Tokyo, Nov. 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059616) titled 'Validation of muscle function assessment on dialysis and non-dialysis days in patients with renal failure' on Nov. 2.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Self control

Primary Sponsor: Institute - Other

Condition: Condition - Hospitalized patients with chronic renal failure receiving maintenance dialysis Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Patients on hemodialysis typically undergo 4 hours of treatment three times per week. Consequently, dialysis days entail substantial time constraints patients are confined to bed during treatment and often report fatigue afterward, leading to reduced activity levels. This in turn predisposes to declines in activities of daily living (ADL) and quality of life (QOL) through deterioration of systemic metabolic function. With advancing age and longer dialysis vintage, overall physical activity also tends to decrease. It is well established among physiotherapists that exercise therapy for patients on dialysis can improve muscle strength, ADL, and QOL. However, clinical guidelines recommend low-intensity physiotherapy during the dialysis period, particularly on dialysis days, favoring conditioning or stretching. In practice, exercise therapy may be difficult to implement on dialysis days because patients frequently experience fatigue and difficulty generating force. Moreover, although systematic reviews have investigated the acute post-dialysis effects on lower-limb muscle function, consensus has not yet been reached. Therefore, in this study we will examine differences in quadriceps force generation between dialysis and non-dialysis days and evaluate the effects of exercise therapy, with the aim of clarifying dialysis-related differences in muscle function. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - On two consecutive days-one dialysis day (post-dialysis) and one non-dialysis day-fatigue at the same time of day will be assessed using a visual analogue scale (VAS) interview. Subsequently, isometric knee-extension strength will be measured five times with a handheld dynamometer. During these measurements, surface electromyography (sEMG) of the vastus medialis will be recorded simultaneously.

Eligibility: Age-lower limit - 18 years-old

Gender - Male and Female Key inclusion criteria - Patients with renal failure who were hospitalized at our institution and received dialysis between April 2023 and April 2026, and who meet all of the following inclusion criteria 1.A prescription for physical therapy issued by a rehabilitation physician. 2.Ability to understand the instructions. 3.No implanted pacemaker and no metallic implants in the thigh. 4.Age over 18 years. Key exclusion criteria - Patients in whom evaluation devices cannot be used because of infectious diseases or similar conditions. Target Size - 28

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2023 Year 08 Month 01 Day Date of IRB - 2023 Year 01 Month 06 Day Anticipated trial start date - 2023 Year 10 Month 01 Day Last follow-up date - 2025 Year 10 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068177

Disclaimer: Curated by HT Syndication.