NCT07447375

Exercise During Hemodialysis: Impact on Sarcopenia and Sleep Quality

Intrahospital Exercise Program in Hemodialysis Patients: Impact on Sarcopenia Markers, Sleep Quality, and Quality of Life.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: University of Salamanca · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sarcopenia
• Renal Insufficiency, Chronic

Interventions

Type	Name	Description
BEHAVIORAL	Intradialytic Personalized Exercise Program.	Personalized intradialytic exercise program performed during the first 30 minutes of the hemodialysis session once the patient is hemodynamically stable. The intervention lasts 12 weeks with 2-3 sessions per week, supervised by physiotherapists. Each session (max. 60 min) includes: 1) Respiratory and joint mobility warm-up; 2) Strength training for lower limbs (hip flexors, extensors, abduction/adduction, and ankle movements) using elastic bands, weighted ankle straps, foam balls, and Pilates rings; 3) Aerobic resistance using a bed-cycle ergometer. Intensity is adjusted progressively to 12-14 on the Borg Scale (range 6-20). The program follows training principles, increasing volume and intensity over time to improve muscle mass, strength, and physical performance.

Timeline

• Start date: 2026-01-02
• Primary completion: 2026-12-31
• Completion: 2027-06-30
• First posted: 2026-03-03
• Last updated: 2026-03-03

Locations

1 site across 1 country: Spain