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

NCT05074784 | Unknown

• 1 other identifier: 2021/00223
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dysphagia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Improvement in AusTOMs Swallowing Scale Rating

  5 intervention days

• Improvement in Modified Barthel Index (MBI) Score

  5 intervention days

• Improvement in hand grip strength (HGS)

  5 intervention days

• Improvement in timed sit-to-stand duration

  5 intervention days

• Improvement in the score of the SARC-F questionnaire

  5 intervention days

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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

Intervention Group

EXPERIMENTAL

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

Interventions

IOPI Therapy DEVICE

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.

Intervention Group

Tongue Depressor Traditional Intervention DEVICE

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

Control Group

Eligibility Criteria

• Age: 78 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Khoo Teck Puat Hospital: lead
• National Healthcare Group, Singapore: collaborator

Related 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.

  PMID: 24854105 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 21300744 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 31158906 BACKGROUND

• 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.

  PMID: 31577721 BACKGROUND

• 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.

  PMID: 30197226 BACKGROUND

• 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.

  PMID: 29052051 BACKGROUND

• 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.

  PMID: 30209561 BACKGROUND

• 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.

  PMID: 32023617 BACKGROUND

• 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.

  PMID: 32006384 BACKGROUND

• 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.

  PMID: 32510118 BACKGROUND

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Speech Therapist

Model Details: Patients will be randomized into control group or intervention group.

Study Record Dates

• First Submitted: September 18, 2021
• First Posted: October 12, 2021
• Study Start: October 1, 2021
• Primary Completion: October 1, 2022
• Study Completion: November 1, 2022
• Last Updated: October 12, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share