Tokyo, Nov. 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059626) titled 'The Effect of Physical Activity on Postoperative Outcomes in Renal Transplant Patients' on Nov. 10.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Self control
Primary Sponsor:
Institute - Shonan Kamakura General Hospital(Clinical Research Center)
Condition:
Condition - Chronic Kidney Disease
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To measure Physical activity levels during hospitalization in kidney transplant patients using wearable devices and clarify the impact of activity levels on physical function at discharge and the occurrence of postoperative complications.
Basic objectives2 - Others
Intervention:
Interventions/Control_1 - Attach the device to the waist to measure activity levels. The patients wear it the day after surgery and keep it on at all times except during sleep and bathing. The wearing period is 10 days starting the day after surgery.
Postoperatively, standard rehabilitation interventions will be implemented for all subjects.
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1) Hospitalized patients undergoing Renal transplantation at our institution (regardless of underlying disease or prior dialysis history)
2) Patients aged 20 years or older at the time of consent acquisition (gender not restricted) (Note the subject's age when evaluating the IPAQ)
3) Research subjects who, after receiving sufficient explanation regarding participation in this study, provided written informed consent of their own free will
Key exclusion criteria - Patients meeting any of the following criteria shall not be included in this study:
1) Patients with a history of myocardial infarction
2) Patients with a history of coronary revascularization (PCI or CABG)
3) Patients with concomitant unstable angina
4) Patients with a history of cerebrovascular disease (excluding asymptomatic lacunar infarction)
5) Patients with a history of hospitalization due to heart failure
6) Patients with severe liver disease (AST (GOT) or ALT (GPT) 100U or more)
7) Women who are pregnant or may be pregnant
8) Women who are breastfeeding
9) Other patients deemed unsuitable as study subjects by the principal investigator.
Target Size - 70
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 06 Month 09 Day
Anticipated trial start date - 2025 Year 11 Month 10 Day
Last follow-up date - 2028 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068200
Disclaimer: Curated by HT Syndication.