Evaluating the effectiveness of stepwise swallowing training on dysphagia in patients with Alzheimer's disease: a study protocol for a randomized controlled trial

Abstract Background: The high prevalence of dysphagia among Alzheimer’s diseases (AD) has incurred many negative impacts. Therefore, effective and practicable dysphagia treatment are needed. As a fundamental rehabilitation of dysphagia, swallowing muscles exercises have received increased attention. Stepwise swallowing training (SST), integrated all swallowing organs movement, is expected to improve swallowing dysfunction among AD patients. By using randomized controlled trial design, the proposed study conducts a multi-center research to evaluate the effectiveness of SST program among AD patients.Methods: A multi-center randomized controlled trial, with a 4-week follow-up period after intervention, will be conducted among psychiatric hospitals in Guangdong, China. Participants in the control group will be assigned to routine dysphagia care, participants of the intervention group will undergo the same nursing care while additionally receive SST program. The SST program includes five sections of swallowing organs training: lip movement, facial movement, tongue movement, mandibular movement, and neck movement, respectively. Primary outcomes evaluate the swallowing function, including Water Swallowing Test (WTS) and Standard Swallowing Assessment (SSA). Secondary outcomes aim at measuring the improvement of negative impacts of dysphagia, including eating behavior, ability of daily activity, and nutritional status. Data will be collected at baseline (T0), at 2 weeks (T1, intervention completed), and at 4 weeks after intervention (T2, follow-up).Discussion: This study will offer trial-based evidence of the effectiveness of SST in relieving dysphagia among AD patients. SST program is expected to improve both the swallowing function and reduce negative impacts of dysphagia, with exploration of acceptability in SST program.Trial Registration: Chinese Clinical Trail Registry, ChiCTR2200056481. Prospectively registered on 6 February 2022, http://www.chictr.org.cn.