Stretching Exercises for Dialysis Patients to Reduce Muscle Cramps

December 2, 2025 updated by: Ahmed Mostafa Shehata, Beni-Suef University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  1. 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.
  2. 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.

  3. 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.

  4. 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.

  5. 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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Beni Suweif Governorate
      • Banī Suwayf, Beni Suweif Governorate, Egypt, 62521
        • Beni-Suef University
      • Banī Suwayf, Beni Suweif Governorate, Egypt, 62511
        • Beni-Suef University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The intervention group (nurse-led intradialytic stretching exercises)
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
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.
No Intervention: The control group (usual care)
This control arm received routine hemodialysis care without any structured exercise program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beni-Suef University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2024

Primary Completion (Actual)

December 15, 2024

Study Completion (Actual)

January 1, 2025

Study Registration Dates

First Submitted

November 20, 2025

First Submitted That Met QC Criteria

December 2, 2025

First Posted (Estimated)

December 4, 2025

Study Record Updates

Last Update Posted (Estimated)

December 4, 2025

Last Update Submitted That Met QC Criteria

December 2, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMBSUREC/01092024/Ali

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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