Tokyo, Sept. 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063044) titled 'Fluid-Rest Balance Education for Interdialytic Weight Gain and Restless Legs Syndrome in Hemodialysis Patients' on Sept. 24.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Institut Teknologi dan Kesehatan Muhammadiyah Kalimantan Barat

Condition: Condition - Chronic Kidney Disease undergoing Hemodialysis Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To analyze the effect of Fluid-Rest Balance education on the reduction of interdialytic weight gain and restless legs syndrome in hemodialysis patients. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Fluid-Rest Balance education consists of four structured educational sessions, each lasting 15-20 minutes, delivered during the second to fifth scheduled hemodialysis treatments. Interventions/Control_2 - Fluid-Rest Balance booklet without structured educational sessions.

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key inclusion criteria - 1. Patients undergoing hemodialysis aged 18-60 years. 2. Undergoing hemodialysis for at least 3 months, with a frequency of 2-3 sessions per week. 3. No cognitive impairment based on the Mini-Mental State Examination (MMSE). 4. Experiencing Restless Legs Syndrome (RLS) symptoms based on clinical criteria of the International Restless Legs Syndrome Study Group (IRLSSG). 5. Having pre- and post-hemodialysis body weight records for at least the previous 2-4 weeks. Key exclusion criteria - 1. Participants who refuse to continue participation in the study. 2. Change of hemodialysis therapy to another renal replacement therapy, such as kidney transplantation or peritoneal dialysis. 3. Severe neurological disorders, including severe peripheral neuropathy, Parkinson's disease, or stroke. 4. Decreased level of consciousness or clinically unstable condition. 5. Comorbid conditions that may affect body fluid status, including a history of heart failure, diabetes mellitus, pulmonary edema, or pleural effusion. 6. Major changes in dopaminergic or antidepressant medication regimen within the previous 2-4 weeks. Target Size - 96

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 01 Month 26 Day Date of IRB - 2026 Year 02 Month 07 Day Anticipated trial start date - 2026 Year 10 Month 01 Day Last follow-up date - 2026 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072165

Disclaimer: Curated by HT Syndication.