Effect of Tongue-to-Palate Resistance Training in Geriatric Patients With Oropharyngeal Dysphagia
- Conditions
- Oropharyngeal DysphagiaGeriatric Patients
- Registration Number
- NCT07203508
- Lead Sponsor
- Dr Cipto Mangunkusumo General Hospital
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 17
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in Penetration-Aspiration Scale (PAS) Score Baseline and Week 8 Change in swallowing safety as measured by the Penetration-Aspiration Scale (PAS). The PAS is an 8-point ordinal scale. The minimum score is 1 (no airway invasion) and the maximum score is 8 (aspiration of material into the airway with no reflexive response). A lower score on the PAS indicates a safer swallow and is a better outcome.
Change in Suprahyoid Muscle Electrical Activity Baseline, Week 4, and Week 8 The change in the electrical activity of the suprahyoid muscles (measured in microvolts root mean square, μV RMS) during a tongue press task and a dry swallow task. Measured using surface electromyography (sEMG).
- Secondary Outcome Measures
Name Time Method Change in Anterior Hyoid Excursion Baseline and Week 8 The change in the distance of forward (anterior) movement of the hyoid bone during swallowing, expressed as a percentage of the C2-C4 vertebral distance. Measured from VFSS.
Change in Superior Hyoid Excursion Baseline and Week 8 The change in the distance of upward (superior) movement of the hyoid bone during swallowing, expressed as a percentage of the C2-C4 vertebral distance. Measured from VFSS.
Change in Pharyngeal Transit Time (PTT) Baseline and Week 8 The change in the time (in seconds) taken for the bolus to travel from the point where the bolus tail passes the ramus of the mandible to when it passes through the upper esophageal sphincter. Measured from VFSS.
Trial Locations
- Locations (1)
RSUPN Dr. Cipto Mangunkusumo
🇮🇩Jakarta Pusat, Jakarta Special Capital Region, Indonesia
RSUPN Dr. Cipto Mangunkusumo🇮🇩Jakarta Pusat, Jakarta Special Capital Region, Indonesia