Muscle CrampNCT07262879
Stretching Exercises for Dialysis Patients to Reduce Muscle Cramps
A study testing Nurse-Led Intradialytic Stretching Exercises in people with Muscle Cramp and Renal Dialysis, run by Beni-Suef University at 2 sites in Egypt.
Trial summary
This single-center, parallel-group randomized controlled trial aims to evaluate the effect of a nurse-led intradialytic stretching program on the burden of muscle cramps in patients receiving maintenance hemodialysis (HD). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Muscle Cramp, Renal Dialysis, Exercise Therapy
- What is being tested?
- Nurse-Led Intradialytic Stretching Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Sep 2024to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged 21 years or older.
- Undergoing maintenance hemodialysis on a thrice-weekly schedule.
- Have been on hemodialysis for at least 3 months.
- Clinically stable.
- Have a history of intradialytic lower-limb muscle cramps in the preceding month.
- Able to provide informed consent.
Who cannot join
- Musculoskeletal or neurological disorders that limit safe lower-limb stretching.
- Femoral vascular access or recent lower-limb vascular procedures.
- Undergoing their first or an emergency hemodialysis session.
- Inability to provide informed consent.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Beni-Suef University
Banī Suwayf, Beni Suweif Governorate, 62511
Beni-Suef University
Banī Suwayf, Beni Suweif Governorate, 62521
About this study
Official title: Effect of Nurse-Led Intradialytic Stretching Exercises on Muscle Cramp Burden Among Patients Undergoing Maintenance Hemodialysis: A Randomized Controlled Trial
This single-center, parallel-group randomized controlled trial aims to evaluate the effect of a nurse-led intradialytic stretching program on the burden of muscle cramps in patients receiving maintenance hemodialysis (HD). Sixty adult patients on thrice-weekly HD with a history of lower-limb cramps will be randomized 1:1 to either an intervention group or a usual care control group.
The intervention consists of a standardized protocol of supervised lower-limb stretches (ankle dorsiflexion, gastrocnemius, soleus, and hamstring stretches). Each stretch will be held for 20-30 seconds and repeated three times per limb. The protocol will be delivered by HD nurses during dialysis sessions, twice a week for a total of 15 sessions over approximately eight weeks. Fidelity will be monitored using a structured checklist. The control group will receive routine care without structured exercises.
The primary outcome is the post-intervention cramp intensity category, measured using the Arabic Muscle Cramp Severity and Characteristics Questionnaire (MC-SCQ). Secondary outcomes include cramp frequency, duration, pain intensity, leg temperature perception, and discomfort/functional interference.
Read the detailed description
- The Problem: The Burden of Intradialytic Muscle Cramps For patients undergoing maintenance hemodialysis (HD), the treatment is a life-sustaining necessity that comes with a significant symptom burden. Among the most common and disruptive of these symptoms are intradialytic muscle cramps-sudden, involuntary, and painful muscle contractions, primarily in the lower limbs. These episodes are not merely a minor inconvenience; they represent a serious clinical challenge. Cramps can be severe enough to forcibly halt a dialysis session, trigger distress calls to nurses, and necessitate urgent interventions such as sterile saline boluses or adjustments to the ultrafiltration rate. These reactive measures disrupt the dialysis process, can lead to hemodynamic instability, and increase nursing workload. For the patient, the experience is one of pain, anxiety, and a diminished quality of life. Estimates suggest these cramps affect a wide proportion, between 20% to 85%, of the chronic HD population.
- The Proposed Solution: A Proactive, Nurse-Led Intervention Traditional management of these cramps has largely been reactionary. This study proposes to test a paradigm shift: moving from reactive treatment to proactive, nurse-led prevention. The intervention under investigation is a standardized protocol of lower-limb stretching exercises, administered during the dialysis session (intradialytically). The rationale is grounded in exercise physiology: sustained stretching is believed to improve muscle flexibility, enhance local circulation, and modulate neuromuscular excitability, potentially raising the threshold at which a cramp is triggered. By leveraging the time patients are already connected to the dialysis machine and the constant presence of a nurse, this strategy offers a low-cost, non-pharmacological, and patient-centric approach that aligns with nursing values of health promotion and continuity of care.
