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

Dr Cipto Mangunkusumo General Hospital

Status: Completed

Conditions: Oropharyngeal Dysphagia; Geriatric Patients

Treatments: Other: Tongue-to-Palate Resistance Training; Combination Product: Standard Dysphagia Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07203508

KET-1415/UN2.F1/ETIK/PPM.00.02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: All

Ages: 61+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 60 years with a diagnosis of oropharyngeal dysphagia based on history, physical examination, and Videofluoroscopic Swallowing Study (VFSS)
• Initial measurement of suprahyoid muscle electrical activity ≤ 37.1 µV RMS
• Has not undergone any other swallowing exercises or is not currently participating in any swallowing exercise program within the past 2 weeks.
• Cooperative and willing to participate in the study by signing the informed consent form after receiving an explanation
• Has a caregiver who is willing to participate and is cooperative to ensure the patient follows the exercise protocol according to the study.

Exclusion criteria

• Cognitive impairment in the domains of memory, attention, or language based on the Montreal Cognitive Assessment - Indonesian version (MoCA-Ina), which would prevent the subject from following exercise instructions.
• Presence of other conditions causing dysphagia, such as oral cavity malignancy, history of radical neck dissection, or history of chemoradiotherapy to the neck region less than 3 months after the last session.
• Complete inability to move the tongue or initial suprahyoid muscle electrical activity measurement = 0 µV.
• Allergy to barium, potato starch, corn starch, xanthan gum, dairy products, or latex.
• Use of a pacemaker.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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17 participants in 2 patient groups

Tongue-to-Palate Resistance Training (TPRT)

Experimental group

Description:

Participants in this arm performed a home-based Tongue-to-Palate Resistance Training (TPRT) program. The intervention consisted of pressing the tongue against the palate for 30 repetitions per session, five sessions per week, for a total of eight weeks. Participants were provided with video guidance and a logbook to record adherence, and were supported by a caregiver. This was a simple, device-free exercise regimen designed to strengthen the oropharyngeal and suprahyoid musculature.

Treatment:

Other: Tongue-to-Palate Resistance Training

Standard Dysphagia Therapy

Active Comparator group

Description:

Participants in this arm received the standard of care for oropharyngeal dysphagia. This included supervised, hospital-based sessions twice a week consisting of either Neuromuscular Electrical Stimulation (NMES) applied to the submental region or biofeedback swallowing therapy. Additionally, they were instructed to perform unsupervised Chin Tuck Against Resistance (CTAR) exercises at home. This arm represents the conventional, multi-modal rehabilitation approach against which the experimental TPRT intervention was compared.

Treatment:

Combination Product: Standard Dysphagia Therapy