Stretching Exercises for Dialysis Patients to Reduce Muscle Cramps

NCT07262879 | Completed

• 1 other identifier: FMBSUREC/01092024/Ali
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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). 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.

Conditions

Exercise Therapy; Nursing Care; Renal Dialysis; Muscle Cramp

Keywords

Nurse-led intervention; Intradialytic stretching; Hemodialysis symptoms; Muscle cramps; Exercise therapy; Non-pharmacological intervention; Symptom management; Proactive nursing care

Outcome Measures

Primary Outcomes (1)

• 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.

  8 weeks

Study Arms (2)

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.

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.

Interventions

Nurse-Led Intradialytic Stretching Exercises OTHER

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.

The intervention group (nurse-led intradialytic stretching exercises)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (2)

Beni-Suef University

Banī Suwayf, Beni Suweif Governorate, 62511, Egypt

Location

Beni-Suef University

Banī Suwayf, Beni Suweif Governorate, 62521, Egypt

Location

Related Publications (13)

• 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.

  PMID: 34762357 BACKGROUND

• Soliman 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.

  PMID: 40438027 BACKGROUND

• Sasirekha, 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

• 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.

  PMID: 38931320 BACKGROUND

• Miller 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.

  PMID: 34185846 BACKGROUND

• Miller 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.

  PMID: 24716521 BACKGROUND

• Kot 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.

  PMID: 39768954 BACKGROUND

• Kimmel 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.

  PMID: 10720966 BACKGROUND

• Hargrove 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.

  PMID: 33766925 BACKGROUND

• Gelfman 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.

  PMID: 39132460 BACKGROUND

• Alvarez 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.

  PMID: 32734233 BACKGROUND

• Alshammari 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.

  PMID: 40703153 BACKGROUND

• Shehata 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. doi: 10.1186/s12912-026-04430-4. Online ahead of print.

  PMID: 41803821 DERIVED

MeSH Terms

Conditions

Muscle Cramp

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Medical Surgical Nursing, faculty of Nursing, Beni-Suef University

Model Details: 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.

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 4, 2025
• Study Start: September 1, 2024
• Primary Completion: December 15, 2024
• Study Completion: January 1, 2025
• Last Updated: December 4, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Start Date: The IPD and supporting information will become available 3 months after the main results of the clinical trial are accepted for publication. End Date: The data will be made available for a period of 5 years from the start date.
• Access Criteria: Who can access: Researchers, including graduate students and investigators from academic institutions, healthcare organizations, and non-profit entities. Access will be granted to those with a methodologically sound proposal for use in achieving the goals outlined in their approved proposal. What they can access: Individual Participant Data (IPD): De-identified dataset including baseline characteristics, primary outcome (cramp intensity category), and all secondary outcomes (frequency, duration, pain, etc.). Supporting Information: The full Study Protocol and Statistical Analysis Plan (SAP). How they can access it: Mechanism: Data and documents will be shared via a secure file transfer service or a trusted data repository link upon approved request. Process: Interested parties must submit a formal request via email to the corresponding author (Ahmed Mostafa). Oversight: Requests will be reviewed by the study's principal investigators to ensure scientific validity \& ethical approval.

Locations

EG (2)