About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Intradialytic Personalized Exercise Program.
Treatment groups
Sponsors and collaborators
University of Salamanca
Lead sponsor
Gerencia Regional de Salud de Castilla y Leon
Collaborator
Instituto de Investigación Biomédica de Salamanca
Collaborator