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Exercise During Hemodialysis: Impact on Sarcopenia and Sleep Quality

NCT07447375 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2026-03-03

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Gerencia Regional de Salud de Castilla y Leon

    collaborator OTHER

  • Instituto de Investigación Biomédica de Salamanca

    collaborator OTHER

  • University of Salamanca

    lead OTHER

Principal Investigators

  • María de la Luz Sánchez Tocino · University of Salamanca

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-02
Primary Completion
2026-12-31
Completion
2027-06-30

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07447375 on ClinicalTrials.gov