- Study Design and Rigor To generate high-quality evidence, this study employs a single-center, parallel-group, randomized controlled trial (RCT) design. In this design, 60 eligible adult patients from the Beni-Suef University Hospital HD unit will be randomly assigned to one of two groups: The Intervention Group: Will receive the nurse-led intradialytic stretching program in addition to usual care. The Control Group: Will continue to receive usual care without any structured exercise program. This randomization process is intended to ensure that the groups are similar in all key aspects at the beginning of the study. To safeguard the integrity of the intervention, the research team will use a fidelity checklist to ensure every stretching session is delivered consistently and correctly.
- The Intervention in Detail The stretching protocol is designed to be both effective and feasible within a busy dialysis unit. It targets the primary muscle groups involved in cramps: the ankle dorsiflexors, gastrocnemius, soleus, and hamstrings. Execution: During the first 1-2 hours of their dialysis session, patients in the intervention group will perform a series of supervised stretches. Each stretch will be held for 20-30 seconds and repeated three times for each limb. Safety: A paramount concern is patient safety, particularly regarding the vascular access site. Nurses will be trained to ensure all stretches are performed away from the access arm, with no compromise to needle security or tubing. Dosage: The program will be administered twice a week for approximately eight weeks, totaling 15 supervised sessions.
- Measuring the Impact
The effect of the stretching program will be measured using the Arabic Muscle Cramp Severity and Characteristics Questionnaire (MC-SCQ). This tool is designed to capture the multi-dimensional burden of cramps by assessing:
Frequency of episodes Duration of cramps Pain Intensity Functional Interference and discomfort Leg Temperature Perception
Assessments will be conducted at baseline and at the end of the 8-week intervention period.
- Conditions
- Muscle Cramp, Renal Dialysis, Exercise Therapy, Nursing Care
- Being tested
- Nurse-Led Intradialytic Stretching Exercises
- Keywords
- Nurse-led intervention, Intradialytic stretching, Hemodialysis symptoms, Muscle cramps, Exercise therapy, Non-pharmacological intervention, Symptom management, Proactive nursing care
- Medical subject headings
- Muscle Cramp
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-Led Intradialytic Stretching ExercisesOther
Participants in the intervention group received a nurse-led, supervised intradialytic lower-limb stretching program. The standardized protocol was administered during the first 1-2 hours of hemodialysis sessions, twice a week, for a total of 15 sessions over approximately 8 weeks. The protocol consisted of four stretches targeting major lower-limb muscle groups: ankle dorsiflexion, gastrocnemius stretch, soleus stretch, and hamstring stretch. Each stretch was held for 20-30 seconds and repeated three times per limb. HD nurses, trained in the protocol and vascular access safety, delivered the intervention. Adherence and correct technique were monitored and documented for each session using a structured fidelity checklist.
| Study group | Role | What they receive |
|---|---|---|
| The intervention group (nurse-led intradialytic stretching exercises) | Experimental | This arm received a structured, nurse-led lower-limb stretching program in addition to their usual hemodialysis (HD) care. The intervention was designed to be a proactive, non-pharmacological strategy to prevent intradialytic muscle cramps. Receives: Other: Nurse-Led Intradialytic Stretching Exercises |
| The control group (usual care) | No intervention | This control arm received routine hemodialysis care without any structured exercise program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-intervention muscle cramp intensity category
Post-intervention muscle cramp intensity category, as measured by the Arabic Muscle Cramp Severity and Characteristics Questionnaire (MC-SCQ). The total MC-SCQ score (range 0-13) was mapped into a four-level ordinal categorical variable: None (0), Mild (1-4), Moderate (5-8), or Severe (9-13). The distribution of participants across these categories was compared between the study and control groups at the end of the 8-week intervention period.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start1 Sep 2024
- Primary completion15 Dec 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Muscle CrampStudies of the same condition, open and under way.
