Clinical trial NCT05074784: Effects of IOPI on Swallowing Function and Functional Status in Geriatric Patients
Official title: Effects of IOPI on Swallowing Function and Functional Status in Geriatric Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dysphagia
Lead sponsor: Khoo Teck Puat Hospital
Sponsor class: OTHER
Collaborators: name: National Healthcare Group, Singapore
First posted: 2021-10-12
Enrollment: 84
Sex: ALL
Minimum age (years): 78
Maximum age (years): 99
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized into control group or intervention group.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. aged 78-99 years old
2. CFS rating of 4-7
3. able to sit out of bed
4. able to follow at least 2-step directions (even for patients with cognitive condition e.g. dementia )
5. diagnosed with dysphagia by the ward speech therapist and assessed to be suitable for therapy
6. have not been admitted for more than 2 days

Exclusion Criteria:

1. acute neurological conditions such as traumatic brain injury or stroke
2. history of head and neck cancer, surgery or radiotherapy to head and neck region and 3) patients on long term tube feeding

Primary outcomes:
measure: Percentage of increase in tongue strength
timeFrame: 5 intervention days
measure: Improvement in score on Functional Oral Intake Scale (FOIS)
timeFrame: 5 intervention days
Secondary outcomes:
measure: Improvement in AusTOMs Swallowing Scale Rating
timeFrame: 5 intervention days
measure: Improvement in Modified Barthel Index (MBI) Score
timeFrame: 5 intervention days
measure: Improvement in hand grip strength (HGS)
timeFrame: 5 intervention days
measure: Improvement in timed sit-to-stand duration
timeFrame: 5 intervention days
measure: Improvement in the score of the SARC-F questionnaire
timeFrame: 5 intervention days
measure: Improvement in overall functional status.
timeFrame: 5 intervention days
Other outcomes:
Locations:
Study officials:
References:
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