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

Primary Purpose

Dysphagia

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
IOPI Therapy
Tongue Depressor Traditional Intervention
Sponsored by
Khoo Teck Puat Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysphagia

Eligibility Criteria

78 Years - 99 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Control Group

    Intervention Group

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    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.
    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.
    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.
    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.
    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.
    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.

    Full Information

    First Posted
    September 18, 2021
    Last Updated
    September 29, 2021
    Sponsor
    Khoo Teck Puat Hospital
    Collaborators
    National Healthcare Group, Singapore
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05074784
    Brief Title
    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

    2. Study Status

    Record Verification Date
    September 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 1, 2021 (Anticipated)
    Primary Completion Date
    October 1, 2022 (Anticipated)
    Study Completion Date
    November 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Khoo Teck Puat Hospital
    Collaborators
    National Healthcare Group, Singapore

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dysphagia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Patients will be randomized into control group or intervention group.
    Masking
    Care ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    84 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control Group
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Intervention Group
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    IOPI Therapy
    Intervention Description
    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 Type
    Device
    Intervention Name(s)
    Tongue Depressor Traditional Intervention
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Percentage of increase in tongue strength
    Description
    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.
    Time Frame
    5 intervention days
    Title
    Improvement in score on Functional Oral Intake Scale (FOIS)
    Description
    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.
    Time Frame
    5 intervention days
    Secondary Outcome Measure Information:
    Title
    Improvement in AusTOMs Swallowing Scale Rating
    Description
    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.
    Time Frame
    5 intervention days
    Title
    Improvement in Modified Barthel Index (MBI) Score
    Description
    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.
    Time Frame
    5 intervention days
    Title
    Improvement in hand grip strength (HGS)
    Description
    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.
    Time Frame
    5 intervention days
    Title
    Improvement in timed sit-to-stand duration
    Description
    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.
    Time Frame
    5 intervention days
    Title
    Improvement in the score of the SARC-F questionnaire
    Description
    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.
    Time Frame
    5 intervention days
    Title
    Improvement in overall functional status.
    Description
    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.
    Time Frame
    5 intervention days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    78 Years
    Maximum Age & Unit of Time
    99 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    24854105
    Citation
    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.
    Results Reference
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    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.
    Results Reference
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    PubMed Identifier
    21300744
    Citation
    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.
    Results Reference
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    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
    Results Reference
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    PubMed Identifier
    31158906
    Citation
    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.
    Results Reference
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    PubMed Identifier
    31577721
    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.
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    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.
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    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.
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    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.
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    Effects of IOPI on Swallowing Function and Functional Status in Geriatric Patients

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