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

September 29, 2021 updated by: Choo Wan Ling, Khoo Teck Puat Hospital
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

84

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

78 years to 99 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Group
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
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
Experimental: Intervention Group
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of increase in tongue strength
Time Frame: 5 intervention days
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)
Time Frame: 5 intervention days
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
Time Frame: 5 intervention days
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
Time Frame: 5 intervention days
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)
Time Frame: 5 intervention days
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
Time Frame: 5 intervention days
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
Time Frame: 5 intervention days
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.
Time Frame: 5 intervention days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Khoo Teck Puat Hospital

Collaborators

National Healthcare Group, Singapore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2021

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

November 1, 2022

Study Registration Dates

First Submitted

September 18, 2021

First Submitted That Met QC Criteria

September 29, 2021

First Posted (Actual)

October 12, 2021

Study Record Updates

Last Update Posted (Actual)

October 12, 2021

Last Update Submitted That Met QC Criteria

September 29, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021/00223

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dysphagia

Clinical Trials on Tongue Depressor Traditional Intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jamaica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe