quadriceps and Calf Muscles
By using a Hand held dynamometer: A Kern-type standardized traction dynamometer (Kern CH50 50KG dynamometer) will used to assess the maximal strength of quadriceps and calf muscles will estimate. The patient will remain seated in a fixed chair so the back will supported on the back rest with the hip and knee at 90°, the subject will be asked to exert the greatest possible force without holding the chair with his/her arms,the values of muscular strength variables will be the mean of 3 consecutive measurements obtained by the same investigator to minimize errors
Measured: at baseline and after 16 weeks of intervention
Assessing the Change in Predicted Peak vo2 Max
By using a 6-minute walk test (6MWT): It consisted of measuring the maximum distance covered during a 6 min period at an active pace, along a 20 m corridor near the HD unit. At the end of the test period, the total distance travelled was recorded by means of a standardized odometer,that will be used to calculate predicted peak vo2 by using the following equation Mean Peak VO2( ml /kg/min)= 4. 948+ 0. 023*Mean 6 MWD (meters) (SEE 1.1 ml/ kg/ min), standard error of estimate (SEE).
Measured: at baseline and after 16 weeks of intervention
Secondary outcomes (2)
Assessing the Change in Physical and Psychological Fatigue
Chalder Fatigue Questionnaire (CFQ11): is a short questionnaire, phrased in simple English with a straightforward answering system, it provides a brief tool to measure both physical and psychological fatigue. It consists from 11 items are answered on a 4-point scale ranging from the asymptomatic to maximum symptomology, a score of 0, increasing to 1, 2 or 3 as they become more symptomatic. The respondent's global score can range from 0 to 33. The global score also spans two dimensions physical fatigue (measured by items 1-7) and psychological fatigue (measured by items 8-11)
Measured: at baseline and after 16 weeks of intervention
Assessing the Change in Dialysis Efficiency
At baseline and 16 weeks after the intervention, blood samples will be collected after at least 12 h of fasting, and before the HD session, from an antecubital vein via venipuncture. Dialysis adequacy was assessed using the urea reduction ratio (URR) rather than Kt/V. URR was selected because predialysis and postdialysis blood urea nitrogen values were routinely available for all participants and permitted a consistent assessment of dialysis adequacy at both study time points. This approach was applied uniformly across all three groups.
Results for URR should be interpreted as those of the implemented analysis plan through this equation: URR(%)=Predialysis BUN-Postdialysis bun/Predialysis BUN*100
Measured: at baseline and after 16 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start20 Oct 2023
- Primary completion30 May 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Ibrahim Yacoub, Cairo University
- Investigators
- Asmaa Yacoub, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06079502
- Sponsor's protocol ID
- Asmaa_Yacoub
- Status last verified
- Aug 2026
- First submitted
- 6 Oct 2023
- Last updated
- 2 Nov 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to make individual participant-level data available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Muscle Stimulation Versus Resistive Training On Physical Measures, And Fatigue In Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT06079502
- Acronym / sponsor ID
- Asmaa_Yacoub
- Conditions
- Hemodialysis, Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 12 Oct 2023 (actual)
- Results
- Posted 2 Nov 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this randomized controlled trial is to compare the effects of intradialytic neuromuscular electrical stimulation (NMES) and intradialytic resistance exercise with usual care on physical function, dialysis adequacy, and fatigue in patients receiving maintenance hemodialysis. The study aims to evaluate whether these intradialytic rehabilitation interventions provide additional benefits compared with usual dialysis care.
Detailed description
his randomized controlled trial evaluates the effects of two intradialytic rehabilitation interventions, neuromuscular electrical stimulation (NMES) and resistance exercise, compared with usual care in patients receiving maintenance hemodialysis.
Participants were allocated to one of three groups: intradialytic NMES, intradialytic resistance exercise, or usual care. The rehabilitation interventions were performed during hemodialysis sessions. The usual-care group received routine dialysis care without the study rehabilitation interventions.
The study was conducted at the Nephrology and Dialysis Center, Kasr Al-Ainy Hospital, Cairo, Egypt. The study evaluates the effects of these interventions on physical function, dialysis adequacy, and fatigue.
The trial was initially registered as a two-group study. During implementation, a usual-care control group was added to provide an appropriate comparator for evaluating the effects of the two intradialytic rehabilitation interventions. The final study was therefore implemented as a three-group randomized controlled trial. The sample-size calculation was subsequently revised to account for the three-group design.
