Abstract：
BACKGROUND: The high prevalence of dysphagia among Alzheimer\'s disease (AD) patients has become a public health and economic concern. Therefore, effective and accessible dysphagia treatments are needed. As a fundamental rehabilitation of dysphagia, swallowing muscle exercises have received increased attention. Stepwise swallowing training (SST), integrated with all swallowing organs movement, is expected to improve swallowing dysfunction among AD patients. By using a randomized controlled trial design, we propose a multi-center research to evaluate the effectiveness of SST program among AD patients.
METHODS: A multi-center exploratory randomized controlled trial, with a 4-week follow-up period, will be conducted in three major public psychiatric hospitals in Guangdong, China. Participants in the control group will be assigned to routine dysphagia care, while participants in the intervention group will undergo the same nursing care and additionally receive the SST program. The SST program includes five sections of swallowing organs training: lip movement, facial movement, tongue movement, mandibular movement, and neck movement. Primary outcomes evaluate the swallowing function, namely, Water Swallowing Test (WTS) and Standard Swallowing Assessment (SSA). Secondary outcomes aim at measuring the improvement of negative impacts of dysphagia, namely eating behavior, ability of daily activity, and nutritional status. Data will be collected at baseline (T1), at 2 weeks (T2, intervention), and 4 weeks after intervention (T3, follow-up).
CONCLUSIONS: 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 the negative impacts of dysphagia, with an exploration of acceptability in the SST program.
BACKGROUND: Chinese Clinical Trial Registry, ChiCTR2200056481 . Prospectively registered on 6 February 2022.
METHODS: A multi-center exploratory randomized controlled trial, with a 4-week follow-up period, will be conducted in three major public psychiatric hospitals in Guangdong, China. Participants in the control group will be assigned to routine dysphagia care, while participants in the intervention group will undergo the same nursing care and additionally receive the SST program. The SST program includes five sections of swallowing organs training: lip movement, facial movement, tongue movement, mandibular movement, and neck movement. Primary outcomes evaluate the swallowing function, namely, Water Swallowing Test (WTS) and Standard Swallowing Assessment (SSA). Secondary outcomes aim at measuring the improvement of negative impacts of dysphagia, namely eating behavior, ability of daily activity, and nutritional status. Data will be collected at baseline (T1), at 2 weeks (T2, intervention), and 4 weeks after intervention (T3, follow-up).
CONCLUSIONS: 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 the negative impacts of dysphagia, with an exploration of acceptability in the SST program.
BACKGROUND: Chinese Clinical Trial Registry, ChiCTR2200056481 . Prospectively registered on 6 February 2022.
摘要：
背景：阿尔茨海默病（AD）患者吞咽困难的高患病率已成为公共卫生和经济问题。因此,需要有效和容易获得的吞咽困难治疗。作为吞咽困难的基本康复，吞咽肌肉锻炼受到越来越多的关注。逐步吞咽训练（SST）与所有吞咽器官的运动相结合，有望改善AD患者的吞咽功能障碍。通过使用随机对照试验设计，我们提出了一项多中心研究来评估AD患者SST计划的有效性.
方法：多中心探索性随机对照试验，为期4周的随访期，将在广东三大公立精神病医院进行,中国。对照组的参与者将被分配到常规吞咽困难护理，而干预组的参与者将接受相同的护理，并额外接受SST计划。SST计划包括吞咽器官训练的五个部分：嘴唇运动，面部运动,舌头运动,下颌运动,颈部运动。主要结果评估吞咽功能，即,水吞咽测试(WTS)和标准吞咽评估(SSA)。次要结果旨在衡量吞咽困难的负面影响的改善，即饮食行为，日常活动能力，和营养状况。数据将在基线(T1)收集，在2周（T2，干预），干预后4周（T3，随访）。
结论：本研究将提供基于试验的证据，证明SST在缓解AD患者吞咽困难方面的有效性。SST计划有望改善吞咽功能并减少吞咽困难的负面影响，探索SST计划的可接受性。
背景：中国临床试验注册中心，ChiCTR2200056481。2022年2月6日登记。
方法：多中心探索性随机对照试验，为期4周的随访期，将在广东三大公立精神病医院进行,中国。对照组的参与者将被分配到常规吞咽困难护理，而干预组的参与者将接受相同的护理，并额外接受SST计划。SST计划包括吞咽器官训练的五个部分：嘴唇运动，面部运动,舌头运动,下颌运动,颈部运动。主要结果评估吞咽功能，即,水吞咽测试(WTS)和标准吞咽评估(SSA)。次要结果旨在衡量吞咽困难的负面影响的改善，即饮食行为，日常活动能力，和营养状况。数据将在基线(T1)收集，在2周（T2，干预），干预后4周（T3，随访）。
结论：本研究将提供基于试验的证据，证明SST在缓解AD患者吞咽困难方面的有效性。SST计划有望改善吞咽功能并减少吞咽困难的负面影响，探索SST计划的可接受性。
背景：中国临床试验注册中心，ChiCTR2200056481。2022年2月6日登记。
