Effect of the year-round simple swallowing training program in community-dwelling older people with mild oropharyngeal dysphagia: study protocol for a randomized controlled trial.

BACKGROUND

Oropharyngeal Dysphagia (OD) significantly affects the nutritional status and dysphagia-specific quality of life in older adults, and essentially increases the risk of aspiration. The Simple Swallowing Training Program (SSTP) is a user-friendly and safe behavioral intervention strategy. However, its long-term effects on swallowing and nutritional outcomes remain unclear. It is also unknown whether the SSTP can reduce the incidence of aspiration pneumonia and aspiratory cough during daily eating. This study aims to explore the effects of the SSTP on community-dwelling individuals aged 60 years and older with mild OD.

METHODS

This randomized controlled trial will involve 472 community-dwelling individuals aged 60 years and older. Participants will be randomized to either the SSTP or an active control group and will receive the respective intervention for one year. The primary outcome is swallowing function at 12 months, assessed using the Swallowing Outcome Severity Scale. Secondary outcomes include (1) airway protection at 12 months, assessed using the Penetration-Aspiration Scale; (2) malnutrition risk at 6 and 12 months, assessed using the Nutritional Risk Screening 2002; (3) dysphagia-specific quality of life; (4) self-reported OD risk at the first, sixth, and twelfth month, assessed using the Dysphagia Handicap Index and the 10-item Eating Assessment Tool; and (5) aspiratory cough and (6) aspiration pneumonia within 12 months post-randomization. DISCUSSION: The findings of this study will identify the short-term and long-term effects of the SSTP among community-dwelling older adults, and they will provide evidence-based support for the popularization of the SSTP to improve mild OD in the older population. TRIAL REGISTRATION: ClinicalTrials.gov. (Unique identifier: NCT07373028, 28/01/2026)