Dialysis adequacy was assessed using the urea reduction ratio (URR) rather than the Kt/V measure originally specified in the registration. This change was applied consistently across all study groups. The study-site information in the original registration was also corrected to reflect the actual recruitment and intervention site.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Neuromuscular Electrical Stimulation group | Experimental | Device: Neuromuscular Electrical StimulationThirty patients will receive a supervised program of intradialytic NMES two times per week for 16weeks with medical treatment. |
| resistive training group | Experimental | Other: resistive training programThirty patients will receive a supervised program of intradialytic resistive training two times per week for 16weeks with medical treatment. |
| Usual-care control | Other | Other: usual care dialysisThirty patients will receive Routine care provided during maintenance hemodialysis without the study-specific intradialytic NMES or resistance exercise intervention. |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients of both sexes, with CKF on HD for more than 3 years.
- Age between 40 to 55 years old.
- BMI is between 25 and 29.9 kg/m2.
Key exclusion criteria (11 listed)
- Patients who have one of the following contraindications to the interventions or affect the results
- Cognitive impairment that prevented them from performing the evaluations and who were unable to understand and sign the written informed consent.
- Stroke
- Smokers
- Anemic patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuromuscular Electrical StimulationA supervised program of intradialytic NMES of the quadriceps and calf muscles of both lower limbs with different phases, types and current intensity. The electrical stimulation program will included (total time, intensity, contraction-relaxation phase time): a toning program in the first two weeks. | Device | Neuromuscular Electrical Stimulation group |
| resistive training programPart one: Warming up for 5 minutes in the form of lower limbs range of motion (active free) exercise from supine position. Part two: The main part is the resistive training for quadriceps and calf muscles from supine position using weights in the form of sand bags for 20 min. Part three: Cooling down for 5 minutes in the form of lower limbs range of motion (active free) exercise from supine position. The training parameters: The exercise training will be done during the first 2 hours of HD session using free leg weights. The patient will assume a supine lying position on the treatment plinth and perform the exercises for every lower limb separately while the other limb will be supported on the plinth by therapist or the patient himself. Resistance will be placed at the malleoli level in the distal third of the leg. | Other | resistive training group |
| usual care dialysisRoutine care provided during maintenance hemodialysis without the study-specific intradialytic neuromuscular electrical stimulation or resistance exercise intervention. | Other | Usual-care control |
Primary outcome
Assessing the Change in Maximal Strength of Quadriceps and Calf Muscles
Time frame: at baseline and after 16 weeks of intervention
By using a Hand held dynamometer: A Kern-type standardized traction dynamometer (Kern CH50 50KG dynamometer) will used to assess the maximal strength of quadriceps and calf muscles will estimate. The patient will remain seated in a fixed chair so the back will supported on the back rest with the hip and knee at 90°, the subject will be asked to exert the greatest possible force without holding the chair with his/her arms,the values of muscular strength variables will be the mean of 3 consecutive measurements obtained by the same investigator to minimize errors
Assessing the Change in Predicted Peak vo2 Max
Time frame: at baseline and after 16 weeks of intervention
By using a 6-minute walk test (6MWT): It consisted of measuring the maximum distance covered during a 6 min period at an active pace, along a 20 m corridor near the HD unit. At the end of the test period, the total distance travelled was recorded by means of a standardized odometer,that will be used to calculate predicted peak vo2 by using the following equation Mean Peak VO2( ml /kg/min)= 4. 948+ 0. 023*Mean 6 MWD (meters) (SEE 1.1 ml/ kg/ min), standard error of estimate (SEE).
2 secondary outcomes
Assessing the Change in Physical and Psychological Fatigue
Time frame: at baseline and after 16 weeks of intervention
Assessing the Change in Dialysis Efficiency
Time frame: at baseline and after 16 weeks of intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. There are no plans to make individual participant-level data available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asmaa Yacoub principal investigator
Cairo University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular Electrical Stimulation and resistive training program in people with Hemodialysis and Fatigue, run by Cairo University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Nov 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing the Change in Maximal Strength of Quadriceps and Calf Muscles (time frame: at baseline and after 16 weeks of intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.