Tokyo, March 20 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060955) titled 'Effects of exercise intervention on immune function and physical performance in long term intermittent hemodialysis patients -pilot study-' on March 20.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Self control
Primary Sponsor:
Institute - Ibaraki Prefectural Central Hospital
Condition:
Condition - chronic kidney disease reated by dialysis
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - There is insufficient information on exercise intervention studies in long-term hemodialysis patients. Therefore, we aimed to clarify the effects of exercise therapy on cellular immunity, humoral immunity, nutritional status, and motor function in long-term hemodialysis patients.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Outpatient maintenance dialysis patients undergoing 6-hour dialysis three times a week underwent resistance exercise and aerobic exercise using an ergometer for a total of approximately 30 minutes during dialysis for 90 days.
Eligibility:
Age-lower limit - Not applicable
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Patients who have provided written informed consent to participate in this study.
Sex: no restriction (both male and female patients are eligible).
Age: 20 years or older at the time of consent.
Treatment setting: outpatient.
Patients undergoing maintenance hemodialysis for at least 6 months since initiation of dialysis, with a dialysis duration of 6 hours or longer per session.
Key exclusion criteria - Patients who are considered to have contraindications to exercise therapy based on a cardiac exercise stress test.
Patients with a history of hospitalization within the past 3 months.
Patients who are judged by the attending physician to be inappropriate for participation in this study for any other reason.
Target Size - 9
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2024 Year 10 Month 25 Day
Date of IRB - 2024 Year 10 Month 25 Day
Anticipated trial start date - 2024 Year 10 Month 25 Day
Last follow-up date - 2026 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064301
Disclaimer: Curated by HT Syndication.