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

Dysphagia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05074784
• Other study ID #: 2021/00223
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: November 1, 2022

Study information

• Verified date: September 2021
• Source: Khoo Teck Puat Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 84
• Est. completion date: November 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 78 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia

Intervention

Device:
• IOPI Therapy
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.
• Tongue Depressor Traditional Intervention
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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Khoo Teck Puat Hospital	National Healthcare Group, Singapore

References & Publications (12)

Adams V, Mathisen B, Baines S, Lazarus C, Callister R. Reliability of measurements of tongue and hand strength and endurance using the Iowa Oral Performance Instrument with elderly adults. Disabil Rehabil. 2015;37(5):389-95. doi: 10.3109/09638288.2014.921245. Epub 2014 May 22. — View Citation

Aoki, Y., Kabuto, S., Ozeki, Y., Tanaka, T., amp; Ota, K. (2015). The effect of tongue pressure strengthening exercise for dysphagic patients. Japanese Journal of Comprehensive Rehabilitation Science, 6, 129-136.

Butler SG, Stuart A, Leng X, Wilhelm E, Rees C, Williamson J, Kritchevsky SB. The relationship of aspiration status with tongue and handgrip strength in healthy older adults. J Gerontol A Biol Sci Med Sci. 2011 Apr;66(4):452-8. doi: 10.1093/gerona/glq234. Epub 2011 Feb 7. — View Citation

Kim, S., Kim, M., Lee, S., Choi, B., amp; Heo, Y. (2019). The Effects of Orofacial Myofunctional Training on the Changes of Lip and Tongue Strength in Elderly People. Journal of Dental Hygiene Science, 19(4), 279-287. doi:https://doi.org/10.17135/jdhs.2019.19.4.279

Namasivayam-MacDonald AM, Riquelme LF. Presbyphagia to Dysphagia: Multiple Perspectives and Strategies for Quality Care of Older Adults. Semin Speech Lang. 2019 Jun;40(3):227-242. doi: 10.1055/s-0039-1688837. Epub 2019 Jun 3. Review. — View Citation

Park JS, Lee SH, Jung SH, Choi JB, Jung YJ. Tongue strengthening exercise is effective in improving the oropharyngeal muscles associated with swallowing in community-dwelling older adults in South Korea: A randomized trial. Medicine (Baltimore). 2019 Oct;98(40):e17304. doi: 10.1097/MD.0000000000017304. — View Citation

Sagawa K, Furuya H, Ohara Y, Yoshida M, Hirano H, Iijima K, Kikutani T. Tongue function is important for masticatory performance in the healthy elderly: a cross-sectional survey of community-dwelling elderly. J Prosthodont Res. 2019 Jan;63(1):31-34. doi: 10.1016/j.jpor.2018.03.006. Epub 2018 Sep 7. — View Citation

Van den Steen L, De Bodt M, Guns C, Elen R, Vanderwegen J, Van Nuffelen G. Tongue-Strengthening Exercises in Healthy Older Adults: Effect of Exercise Frequency - A Randomized Trial. Folia Phoniatr Logop. 2021;73(2):109-116. doi: 10.1159/000505153. Epub 2020 Feb 5. — View Citation

Van den Steen L, Schellen C, Verstraelen K, Beeckman AS, Vanderwegen J, De Bodt M, Van Nuffelen G. Tongue-Strengthening Exercises in Healthy Older Adults: Specificity of Bulb Position and Detraining Effects. Dysphagia. 2018 Jun;33(3):337-344. doi: 10.1007/s00455-017-9858-3. Epub 2017 Oct 19. — View Citation

Van den Steen L, Vanderwegen J, Guns C, Elen R, De Bodt M, Van Nuffelen G. Tongue-Strengthening Exercises in Healthy Older Adults: Does Exercise Load Matter? A Randomized Controlled Trial. Dysphagia. 2019 Jun;34(3):315-324. doi: 10.1007/s00455-018-9940-5. Epub 2018 Sep 12. — View Citation

Yoshimi K, Nakagawa K, Hara K, Yamaguchi K, Nakane A, Kubota K, Furuya J, Tohara H. Relationship between tongue pressure and back muscle strength in healthy elderly individuals. Aging Clin Exp Res. 2020 Dec;32(12):2549-2555. doi: 10.1007/s40520-020-01484-5. Epub 2020 Jan 31. — View Citation

Zhang H, Guo F, Tang M, Dai H, Sheng J, Chen L, Liu S, Wang J, Shi Y, Ye C, Hou G, Wu X, Jin X, Chen K. Association between Skeletal Muscle Strength and Dysphagia among Chinese Community-Dwelling Elderly Adults. J Nutr Health Aging. 2020;24(6):642-649. doi: 10.1007/s12603-020-1379-3. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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