Exercise during hemodialysis to prevent muscle loss and improve sleep
Intrahospital Exercise Program in Hemodialysis Patients: Impact on Sarcopenia Markers, Sleep Quality, and Quality of Life.
This trial will test if a 12-week supervised exercise program performed during dialysis can improve muscle mass, strength, physical performance, sleep quality, and quality of life for patients aged 40 and over on chronic hemodialysis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 58 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | University of Salamanca Academic / other |
| Locations | 1 site (Salamanca, Salamanca) |
| Trial ID | NCT07447375 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 40 or older receiving chronic hemodialysis for at least three months who can perform basic fitness tests and give informed consent.
Not a fit: Patients with intradialytic instability, recent stroke, uncontrolled cardiac disease or arrhythmias, severe respiratory or musculoskeletal conditions that worsen with exercise, or lower limb amputation without a prosthesis are unlikely to benefit or may be excluded for safety.
Why it matters
Potential benefit: If successful, the program could help dialysis patients preserve or increase muscle mass and strength, reduce fall risk, and improve sleep and overall quality of life.
How similar studies have performed: Previous intradialytic exercise programs have shown improvements in strength, functional capacity, and quality of life, but applying the latest EWGSOP2 sarcopenia criteria in older hemodialysis patients is a relatively novel focus.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Salamanca, Salamanca
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.