Tokyo, Feb. 6 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060562) titled 'The Effect of "Kamikami Gokugoku Taiso" (a mastication and swallowing exercise) on Oral Function' on Feb. 5.

Study Type: Interventional

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

Primary Sponsor: Institute - The Lion Foundation for Dental Health

Condition: Condition - Oral frailty Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to verify the effects of performing "Kamikami Gokugoku Taiso" continuously for a certain period on improving oral function. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Intervention: Implementation of the "Kamikami Gokugoku Taiso" exercise. Frequency: Three times a day (e.g., before/after breakfast, lunch, and dinner). Volume: Six sets per session (approx. 20 minutes per session). Duration: Daily for approximately 2 months. Adherence monitoring: Participants will self-record their exercise implementation on a daily checklist.

Eligibility: Age-lower limit - 50 years-old = Gender - Male and Female Key inclusion criteria - 1.Individuals who have received a full explanation of the purpose and details of this study and have voluntarily provided written informed consent to participate. 2.Individuals who answered "yes" to one or both of the following questions on the Oral Frailty 5-item Checklist (OF-5): "Do you have more difficulty eating hard foods now than you did six months ago?" "Do you ever choke on tea or soup?" 3.Individuals who have not been certified as requiring long-term care or support (i.e., not receiving "Yo-kaigo" or "Yo-shien" certification). Key exclusion criteria - Dental-related criteria Individuals with complete dentures in both the maxilla and mandible. 2. Individuals currently undergoing orthodontic treatment. 3. Individuals receiving dental treatment that may affect oral function (excluding routine check-ups and cleanings). 4. Individuals who experience pain upon occlusion, making it difficult to perform the evaluations specified in this study. Systemic conditions and medical history 5. Individuals with poorly controlled systemic diseases (e.g., diabetes, liver disease, kidney disease, heart disease) that may affect the implementation of this study, or those who cannot obtain permission from their primary physician to participate. 6. Individuals with severe respiratory disease for whom swallowing training with a load is contraindicated as judged by a physician. Temporary conditions and medication history 7. Individuals with fever (e.g., 37.5C or higher) or symptoms suggestive of an acute infection at the time of each evaluation. 8. Individuals who have taken systemic antibiotics within one month prior to the baseline evaluation. Other 9. Individuals otherwise judged to be unsuitable for this study by the principal investigator. Target Size - 45

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 01 Month 28 Day Anticipated trial start date - 2026 Year 03 Month 01 Day Last follow-up date - 2026 Year 06 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069224

Disclaimer: Curated by HT Syndication.