Exercise during hemodialysis to prevent muscle loss and improve sleep

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized controlled trial enrolls patients aged 40+ who have been on chronic hemodialysis for more than three months and randomizes them to a 12-week personalized intradialytic exercise program or usual care. The intervention combines supervised strength and aerobic exercises tailored to each participant and is delivered during dialysis sessions at the hospital. Outcomes include changes in muscle mass, muscle strength (dynamometry), physical performance using contemporary EWGSOP2 sarcopenia criteria, sleep quality, and health-related quality of life. Hemodynamic stability, hemoglobin criteria, and common contraindications to exercise are used to screen participants prior to enrollment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Subjects currently enrolled in a Chronic Hemodialysis Unit.
* Patients who have been on hemodialysis treatment for more than 3 months.
* Subjects aged 40 years or older.
* Hemoglobin levels greater than 10 mg/dl.
* Ability to perform physical fitness assessment tests or dynamometry.
* Willingness and ability to provide signed informed consent

Exclusion Criteria:

* Presence of intradialytic instability.
* Medical conditions where exercise is contraindicated: active infectious process, neoplasms, uncontrolled arrhythmias, or left ventricular dysfunction (EF \< 35%).
* Musculoskeletal or respiratory alterations that worsen with exercise.
* Lower limb amputation without a prosthesis.
* Cerebrovascular disease (stroke with sequelae or transient ischemic attacks within the previous 6 weeks).
* Uncontrolled hypertension (Systolic BP \> 200 mmHg or Diastolic BP \> 120 mmHg).
* Unstable angina (at rest or during exercise) or history of coronary bypass/ischemic heart disease within the previous 6 weeks.
* Diabetes mellitus with severe decompensation (blood glucose \> 300 mg/dl).
* Dialysis-related hypotension (mean blood pressure \< 90/70 mmHg).
* Psychiatric or cognitive alterations that prevent collaboration with muscle training programs.
* Presence of an arteriovenous fistula in a lower limb.
* Motor neurological injury causing dysfunction that prevents the application of the strength protocol.
* Hospitalization within the 3 months prior to the study.
* Lack of cooperation (defined as failing to attend more than 25% of sessions) or inability to understand the treatment.

Where it's running

• Universidad de Salamanca
  Salamanca, Salamanca, Spain Recruiting

Study contacts

• Study coordinator: María de la Luz Sánchez Tocino, PhD
• Email: mlsancheztocino@usal.es
• Phone: +34 625067971

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.