Exercise During Hemodialysis: Impact on Sarcopenia and Sleep Quality
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorUniversity of Salamanca
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Intradialytic Personalized Exercise Program.
BehavioralPersonalized 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.
Treatment groups
58 Participants
are divided into 2 treatment groupsGroup A: No Intervention : Control groupNo intervention 0 interventions
Group B: Experimental: Intervention GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
> 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.
Time frame
> Baseline, 12 weeks (post-intervention)2
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.
Time frame
Baseline, 12 weeks (post-intervention)3
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.
Time frame
Baseline, 12 weeks (post-intervention)4
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.
Time frame
Baseline, 12 weeks (post-intervention)Secondary outcomes
1
> 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.
Time frame
> Baseline, 12 weeks (post-intervention)2
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).
Time frame
Baseline, 12 weeks (post-intervention)3
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.
Time frame
Baseline, 12 weeks (post-intervention).4
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.
Time frame
Baseline, 12 weeks (post-intervention).Sponsors and contacts
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University of Salamanca
Lead sponsor
Gerencia Regional de Salud de Castilla y Leon
Collaborator
Instituto de Investigación Biomédica de Salamanca
Collaborator
Source ClinicalTrials.gov