NCT07447375 Exercise During Hemodialysis: Impact on Sarcopenia and Sleep Quality
| NCT ID | NCT07447375 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Salamanca |
| Condition | Sarcopenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 58 participants |
| Start Date | 2026-01-02 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 58 participants in total. It began in 2026-01-02 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Sarcopenia (the loss of muscle mass, strength, and function) is highly prevalent in patients with Chronic Kidney Disease (CKD) undergoing hemodialysis, significantly increasing the risk of falls, frailty, and mortality. Despite its impact, there is a lack of evidence regarding the effectiveness of exercise programs specifically designed to address sarcopenia under the latest international diagnostic criteria (EWGSOP2) in older renal patients. The primary objective of this randomized controlled clinical trial is to evaluate the effects of a 12-week supervised intrahospital exercise program on muscle mass, strength, and physical performance in hemodialysis patients over 40 years of age. Additionally, the study aims to analyze how this intervention influences sleep quality-often disrupted in this population-and overall health-related quality of life. Participants will be randomly assigned to either an Intervention Group, which will perform personalized strength and aerobic exercises during the first 90 minutes of their dialysis sessions, or a Control Group, receiving standard care. Evaluations will be conducted at three points: baseline (pre-randomization), at 12 weeks (post-intervention). The investigators hypothesize that integrating physical exercise into the routine clinical care of hemodialysis patients will improve sarcopenia markers and sleep patterns, leading to greater functional independence and better clinical outcomes.
Eligibility 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.
Contact & Investigator
María de la Luz Sánchez Tocino
STUDY DIRECTOR
University of Salamanca
Frequently Asked Questions
Who can join the NCT07447375 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Sarcopenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07447375 currently recruiting?
Yes, NCT07447375 is actively recruiting participants. Contact the research team at mlsancheztocino@usal.es for enrollment information.
Where is the NCT07447375 trial being conducted?
This trial is being conducted at Salamanca, Spain.
Who is sponsoring the NCT07447375 clinical trial?
NCT07447375 is sponsored by University of Salamanca. The principal investigator is María de la Luz Sánchez Tocino at University of Salamanca. The trial plans to enroll 58 participants.