Effects of IOPI on Swallowing Function and Functional Status in Geriatric Patients

Study Overview
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Brief Summary
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This project is an exploratory study that aims to investigate the effects of IOPI therapy on the swallowing function and tongue strength of geriatric patients in a geriatric ward in an acute hospital. Its secondary aim is to investigate the correlation between IOPI readings and functional status. The result of this study could help to improve current practice of dysphagia intervention in the geriatric population. If results are significant, there will be research evidence to put forth a change to work processes for speech therapists. IOPI will be more widely used in the clinical context and will then result in better functional outcomes.

Detailed Description
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In recent years, there have been increasing evidence that tongue strengthening exercises have the ability to improve tongue muscle strength and tongue muscle thickness in the geriatric population. These improvements have a direct impact on the oral phase of swallow, specifically resulting in better orolingual manipulation and propulsion, and increasing intra-oral pressure for better bolus clearance. Reduction in tongue strength and other swallowing parameters can lead to swallowing disorder known as dysphagia. In the healthy ageing population, weakness in swallowing muscles is termed presbyphagia. Geriatric patients have an even higher chance of transitioning from presbyphagia to dysphagia when they become acutely unwell. Studies have also shown that deterioration of the whole-body muscle strength is associated with poorer oral function. Additionally, other studies have also shown that a lower isometric tongue strength might represent diminished functional reserves, which may increase the risk of dysphagia once an insult to the body occurs. There is also evidence that people who have episodes of aspiration have significantly weaker tongue strength at both the anterior and posterior regions. Thus, frail geriatric adults who have weaker skeletal muscles are at a higher risk of developing dysphagia. The tongue is amendable to therapy but current practices in Singapore lack an objective measure. Conventional dysphagia oromotor exercises employ the use of a tongue depressor. This method lacks a quantifiable measure to track outcome and is quite subjective to individual therapists. There is also a lack of practice guideline on recommended resistive load and frequency of exercise in the geriatric population in the acute setting. Other than outcome measures and practice guidelines, there is also a lack of research investigating the correlation of tongue strength and functional status. A few studies have explored the effects of different resistive load used in tongue strengthening exercises, although it was recommended to use a resistive load between 60% to 80% for more positive and extrinsic feedback, and for target population with a lower frustration threshold. Studies also used a longer timeframe of 3-4 weeks of rehabilitation to attain significant effects from skeletal muscle exercise. This, however, is not realistic in the acute geriatric setting in Singapore where the mean length of stay is 10 days. Thus, this study is an exploratory study to investigate the efficacy of using IOPI in this population to improve swallowing function and tongue strength. This study also aims to investigate if a correlation exists between IOPI reading and functional status.

Official Title
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Effects of IOPI on Swallowing Function and Functional Status in Geriatric Patients

Conditions
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Dysphagia

Intervention / Treatment
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* Device: IOPI Therapy
* Device: Tongue Depressor Traditional Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged 78-99 years old CFS rating of 4-7 able to sit out of bed able to follow at least 2-step directions (even for patients with cognitive condition e.g. dementia ) diagnosed with dysphagia by the ward speech therapist and assessed to be suitable for therapy have not been admitted for more than 2 days Exclusion Criteria: acute neurological conditions such as traumatic brain injury or stroke history of head and neck cancer, surgery or radiotherapy to head and neck region and 3) patients on long term tube feeding

Ages Eligible for Study
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Minimum Age: 78 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be randomized into control group or intervention group.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br>Tongue depressor exercise protocol for tongue strengthening for control group. Using the tongue depressor, participants will be prompted to stick their tongue out as much as they can and to push hard against the tongue depressor for 10 seconds. They will be required to repeat this action 10 times, constituting one set. They will be asked to perform 3 sets, with 30 secs of rest between each set. Arrange for 5 sessions for a week; sessions can take place on consecutive days. | Device: Tongue Depressor Traditional Intervention<br>* Using the tongue depressor, participants will be prompted to stick their tongue out as much as they can and to push hard against the tongue depressor for 10 seconds. They will be required to repeat this action 10 times, constituting one set. They will be asked to perform 3 sets, with 30 secs of rest between each set<br>|
| Experimental: Intervention Group<br>IOPI exercise protocol for tongue strengthening for intervention group. Using the IOPI, participants will perform 24 sets of 5 repetition at anterior position, allowing for 30 secs rest in between sets. Arrange for 5 sessions for a week; sessions can take place on consecutive days. | Device: IOPI Therapy<br>* Obtain IOPI reading at start of session, record the best of 3 readings as baseline strength. Calculate exercise resistance for session at 60% of baseline strength. Using the IOPI, participants will perform 24 sets of 5 repetition at anterior position, allowing for 30 secs rest in between sets.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of increase in tongue strength | The IOPI device will be used to measure tongue strength at the anterior position on the last day of intervention. This will be compared to the baseline tongue strength collected on the first day of intervention. | 5 intervention days | 
| Improvement in score on Functional Oral Intake Scale (FOIS) | The speech therapist will rate the participant's FOIS score at the start and end of intervention according to the type of diet that the participant is prescribed. | 5 intervention days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in AusTOMs Swallowing Scale Rating | The speech therapist will rate the participant on the AusTOMs swallowing scale at the beginning and end of intervention with accordance to the severity of dysphagia. | 5 intervention days | 
| Improvement in Modified Barthel Index (MBI) Score | The occupational therapist will provide a baseline and outcome rating on the MBI for each participant. This will contribute to the evaluation of the patient's functional status at the end of intervention. | 5 intervention days | 
| Improvement in hand grip strength (HGS) | The speech therapist administering the intervention will assess for hand grip strength at the beginning and end of intervention. This will contribute to the evaluation of the patient's functional status at the end of intervention. | 5 intervention days | 
| Improvement in timed sit-to-stand duration | The speech therapist administering the intervention will assess for timed sit-to-stand at the beginning and end of intervention. This will contribute to the evaluation of the patient's functional status at the end of intervention. | 5 intervention days | 
| Improvement in the score of the SARC-F questionnaire | The speech therapist administering the intervention will complete the questionnaire with the participant at the beginning and end of intervention. This will contribute to the evaluation of the patient's functional status at the end of intervention. | 5 intervention days | 
| Improvement in overall functional status. | The investigators of the study will compare the baseline and outcome measures for the AusTOMs swallowing scale rating, MBI, HGS, timed sit-to-stand and SARC-F scores to evaluate if participants show an improvement in their overall functional status. | 5 intervention days |