- More trials run by Beni-Suef 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
- Model description
- The study describes a "parallel-group randomized controlled trial" where participants were randomized into one of two distinct groups that received different interventions concurrently (study group vs. control group) for the duration of the study.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mostafa Shehata, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07262879
- Sponsor's protocol ID
- FMBSUREC/01092024/Ali
- Status last verified
- Dec 2025
- First submitted
- 20 Nov 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Baseline Characteristics: Age, sex, comorbidities, hemodialysis vintage, and baseline physiological parameters (e.g., blood pressure, calcium levels). Primary Outcome Data: Individual post-intervention cramp intensity category scores (None, Mild, Moderate, Severe) from the Arabic MC-SCQ questionnaire. Secondary Outcome Data: De-identified scores for all MC-SCQ sub-domains, including: Cramp frequency Cramp duration Pain intensity Discomfort/functional interference Leg temperature perception Intervention Data: Session-level adherence and fidelity checklist scores for participants in the intervention arm. This data will be stripped of all direct identifiers (e.g., name, medical record number) to protect participant confidentiality.
Publications
Takahashi A. The pathophysiology of leg cramping during dialysis and the use of carnitine in its treatment. Physiol Rep. 2021 Nov;9(21):e15114. doi: 10.14814/phy2.15114.
PubMed 34762357Soliman AR, Soliman KM, Abdelaziz TS, Ahmed RM, Abdellatif DA, Darwish RA, Abosaif N, Maamoun H, Hammad H, Zayed B, Fayed A, Abdelhamid YM, El-Khashab SO, Elkhatib M. The evolution of nephrology practice in Egypt: legacy, current challenges, and future directions-a narrative review. Ren Fail. 2025 Dec;47(1):2509784. doi: 10.1080/0886022X.2025.2509784. Epub 2025 May 29.
PubMed 40438027Sasirekha, C. (2017). Effectiveness of Intradialytic Stretching Exercise on Muscle Cramps among Patients Undergoing Haemodialysis at Selected Hospitals, Salem (Doctoral dissertation, Sri Gokulam College of Nursing, Salem).
Romeu-Perales M, Segura-Orti E, Cana-Poyatos A, Toquero-Correa M, Benavent-Caballer V, Pans-Alcaina D, Garcia-Maset R, Garcia-Testal A. The Effect of Intradialytic Exercise Using Virtual Reality on the Body Composition of Patients with Chronic Kidney Disease. Nutrients. 2024 Jun 20;16(12):1968. doi: 10.3390/nu16121968.
PubMed 38931320Miller KC, McDermott BP, Yeargin SW, Fiol A, Schwellnus MP. An Evidence-Based Review of the Pathophysiology, Treatment, and Prevention of Exercise-Associated Muscle Cramps. J Athl Train. 2022 Jan 1;57(1):5-15. doi: 10.4085/1062-6050-0696.20.
PubMed 34185846Miller KC, Burne JA. Golgi tendon organ reflex inhibition following manually applied acute static stretching. J Sports Sci. 2014;32(15):1491-7. doi: 10.1080/02640414.2014.899708. Epub 2014 Apr 9.
PubMed 24716521Kot G, Wrobel A, Kuna K, Makowka A, Nowicki M. The Effect of Muscle Cramps During Hemodialysis on Quality of Life and Habitual Physical Activity. Medicina (Kaunas). 2024 Dec 18;60(12):2075. doi: 10.3390/medicina60122075.
PubMed 39768954Kimmel PL, Varela MP, Peterson RA, Weihs KL, Simmens SJ, Alleyne S, Amarashinge A, Mishkin GJ, Cruz I, Veis JH. Interdialytic weight gain and survival in hemodialysis patients: effects of duration of ESRD and diabetes mellitus. Kidney Int. 2000 Mar;57(3):1141-51. doi: 10.1046/j.1523-1755.2000.00941.x.
