Exercise During Hemodialysis: Impact on Sarcopenia and Sleep Quality

NCT07447375 | Recruiting

• 1 other identifier: GRS 3142/A1/2024
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Hemodialysis; Intradialytic Exercise; Sleep Quality; Quality of Life

Outcome Measures

Primary Outcomes (5)

• > 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 Outcomes (4)

• > Change in Sarcopenia-related Quality of Life measured by the SarQoL® Questionnaire.

  > Baseline, 12 weeks (post-intervention)

• Objective Sleep Assessment via Wrist-worn Accelerometry (Actigraph).

  Baseline, 12 weeks (post-intervention)

• Change in Fat Mass Percentage measured by Bioelectrical Impedance Analysis (BIA).

  Baseline, 12 weeks (post-intervention).

• Change in Total Body Water (TBW) Percentage measured by Bioelectrical Impedance Analysis (BIA).

  Baseline, 12 weeks (post-intervention).

Study Arms (2)

No Intervention : Control group

NO INTERVENTION

Experimental: Intervention Group

EXPERIMENTAL

Intradialytic exercise program (strength and aerobic) 3 times weekly for 3 months.

Behavioral: Intradialytic Personalized Exercise Program.

Interventions

Intradialytic Personalized Exercise Program. BEHAVIORAL

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.

Experimental: Intervention Group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

• 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.

Sponsors & Collaborators

• University of Salamanca: lead
• Gerencia Regional de Salud de Castilla y Leon: collaborator
• Instituto de Investigación Biomédica de Salamanca: collaborator

Study Sites (1)

Universidad de Salamanca

Salamanca, Salamanca, 37008, Spain

RECRUITING

MeSH Terms

Conditions

Sarcopenia; Renal Insufficiency, Chronic; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders

Study Officials

• María de la Luz Sánchez Tocino

  University of Salamanca

  STUDY DIRECTOR

Central Study Contacts

María de la Luz Sánchez Tocino, PhD

CONTACT

+34 625067971; mlsancheztocino@usal.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd, Associate profesor

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: March 3, 2026
• Study Start: January 2, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)