Actively Recruiting
Exercise During Hemodialysis: Impact on Sarcopenia and Sleep Quality
Led by University of Salamanca · Updated on 2026-03-03
58
Participants Needed
1
Research Sites
77 weeks
Total Duration
On this page
Sponsors
U
University of Salamanca
Lead Sponsor
G
Gerencia Regional de Salud de Castilla y Leon
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Exercise During Hemodialysis: Impact on Sarcopenia and Sleep Quality
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
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Trial Site Locations
Total: 1 location
1
Universidad de Salamanca
Salamanca, Salamanca, Spain, 37008
Actively Recruiting
Research Team
M
María de la Luz Sánchez Tocino, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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