PubMed 10720966Hargrove N, El Tobgy N, Zhou O, Pinder M, Plant B, Askin N, Bieber L, Collister D, Whitlock R, Tangri N, Bohm C. Effect of Aerobic Exercise on Dialysis-Related Symptoms in Individuals Undergoing Maintenance Hemodialysis: A Systematic Review and Meta-Analysis of Clinical Trials. Clin J Am Soc Nephrol. 2021 Apr 7;16(4):560-574. doi: 10.2215/CJN.15080920. Epub 2021 Mar 25.
PubMed 33766925Gelfman R, Ingraham BS, Sandhu GS, Lerman A, Lewis B, Gulati R, Pellikka PA, Higgins SD, Singh M. Stretching to Reduce Pain-Related Disability Among Echocardiographic and Interventional Laboratory Employees-A Pilot Study. J Soc Cardiovasc Angiogr Interv. 2024 May 2;3(5):101353. doi: 10.1016/j.jscai.2024.101353. eCollection 2024 May.
PubMed 39132460Alvarez L, Brown D, Hu D, Chertow GM, Vassalotti JA, Prichard S. Intradialytic Symptoms and Recovery Time in Patients on Thrice-Weekly In-Center Hemodialysis: A Cross-sectional Online Survey. Kidney Med. 2019 Dec 20;2(2):125-130. doi: 10.1016/j.xkme.2019.10.010. eCollection 2020 Mar-Apr.
PubMed 32734233Alshammari B, Edison JS, Alkubati SA, Alrasheeday AM, Albagawi B, Alharbi LL, Motakef HI, Alshammari L, Siam BGAE, Alharbi NA, Assiri W, Almoqad AA, Aldibas AI, Alshammari F. Effectiveness of exercise in reducing symptom burden among hemodialysis patients: a non-pharmacological intervention approach. Front Public Health. 2025 Jul 9;13:1580689. doi: 10.3389/fpubh.2025.1580689. eCollection 2025.
PubMed 40703153Shehata AM, Zaki WE, Ali HA, Weheida SM. Effect of nurse-led intradialytic stretching exercises on muscle cramp burden among patients undergoing maintenance hemodialysis: a randomized controlled trial. BMC Nurs. 2026 Mar 9;25(1):333. doi: 10.1186/s12912-026-04430-4.
PubMed 41803821
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nurse-Led Intradialytic Stretching Exercises on Muscle Cramp Burden Among Patients Undergoing Maintenance Hemodialysis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07262879
- Acronym / sponsor ID
- FMBSUREC/01092024/Ali
- Conditions
- Muscle Cramp, Renal Dialysis, Exercise Therapy, Nursing Care
- Keywords
- Nurse-led intervention, Intradialytic stretching, Hemodialysis symptoms, Muscle cramps, Exercise therapy, Non-pharmacological intervention, Symptom management, Proactive nursing care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 4 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This single-center, parallel-group randomized controlled trial aims to evaluate the effect of a nurse-led intradialytic stretching program on the burden of muscle cramps in patients receiving maintenance hemodialysis (HD). Sixty adult patients on thrice-weekly HD with a history of lower-limb cramps will be randomized 1:1 to either an intervention group or a usual care control group.
The intervention consists of a standardized protocol of supervised lower-limb stretches (ankle dorsiflexion, gastrocnemius, soleus, and hamstring stretches). Each stretch will be held for 20-30 seconds and repeated three times per limb. The protocol will be delivered by HD nurses during dialysis sessions, twice a week for a total of 15 sessions over approximately eight weeks. Fidelity will be monitored using a structured checklist. The control group will receive routine care without structured exercises.
The primary outcome is the post-intervention cramp intensity category, measured using the Arabic Muscle Cramp Severity and Characteristics Questionnaire (MC-SCQ). Secondary outcomes include cramp frequency, duration, pain intensity, leg temperature perception, and discomfort/functional interference.
