Tokyo, Sept. 21 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062958) titled 'Combined exercise and nutritional intervention in patients undergoing maintenance hemodialysis with cachexia: A pilot study' on Sept. 21.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Yokohama City University
Condition:
Condition - End-stage kidney disease on maintenance hemodialysis with cachexia
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To exploratively evaluate the effectiveness of a combined exercise and nutritional intervention for improving cachexia-related symptoms in patients with end-stage kidney disease undergoing maintenance hemodialysis.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Participants will receive a 3-month nutritional intervention using an oral nutritional supplement (ENEVO) to achieve a protein intake of 1.2 g/kg/day. In addition, aerobic exercise using an adjustable-load cycle ergometer will be performed during outpatient hemodialysis for 30 minutes per session, three times per week, for 3 months. Exercise intensity will be adjusted to approximately 13 on the Borg Rating of Perceived Exertion Scale.
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1. Patients aged 18 years or older at the time of enrollment.
2. Patients with end-stage kidney disease undergoing outpatient maintenance hemodialysis who have cachexia.
3. Patients who have received sufficient explanation about the study and provided written informed consent.
Key exclusion criteria - 1. Patients with physical or cognitive impairments that may interfere with the conduct of the study.
2. Patients with malignancies or medical conditions requiring active treatment.
3. Patients receiving steroid therapy.
4. Patients in poor general condition with an expected prognosis limited to several months.
5. Patients considered unsuitable for participation in the study by the attending physician.
Target Size - 12
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 04 Month 03 Day
Anticipated trial start date - 2026 Year 10 Month 01 Day
Last follow-up date - 2027 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072082
Disclaimer: Curated by HT Syndication.
