NCT07203508

Effect of Tongue-to-Palate Resistance Training in Geriatric Patients With Oropharyngeal Dysphagia

Effect of Tongue-to-Palate Resistance Training on Penetration-Aspiration Scale and Suprahyoid Muscle Electrical Activity in Geriatric Patients With Oropharyngeal Dysphagia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Dr Cipto Mangunkusumo General Hospital · Academic / Other
• Sex: All
• Age: 61 Years
• Healthy volunteers: Not accepted

Summary

The goal of this randomized controlled trial is to learn if a home-based Tongue-to-Palate Resistance Training (TPRT) program can improve swallowing muscle activity and swallowing safety in geriatric patients (aged \>60 years) with oropharyngeal dysphagia. The main questions it aims to answer are: 1. Does TPRT increase the electrical activity of the suprahyoid muscles (a key muscle group for swallowing) more than standard care? 2. Does TPRT reduce scores on the Penetration-Aspiration Scale (PAS), a measure of swallowing safety, more than standard care? 3. Researchers will compare the TPRT intervention group to the active control group to see if the simple, home-based TPRT exercise is as effective or more effective than standard hospital-based therapies. Participants in the intervention group will: Perform the TPRT exercise (pressing their tongue against the palate) for 30 repetitions, 5 times a week, for 8 weeks at home. Be supported by a caregiver and use a video guide and logbook. Participants in the control group will: Receive standard hospital-based therapy twice a week, which may include Neuromuscular Electrical Stimulation (NMES) or biofeedback. Perform unsupervised Chin Tuck Against Resistance (CTAR) exercises at home. All participants will also receive education on safe swallowing techniques.

Detailed description

Title: Effect of Tongue-to-Palate Resistance Training on Penetration-Aspiration Scale and Suprahyoid Muscle Electrical Activity in Geriatric Patients with Oropharyngeal Dysphagia: A Randomized Control Trial Journal \& Type: This is a manuscript for publication, presenting the results of a single-blind, randomized controlled trial (RCT). Authors: The team is multi-disciplinary, consisting of experts in Internal Medicine, Physical Medicine and Rehabilitation (PM\&R), and Radiology from Cipto Mangunkusumo Hospital/University of Indonesia, and a collaborator from Germany. Background \& Rationale: Problem: Oropharyngeal dysphagia (difficulty swallowing) is a very common and serious problem in the elderly, leading to malnutrition, pneumonia from aspiration, and increased death rates. Current Solutions: Existing therapies (like Shaker exercises or electrical stimulation) can be difficult for frail elderly patients to perform or require clinic visits. Proposed Solution: Tongue-to-Palate Resistance Training (TPRT) is a simple, home-based exercise that could strengthen tongue and throat muscles, potentially improving swallowing. Preliminary studies showed it increases muscle activity, but robust evidence in geriatric patients was needed. Objective: To determine if an 8-week home-based TPRT program is effective at improving swallowing muscle activity (measured by electromyography/sEMG) and swallowing safety (measured by the Penetration-Aspiration Scale on videofluoroscopy) in elderly dysphagia patients. Methods: Design: Single-blind Randomized Controlled Trial (RCT). Participants: 20 elderly patients (\>60 years) with confirmed oropharyngeal dysphagia. They had to have low baseline muscle activity and an available caregiver. Intervention Group (n=9): Performed home-based TPRT (30 reps, 5x/week for 8 weeks) with video guidance and logbook monitoring. Control Group (n=8): Received standard care, which included clinic-based Neuromuscular Electrical Stimulation (NMES) or biofeedback twice a week plus unsupervised home exercises (Chin Tuck Against Resistance). Measurements: Primary Outcome 1: Suprahyoid Muscle Activity. Measured using surface electromyography (sEMG) at baseline, 4 weeks, and 8 weeks. Primary Outcome 2: Swallowing Safety. Measured using the Penetration-Aspiration Scale (PAS) via Videofluoroscopic Swallowing Study (VFSS) at baseline and 8 weeks. Secondary Outcomes: Hyoid bone movement (crucial for swallowing) and Pharyngeal Transit Time (PTT) were also measured from the VFSS. Analysis: Used advanced statistical tests (Repeated Measures ANOVA, Wilcoxon tests) to compare changes within and between groups over time.

Conditions

• Oropharyngeal Dysphagia
• Geriatric Patients

Interventions

Type	Name	Description
OTHER	Tongue-to-Palate Resistance Training	The Tongue-to-Palate Resistance Training (TPRT) is a home-based, device-free exercise program. Participants were instructed to press their tongue firmly against their hard palate and hold the contraction. The protocol consisted of 30 repetitions per session, performed five days a week for a duration of eight weeks. Adherence was supported through instructional videos, a caregiver, and a training logbook. The goal of the intervention is to strengthen the intrinsic and extrinsic tongue muscles and the suprahyoid muscle group to improve swallowing function.
COMBINATION_PRODUCT	Standard Dysphagia Therapy	The active comparator consists of a conventional, multi-modal standard of care for oropharyngeal dysphagia. It includes in-clinic sessions twice a week featuring either Neuromuscular Electrical Stimulation (NMES), where electrodes are placed in the submental region to stimulate the swallowing muscles, or biofeedback swallowing therapy. Additionally, participants perform unsupervised Chin Tuck Against Resistance (CTAR) exercises at home. This arm represents the established clinical rehabilitation approach against which the experimental TPRT intervention is compared

Timeline

• Start date: 2022-12-19
• Primary completion: 2024-11-25
• Completion: 2024-11-25
• First posted: 2025-10-02
• Last updated: 2025-10-02

Locations

1 site across 1 country: Indonesia