Detailed description
- The Problem: The Burden of Intradialytic Muscle Cramps For patients undergoing maintenance hemodialysis (HD), the treatment is a life-sustaining necessity that comes with a significant symptom burden. Among the most common and disruptive of these symptoms are intradialytic muscle cramps-sudden, involuntary, and painful muscle contractions, primarily in the lower limbs. These episodes are not merely a minor inconvenience; they represent a serious clinical challenge. Cramps can be severe enough to forcibly halt a dialysis session, trigger distress calls to nurses, and necessitate urgent interventions such as sterile saline boluses or adjustments to the ultrafiltration rate. These reactive measures disrupt the dialysis process, can lead to hemodynamic instability, and increase nursing workload. For the patient, the experience is one of pain, anxiety, and a diminished quality of life. Estimates suggest these cramps affect a wide proportion, between 20% to 85%, of the chronic HD population.
- The Proposed Solution: A Proactive, Nurse-Led Intervention Traditional management of these cramps has largely been reactionary. This study proposes to test a paradigm shift: moving from reactive treatment to proactive, nurse-led prevention. The intervention under investigation is a standardized protocol of lower-limb stretching exercises, administered during the dialysis session (intradialytically). The rationale is grounded in exercise physiology: sustained stretching is believed to improve muscle flexibility, enhance local circulation, and modulate neuromuscular excitability, potentially raising the threshold at which a cramp is triggered. By leveraging the time patients are already connected to the dialysis machine and the constant presence of a nurse, this strategy offers a low-cost, non-pharmacological, and patient-centric approach that aligns with nursing values of health promotion and continuity of care.
- Study Design and Rigor To generate high-quality evidence, this study employs a single-center, parallel-group, randomized controlled trial (RCT) design. In this design, 60 eligible adult patients from the Beni-Suef University Hospital HD unit will be randomly assigned to one of two groups: The Intervention Group: Will receive the nurse-led intradialytic stretching program in addition to usual care. The Control Group: Will continue to receive usual care without any structured exercise program. This randomization process is intended to ensure that the groups are similar in all key aspects at the beginning of the study. To safeguard the integrity of the intervention, the research team will use a fidelity checklist to ensure every stretching session is delivered consistently and correctly.
- The Intervention in Detail The stretching protocol is designed to be both effective and feasible within a busy dialysis unit. It targets the primary muscle groups involved in cramps: the ankle dorsiflexors, gastrocnemius, soleus, and hamstrings. Execution: During the first 1-2 hours of their dialysis session, patients in the intervention group will perform a series of supervised stretches. Each stretch will be held for 20-30 seconds and repeated three times for each limb. Safety: A paramount concern is patient safety, particularly regarding the vascular access site. Nurses will be trained to ensure all stretches are performed away from the access arm, with no compromise to needle security or tubing. Dosage: The program will be administered twice a week for approximately eight weeks, totaling 15 supervised sessions.
- Measuring the Impact
The effect of the stretching program will be measured using the Arabic Muscle Cramp Severity and Characteristics Questionnaire (MC-SCQ). This tool is designed to capture the multi-dimensional burden of cramps by assessing:
Frequency of episodes Duration of cramps Pain Intensity Functional Interference and discomfort Leg Temperature Perception
Assessments will be conducted at baseline and at the end of the 8-week intervention period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study describes a "parallel-group randomized controlled trial" where participants were randomized into one of two distinct groups that received different interventions concurrently (study group vs. control group) for the duration of the study.
| Arm | Type | Receives |
|---|---|---|
| The intervention group (nurse-led intradialytic stretching exercises) | Experimental | Other: Nurse-Led Intradialytic Stretching ExercisesThis arm received a structured, nurse-led lower-limb stretching program in addition to their usual hemodialysis (HD) care. The intervention was designed to be a proactive, non-pharmacological strategy to prevent intradialytic muscle cramps. |
| The control group (usual care) | No intervention | –This control arm received routine hemodialysis care without any structured exercise program. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patients aged 21 years or older.
