Tokyo, July 31 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058590) titled 'Effectiveness of Tongue Pressure Training with Biofeedback in Patients with Sarcopenic Dysphagia' on July 31.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - Heisei Medical Welfare Group Research Institute

Condition: Condition - Sarcopenia Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study aims to evaluate the effectiveness of tongue pressure training using biofeedback on improving tongue pressure and oral intake level in patients with sarcopenic dysphagia. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Biofeedback during tongue pressure training During a session, real-time feedback on tongue pressure is displayed on a computer screen. Three types of exercises are included: Maximal strength training, performed at >=80% of the participant's maximum tongue pressure. Accuracy training, performed at target levels of 70% of the maximum tongue pressure. Accuracy training, performed at target levels of 50% of the maximum tongue pressure. Isotonic tongue pressure exercises: three sets of ten repetitions for each exercise. Interventions/Control_2 - No biofeedback during tongue pressure training Three types of exercises are included: Maximal strength training, performed by exerting maximal tongue pressure. Accuracy training, performed based on the perceived effort corresponding to 70% of maximal tongue pressure. Accuracy training, performed based on the perceived effort corresponding to 50% of maximal tongue pressure. Isotonic tongue pressure exercises: three sets of ten repetitions for each exercise.

Eligibility: Age-lower limit - 65 years-old

Gender - Male and Female Key inclusion criteria - Admitted to a convalescent rehabilitation ward. Received a prescription for dysphagia rehabilitation by a speech-language therapist. Presence of sarcopenia, diagnosed according to the Asian Working Group for Sarcopenia (AWGS) 2019 criteria. A score of 5 or lower on the Functional Oral Intake Scale (FOIS). A Mini-Mental State Examination (MMSE) score of >=15. Key exclusion criteria - Presence of dysphagia caused by cerebrovascular disease, neuromuscular disease, or structural abnormalities. Medically unstable condition that makes it impossible to follow the training protocol. Expected length of stay in a convalescent rehabilitation ward of less than six weeks. Target Size - 88

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 06 Month 23 Day Date of IRB - 2025 Year 06 Month 23 Day Anticipated trial start date - 2025 Year 08 Month 01 Day Last follow-up date - 2027 Year 10 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066788

Disclaimer: Curated by HT Syndication.