The Effectiveness and Safety of Combined Research on Uremic Sarcopenia

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2026
Control Group: Received routine hemodialysis treatment. Sports Group: Receivedpre‐dialysis resistance training in addition to routine treatment.Combined Intervention Group: Received mindfulness meditation training during dialysis inaddition to exercise therapy.The study was designed as a single‐blind trial. The outcome assessors were blinded togroup allocation to reduce assessment bias, particularly in the evaluation of subjectivemeasures such as sleep quality, anxiety, and depression.Interventions and Methods: Including 4 parts: Part 1 comprehensive assessment andpreliminary education; Part 2 testing of one repetition maximum (1RM); Part 3pre‐dialysis resistance training; Part 4 mindfulness meditation training during dialysis.Comprehensive Assessment and Preliminary Education: Collection of general information(including gender, age, dialysis age, primary disease, etc.). Health education, dietaryguidance (calorie intake 30‐35kj/kg/d; protein intake 1.0‐1.2g/kg/d; maintain weight gainduring dialysis within 3%‐5% of dry weight). Establishment of a joint intervention team(including 2 meditation instructors, 1 rehabilitation therapist, 2 specialists, and 2nurses). One week before the trial, patients were introduced to the theoreticalknowledge, specific methods, and precautions of mindfulness meditation and PRT training.According to the "Expert Consensus on Exercise Rehabilitation for Chinese Adult Patientswith Chronic Kidney Disease" , all participants had no serious complications orcomorbidities and were all medium‐low risk patients who could undergo incrementalmoderate‐high intensity RT (1 RM 70‐85% exercise load).1RM Assessment: First, perform 5‐10 minutes of warm‐up exercises for the relevant musclegroups. Choose a weight close to the individual's maximum effort to overcome and begintesting, requiring the completion of 2 squatting movements. Gradually increase thebarbell weight in the order of 5kg, 2kg, and 1kg until only one squat can be completed.This weight is recorded as 1RM. Rest for 2‐3 minutes between each squat attempt.Resistance Training: Patients underwent resistance training in the hemodialysis center'sgym under the guidance of a rehabilitation therapist 1‐2 hours before each dialysissession. The RT prescription was formulated with reference to "the American College ofSports Medicine, ACSM Guidelines for Exercise Testing and Prescription (9th Edition)" andthe 2020 KDIGO Clinical Practice Guidelines to develop individualized exercise programs .The control group received routine dialysis treatment.Mindfulness Meditation Training: After starting dialysis and once blood pressure andheart rate stabilized (approximately 10 minutes), MHD patients were intervened upon usingmindfulness hemodialysis meditation audio developed by Lihuili Hospital [20].Observation Indicators and Methods:Exercise Capacity: CS‐30, HGS, 6MWT, 22StairsUpDownTime, TT10SU. The 30‐second chairstand test was used to assess lower limb muscle strength in the "sit‐to‐stand" statebefore and after 12 weeks of intervention. Patients crossed their arms over their chestand then performed rapid, continuous "stand up, sit down" movements for a limited time of30 seconds. The fewer the number of movements within 30 seconds, the worse the lower limbmuscle strength. HGS: Measured 3 times using a T.K.K 5001GRIP‐A grip strength meter(HKBG., Ltd, Sweden), and the average value was taken. 6MWT, time to climb up and down 22stairs, and time to stand up and sit down 10 times were measured before and after 12weeks of intervention. 6MWT: Performed according to the method reported by A.T.S .Subjects walked back and forth in a quiet and ventilated dialysis room corridor with alength of 30m, and the final 6MWT was measured. Time to climb up and down 22 stairs:Subjects continuously climbed up and down 22 stairs (vertical height of approximately3.3m) and the time taken was recorded. Time to stand up and sit down 10 times: Subjectsrepeatedly stood up and sat down from a standard‐height chair, and the time taken tostand up and sit down 10 times was recorded, and the average value was taken.Dynamic Balance Function (Timed Up and Go Test, TUGT): The "stand‐up and walk" test wasused. After the "start" command was issued, the subject stood up from a seated position(on a chair with a backrest), then walked forward 3m as quickly as possible, then turned180° around the 3m marker and quickly walked back to the chair and sat down with theirback against the backrest. The time taken for the entire process was recorded. The longerthe time taken, the worse the patient's dynamic balance function .Ultrasound Examination of the Quadriceps Femoris : The patient was placed in a supineposition with the upper body elevated 30°, and both legs were kept relaxed and straightwhile avoiding internal and external rotation of the hip and knee joints. The lineararray probe was placed vertically at approximately the lower 1/3 of the line connectingthe anterior superior iliac spine and the upper edge of the patella, keeping the soundbeam perpendicular to the femoral body and the probe pointing dorsally. The probeposition was adjusted to examine each muscle of the quadriceps femoris (including thecross‐sectional area of the rectus femoris, the thickness of the rectus femoris, and thethickness of the vastus intermedius) on the right thigh. The values of each parameter ofthe quadriceps femoris on the right thigh were measured three times at W0, W4, W8, andW12, and the average value was taken.5.4 Sleep, Anxiety, and Depression Scores: The Pittsburgh Sleep Quality Index (PSQI) ,Self‐Rating Anxiety Scale (SAS), and Self‐Rating Depression Scale (SDS) were used forevaluation .The psychometric properties (validity and reliability) of these scales have beenvalidated in populations similar to the study cohort, as referenced in previousliterature. Assessors were trained and underwent consistency checks to ensure reliableapplication of these scales.Laboratory Tests (Inflammatory Markers, Nutritional Markers, and Dialysis Adequacy):Fasting elbow venous blood was collected to measure interleukin‐6 (IL‐6),high‐sensitivity C‐reactive protein (Hs‐CRP), tumor necrosis factor (TNF), albumin (ALB),prealbumin (PA), adequacy index (KT/V), etc., before and after the intervention.Comparison of the occurrence of adverse reactions: Adverse events were monitoredthroughout the study. These included physical injuries from exercise, as well aspsychological distress related to the mindfulness meditation intervention. Adverse eventswere classified according to their severity and managed appropriately. A report andmonitoring mechanism was established for any serious adverse events.
Epistemonikos ID: 049ff6598063c85caf9ea10ca5d0f063049ccaae
First added on: Jul 25, 2026