Tokyo, Aug. 7 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062493) titled 'Study of the Effects of Intradialytic Exercise on Blood Biomarkers and Physical Function in Patients Undergoing Maintenance Hemodialysis' on Aug. 6.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Tsukuba University of Technology
Condition:
Condition - Patients undergoing maintenance hemodialysis (chronic kidney disease stage G5D)
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The objective of this prospective study is to investigate the effects of intradialytic exercise on circulating alpha-Klotho, FGF23, oxidative stress, vascular function, and physical function in patients undergoing maintenance hemodialysis. The study also aims to clarify the association between exercise-induced alpha-Klotho responses and redox phenotype, thereby elucidating the biological mechanisms underlying exercise responsiveness and providing a scientific basis for individualized exercise therapy.
Basic objectives2 - Others
Intervention:
Interventions/Control_1 - Participants will undergo a three month intradialytic exercise program. Aerobic exercise using a cycle ergometer will be performed during the first two hours of hemodialysis for 30 to 60 min per session, two to three times per week, at a Borg Rating of Perceived Exertion of 11 to 13. Exercise sessions will be supervised by a physical therapist, and exercise duration and workload will be adjusted according to each clinical condition and hemodynamic status.
Eligibility:
Age-lower limit - 50
years-old
Gender - Male and Female
Key inclusion criteria - 1 Patients undergoing maintenance hemodialysis three times per week for at least three months.
2 Clinically stable patients as judged by the attending nephrologist.
3 Patients capable of performing intradialytic exercise.
4 Patients who provided written informed consent.
Key exclusion criteria - 1 Acute infection or inflammatory disease.
2 Unstable cardiovascular disease.
3 Severe orthopedic or neurological disorders limiting exercise participation.
4 Active malignancy.
5 Hospitalization within the previous three months.
6 Any condition judged by the attending physician to interfere with safe participation in the study.
Target Size - 35
Recruitment Status:
Recruitment status - No longer recruiting
Date of protocol fixation - 2023 Year 11 Month 07 Day
Date of IRB - 2023 Year 11 Month 07 Day
Anticipated trial start date - 2025 Year 11 Month 01 Day
Last follow-up date - 2026 Year 02 Month 28 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071530
Disclaimer: Curated by HT Syndication.
