CompletedNot Applicable

Stretching Exercises for Dialysis Patients to Reduce Muscle Cramps

Egypt60 participantsStarted 2024-09-01

Plain-language 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.

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Post-intervention muscle cramp intensity category

Timeframe: 8 weeks

Trial details

NCT IDNCT07262879

SponsorBeni-Suef University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-15

View on ClinicalTrials.gov More Muscle Cramp trials