Tokyo, Sept. 13 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059053) titled 'Research on the relationship between physical function, malnutrition, and swallowing function' on Sept. 11.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Tezukayama University
Condition:
Condition - Frail elderly subjects
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To investigate the relationship between physical function and physical activity and feeding and swallowing function in order to prevent aspiration pneumonia.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Evaluate based on items related to physical function, malnutrition status, and swallowing function.
Eligibility:
Age-lower limit - 65
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Hospitalized patients aged 65 and over
Key exclusion criteria - A. Individuals requiring treatment such as enteral nutrition or parenteral nutrition
B. Individuals with severe dysphagia unable to ingest orally
C. Individuals with a Japan Coma Scale (JCS) level of II-2 or higher
D. Individuals experiencing frequent episodes of poor health
E. Individuals within 12 months of cerebrovascular disease onset
F. Individuals unable to understand the study explanation (however, they may be included if consent is obtained from a proxy; if the participant shows signs or actions indicating refusal, their
Target Size - 300
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 04 Month 22 Day
Date of IRB - 2025 Year 06 Month 17 Day
Anticipated trial start date - 2025 Year 09 Month 11 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=R000067547
Disclaimer: Curated by HT Syndication.
