Tokyo, May 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061246) titled 'A Multidimensional Investigation of Oral Frailty and Preventive Interventions' on May 1.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Kochi Medical School Hospital, Kochi University

Condition: Condition - healthy subjects Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Frailty, characterized by decreased muscle strength and physical activity, has been reported to significantly increase the risks of falls, disability, hospitalization, and mortality (Fried et al., 2001). It is also associated with depression and cognitive decline, leading to reduced quality of life (QOL). Although frailty is potentially reversible, delayed intervention may result in progression to sarcopenia and disability. Oral frailty (OF) refers to a state of impaired oral function, including eating and swallowing, which can lead to malnutrition. As a precursor to physical frailty, OF may progress to systemic frailty if left untreated. Therefore, early intervention at the OF stage is essential; however, the physical characteristics associated with OF remain unclear. This study aims to identify factors associated with OF from a multidimensional perspective, including physical function as well as pain and sleep disturbances. In addition, exercise-based interventions will be provided, and participants will be evaluated every six months to longitudinally examine their effects on the prevention and improvement of OF. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - After the baseline assessment, participants will receive interventions primarily consisting of educational lectures on oral frailty and frailty (using videos and slides) as well as exercise guidance (including demonstrations and printed materials). Subsequently, the same assessments will be conducted every six months to longitudinally examine changes in oral frailty and related factors, as well as the effects of the intervention.

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - Healthy community-dwelling residents who provided informed consent for participation in this study Key exclusion criteria - Individuals with cognitive impairment Individuals with a history of oral or head and neck surgery Individuals using a pacemaker Target Size - 100

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 05 Month 01 Day Anticipated trial start date - 2026 Year 05 Month 01 Day Last follow-up date - 2031 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070080

Disclaimer: Curated by HT Syndication.