Exercise During Hemodialysis: Impact on Sarcopenia and Sleep Quality (NCT07447375) | Clinical Trial Compass
RecruitingNot Applicable
Exercise During Hemodialysis: Impact on Sarcopenia and Sleep Quality
Spain58 participantsStarted 2026-01-02
Plain-language 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.
Who can participate
Age range
40 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:
* 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…
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
1
> Change in Upper Limb Muscle Strength measured by Handgrip Dynamometry.