- Undergoing maintenance hemodialysis on a thrice-weekly schedule.
- Have been on hemodialysis for at least 3 months.
- Clinically stable.
- Have a history of intradialytic lower-limb muscle cramps in the preceding month.
Key exclusion criteria (4 listed)
- Musculoskeletal or neurological disorders that limit safe lower-limb stretching.
- Femoral vascular access or recent lower-limb vascular procedures.
- Undergoing their first or an emergency hemodialysis session.
- Inability to provide informed consent.
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 |
|---|---|---|
| Nurse-Led Intradialytic Stretching ExercisesParticipants in the intervention group received a nurse-led, supervised intradialytic lower-limb stretching program. The standardized protocol was administered during the first 1-2 hours of hemodialysis sessions, twice a week, for a total of 15 sessions over approximately 8 weeks. The protocol consisted of four stretches targeting major lower-limb muscle groups: ankle dorsiflexion, gastrocnemius stretch, soleus stretch, and hamstring stretch. Each stretch was held for 20-30 seconds and repeated three times per limb. HD nurses, trained in the protocol and vascular access safety, delivered the intervention. Adherence and correct technique were monitored and documented for each session using a structured fidelity checklist. | Other | The intervention group (nurse-led intradialytic stretching exercises) |
Primary outcome
Post-intervention muscle cramp intensity category
Time frame: 8 weeks
Post-intervention muscle cramp intensity category, as measured by the Arabic Muscle Cramp Severity and Characteristics Questionnaire (MC-SCQ). The total MC-SCQ score (range 0-13) was mapped into a four-level ordinal categorical variable: None (0), Mild (1-4), Moderate (5-8), or Severe (9-13). The distribution of participants across these categories was compared between the study and control groups at the end of the 8-week intervention period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Background: PubMed 34762357Takahashi A. The pathophysiology of leg cramping during dialysis and the use of carnitine in its treatment. Physiol Rep. 2021 Nov;9(21):e15114. doi: 10.14814/phy2.15114.
- Background: PubMed 40438027Soliman AR, Soliman KM, Abdelaziz TS, Ahmed RM, Abdellatif DA, Darwish RA, Abosaif N, Maamoun H, Hammad H, Zayed B, Fayed A, Abdelhamid YM, El-Khashab SO, Elkhatib M. The evolution of nephrology practice in Egypt: legacy, current challenges, and future directions-a narrative review. Ren Fail. 2025 Dec;47(1):2509784. doi: 10.1080/0886022X.2025.2509784. Epub 2025 May 29.
- BackgroundSasirekha, C. (2017). Effectiveness of Intradialytic Stretching Exercise on Muscle Cramps among Patients Undergoing Haemodialysis at Selected Hospitals, Salem (Doctoral dissertation, Sri Gokulam College of Nursing, Salem).
- Background: PubMed 38931320Romeu-Perales M, Segura-Orti E, Cana-Poyatos A, Toquero-Correa M, Benavent-Caballer V, Pans-Alcaina D, Garcia-Maset R, Garcia-Testal A. The Effect of Intradialytic Exercise Using Virtual Reality on the Body Composition of Patients with Chronic Kidney Disease. Nutrients. 2024 Jun 20;16(12):1968. doi: 10.3390/nu16121968.
- Background: PubMed 34185846Miller KC, McDermott BP, Yeargin SW, Fiol A, Schwellnus MP. An Evidence-Based Review of the Pathophysiology, Treatment, and Prevention of Exercise-Associated Muscle Cramps. J Athl Train. 2022 Jan 1;57(1):5-15. doi: 10.4085/1062-6050-0696.20.
