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.

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.

Study Overview

• Status: Recruiting
• Conditions: Renal Insufficiency, Chronic; Sarcopenia
• Intervention / Treatment: Behavioral: Intradialytic Personalized Exercise Program.

• Study Type: Interventional
• Enrollment (Estimated): 58
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: María de la Luz Sánchez Tocino, PhD; Phone Number: +34 625067971; Email: mlsancheztocino@usal.es

Study Locations

• Spain
  • Salamanca
    • Salamanca, Salamanca, Spain, 37008
      • Recruiting
      • Universidad de Salamanca
      • Contact: María de la Luz Sánchez Tocino, PhD; Phone Number: +34 625067971; Email: mlsancheztocino@usal.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 of cooperation (defined as failing to attend more than 25% of sessions) or inability to understand the treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No Intervention : Control group
Experimental: Experimental: Intervention Group; Intradialytic exercise program (strength and aerobic) 3 times weekly for 3 months.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
> Change in Upper Limb Muscle Strength measured by Handgrip Dynamometry.	> Muscle strength is assessed using a CAMRYR electronic dynamometer (Model EH101). The participant is in a standing position with the arm extended and parallel to the body. Maximum grip strength is measured over 3 seconds. Two attempts are made for each arm, and the highest value from the dominant arm (measured in kilograms) is recorded.	> Baseline, 12 weeks (post-intervention)
Change in Lower Limb Muscle Strength measured by the 5-Times Sit-to-Stand Test (STS5).	The STS5 test measures the time (in seconds) required for the patient to rise from a chair 5 consecutive times without arm support. It is a proxy for lower extremity muscle strength and power. A decrease in the time taken indicates an improvement in muscle function.	Baseline, 12 weeks (post-intervention)
Change in Appendicular Skeletal Muscle Mass (ASMM) measured by Bioelectrical Impedance Analysis (BIA).	Assessment of body composition and muscle mass using a portable BIA device. This method provides a validated estimate of muscle mass in both ambulatory and bedridden patients. The study focuses on the Appendicular Skeletal Muscle Mass (ASMM), which is essential for confirming a diagnosis of sarcopenia according to EWGSOP2 criteria. Higher values reflect greater muscle mass.	Baseline, 12 weeks (post-intervention)
Change in Physical Performance measured by the Short Physical Performance Battery (SPPB).	The SPPB is a composite score (0 to 12 points) evaluating balance, gait speed (4 meters), and the sit-to-stand test. A total score of 8 or less identifies patients with severe sarcopenia or high risk of frailty. Higher scores indicate better physical performance.	Baseline, 12 weeks (post-intervention)
Change in Sleep Quality measured by the Pittsburgh Sleep Quality Index (PSQI).	A self-administered questionnaire that assesses sleep quality over a 1-month time interval. It consists of 19 individual items, creating 7 components that yield one global score (range 0 to 21). Lower scores denote better sleep quality.	Baseline, 12 weeks (post-intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
> Change in Sarcopenia-related Quality of Life measured by the SarQoL® Questionnaire.	> The Sarcopenia Quality of Life (SarQoL®) is a self-administered questionnaire specifically developed for patients with sarcopenia. It consists of 22 questions covering 55 items across 7 domains: physical and mental health, mobility, body composition, function, activities of daily living, leisure activities, and fears. The total score ranges from 0 to 100, where higher scores indicate a better quality of life.	> Baseline, 12 weeks (post-intervention)
Objective Sleep Assessment via Wrist-worn Accelerometry (Actigraph).	Objective measurement of sleep-wake patterns using the Actigraph GT3X+ accelerometer. This device, worn on the wrist for 5 consecutive days, captures continuous data on circadian rhythms and physical activity. Using validated scoring algorithms via Actilife 6 software, the following statistics will be calculated: Total Sleep Time (TST), Sleep Efficiency (percentage of time in bed spent sleeping), and Wake After Sleep Onset (WASO).	Baseline, 12 weeks (post-intervention)
Change in Fat Mass Percentage measured by Bioelectrical Impedance Analysis (BIA).	Measurement of the total proportion of body fat relative to total body weight. This parameter is used to evaluate changes in body composition and to identify the presence of sarcopenic obesity in hemodialysis patients. A decrease in fat mass percentage is generally associated with improved metabolic health in this population.	Baseline, 12 weeks (post-intervention).
Change in Total Body Water (TBW) Percentage measured by Bioelectrical Impedance Analysis (BIA).	Evaluation of the percentage of total body water, including intracellular and extracellular compartments. In hemodialysis patients, this measure is crucial to ensure that changes in muscle mass measurements are not confounded by variations in hydration status or fluid overload between sessions.	Baseline, 12 weeks (post-intervention).

Collaborators and Investigators

• Sponsor: University of Salamanca
• Collaborators: Instituto de Investigación Biomédica de Salamanca; Gerencia Regional de Salud de Castilla y Leon
• Investigators: Study Director: María de la Luz Sánchez Tocino, University of Salamanca

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: February 12, 2026
• First Submitted That Met QC Criteria: February 27, 2026
• First Posted (Actual): March 3, 2026

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Quality of Life; Sleep Quality; Hemodialysis; Intradialytic Exercise
• Additional Relevant MeSH Terms: Urogenital Diseases; Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Mental Disorders; Pathologic Processes; Male Urogenital Diseases; Pathological Conditions, Anatomical; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Sleep Wake Disorders; Renal Insufficiency; Sleep Disorders, Intrinsic; Dyssomnias; Muscular Atrophy; Atrophy; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Sleep Initiation and Maintenance Disorders; Sarcopenia; Renal Insufficiency, Chronic
• Other Study ID Numbers: GRS 3142/A1/2024 (Other Grant/Funding Number: Gerencia Regional de Salud castilla y León, España)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No