- Background: PubMed 24716521Miller KC, Burne JA. Golgi tendon organ reflex inhibition following manually applied acute static stretching. J Sports Sci. 2014;32(15):1491-7. doi: 10.1080/02640414.2014.899708. Epub 2014 Apr 9.
- Background: PubMed 39768954Kot G, Wrobel A, Kuna K, Makowka A, Nowicki M. The Effect of Muscle Cramps During Hemodialysis on Quality of Life and Habitual Physical Activity. Medicina (Kaunas). 2024 Dec 18;60(12):2075. doi: 10.3390/medicina60122075.
- Background: PubMed 10720966Kimmel PL, Varela MP, Peterson RA, Weihs KL, Simmens SJ, Alleyne S, Amarashinge A, Mishkin GJ, Cruz I, Veis JH. Interdialytic weight gain and survival in hemodialysis patients: effects of duration of ESRD and diabetes mellitus. Kidney Int. 2000 Mar;57(3):1141-51. doi: 10.1046/j.1523-1755.2000.00941.x.
- Background: PubMed 33766925Hargrove N, El Tobgy N, Zhou O, Pinder M, Plant B, Askin N, Bieber L, Collister D, Whitlock R, Tangri N, Bohm C. Effect of Aerobic Exercise on Dialysis-Related Symptoms in Individuals Undergoing Maintenance Hemodialysis: A Systematic Review and Meta-Analysis of Clinical Trials. Clin J Am Soc Nephrol. 2021 Apr 7;16(4):560-574. doi: 10.2215/CJN.15080920. Epub 2021 Mar 25.
- Background: PubMed 39132460Gelfman R, Ingraham BS, Sandhu GS, Lerman A, Lewis B, Gulati R, Pellikka PA, Higgins SD, Singh M. Stretching to Reduce Pain-Related Disability Among Echocardiographic and Interventional Laboratory Employees-A Pilot Study. J Soc Cardiovasc Angiogr Interv. 2024 May 2;3(5):101353. doi: 10.1016/j.jscai.2024.101353. eCollection 2024 May.
- Background: PubMed 32734233Alvarez L, Brown D, Hu D, Chertow GM, Vassalotti JA, Prichard S. Intradialytic Symptoms and Recovery Time in Patients on Thrice-Weekly In-Center Hemodialysis: A Cross-sectional Online Survey. Kidney Med. 2019 Dec 20;2(2):125-130. doi: 10.1016/j.xkme.2019.10.010. eCollection 2020 Mar-Apr.
- Background: PubMed 40703153Alshammari B, Edison JS, Alkubati SA, Alrasheeday AM, Albagawi B, Alharbi LL, Motakef HI, Alshammari L, Siam BGAE, Alharbi NA, Assiri W, Almoqad AA, Aldibas AI, Alshammari F. Effectiveness of exercise in reducing symptom burden among hemodialysis patients: a non-pharmacological intervention approach. Front Public Health. 2025 Jul 9;13:1580689. doi: 10.3389/fpubh.2025.1580689. eCollection 2025.
- Individual participant dataSharing planned: Yes. Baseline Characteristics: Age, sex, comorbidities, hemodialysis vintage, and baseline physiological parameters (e.g., blood pressure, calcium levels). Primary Outcome Data: Individual post-intervention cramp intensity category scores (None, Mild, Moderate, Severe) from the Arabic MC-SCQ questionnaire. Secondary Outcome Data: De-identified scores for all MC-SCQ sub-domains, including: Cramp frequency Cramp duration Pain intensity Discomfort/functional interference Leg temperature perception Intervention Data: Session-level adherence and fidelity checklist scores for participants in the intervention arm. This data will be stripped of all direct identifiers (e.g., name, medical record number) to protect participant confidentiality.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-Led Intradialytic Stretching Exercises in people with Muscle Cramp and Renal Dialysis, run by Beni-Suef 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 6 inclusion and 4 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 4 Dec 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Post-intervention muscle cramp intensity category (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07262879, which also lists 13 linked publications.
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 4 Dec 2025.