Interest of a Tongue Strength Measurement in the Screening for Sarcopenia in Hospitalized Elderly Patients

April 2, 2019 updated by: Murielle Surquin

Sarcopenia is a syndrome characterized by a progressive and generalized loss of skeletal muscle mass, strength and function that increases the risk of physical dependence, impaired quality of life and mortality. This is a major public health problem. Indeed, its prevalence has been estimated at 63.8% for elderly patients hospitalized in acute geriatric unit.

Several methods of sarcopenia screening exist at present. The European Working Group on Sarcopenia in Older People (EWGSOP) proposes to carry out three examinations for the diagnosis of sarcopenia: the Dual-Energy X-ray Absorptiometry (DEXA) test and two motor tests (walking speed and hand test). These measurements have already been evaluated and validated. They are reliable, inexpensive and easily achievable in clinical routine.

Recent studies have shown that decreased muscle mass and / or strength could be associated with dysphagia. Indeed, many muscles of the head and neck are simultaneously solicited for swallowing coordination. This suggests that a reduction in the mass or strength of these muscles could impact the swallowing function. The investigator's hypothesize that loss of lingual muscle strength may be associated with sarcopenia. The study will measure the tongue strength using the Iowa Oral Performance Instrument (IOPI) in a geriatric population with or without sarcopenia.

  • Determine the incidence of lingual hypotonia in hospitalized elderly sarcopenia patients.
  • To compare the sensitivity, the specificity of the measurement of the force of the tongue with the usual measures proposed by the EWGSOP in the context of screening for sarcopenia.

Study Overview

Study Type

Observational

Enrollment (Actual)

110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Brussels, Belgium
        • CHU Brugmann

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

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients hospitalized in an acute geriatric unit within the CHU Brugmann.

Description

Inclusion Criteria:

Patients hospitalized in an acute geriatric unit within the CHU Brugmann.

Exclusion Criteria:

None

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Sarcopenia
Elderly patients with sarcopenia
The Iowa Oral Performance Instrument is a validated device for assessing the strength of the tongue. This involves placing the tip of a tube in the mouth and asking the patient to exert pressure on it.
Blood sampling
Also called Folstein test, it is an assessment of the patient cognitive and memory functions. It detects cognitive disorders or dementia. The MMSE is quickly realizable and explores several cognitive functions through 30 questions divided into 7 items.
The minimal nutritional assessment - short form is a simple, non - invasive and validated scale for the detection of malnutrition in the elderly patient.
Dual-energy x-ray absorptiometry (DEXA) is the imaging technique recommended for the diagnosis of sarcopenia.
By placing a dynamometer in the patient's hand and asking him to apply maximum pressure to it, the muscular strength of the extremities of the limbs is estimated.
Walking speed evaluates the muscular performance. The seated patient must get up and walk a distance of 6 meters as quickly as possible without the help of a third party.
Control
Elderly patients without sarcopenia
The Iowa Oral Performance Instrument is a validated device for assessing the strength of the tongue. This involves placing the tip of a tube in the mouth and asking the patient to exert pressure on it.
Blood sampling
Also called Folstein test, it is an assessment of the patient cognitive and memory functions. It detects cognitive disorders or dementia. The MMSE is quickly realizable and explores several cognitive functions through 30 questions divided into 7 items.
The minimal nutritional assessment - short form is a simple, non - invasive and validated scale for the detection of malnutrition in the elderly patient.
Dual-energy x-ray absorptiometry (DEXA) is the imaging technique recommended for the diagnosis of sarcopenia.
By placing a dynamometer in the patient's hand and asking him to apply maximum pressure to it, the muscular strength of the extremities of the limbs is estimated.
Walking speed evaluates the muscular performance. The seated patient must get up and walk a distance of 6 meters as quickly as possible without the help of a third party.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tongue strength
Time Frame: 6 months
The Iowa Oral Performance Instrument is a validated device for assessing the strength of the tongue. This involves placing the tip of a tube in the mouth and asking the patient to exert pressure on it. Thus, a pressure measurement expressed in kPa makes it possible to objectify the tongue strength.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pre-Albumin concentration
Time Frame: 6 months
Albumin and pre-albumin are biological markers for undernutrition. Pre-albumin is an earlier marker than albumin because of its shorter half-life, 48 hours versus 21 days. The normal pre-albumin values are between 200 and 400 mg /L, undernutrition is serious if it is less than 150mg/dL.
6 months
Albumin concentration
Time Frame: 6 months
Albumin and pre-albumin are biological markers for undernutrition. Pre-albumin is an earlier marker than albumin because of its shorter half-life, 48 hours versus 21 days.The normal values of albumin are between 40 and 45g/L, between 30 and 35g/L there is moderate undernutrition and under 30g/L it is severe undernutrition.
6 months
Mini Mental State Examination (MMSE) score
Time Frame: 6 months

Also called Folstein test, it is an assessment of the patient cognitive and memory functions. It detects cognitive disorders or dementia. The MMSE is quickly realizable and explores several cognitive functions through 30 questions divided into 7 items: Orientation ability - Learning and transcription skills - Attention and calculation skills - Memory retention capacity - Language and naming capability - Constructive Praxy.

A MMSE score over 27 indicates normal cognitive functions (maximum: 29). A MMSE score between 24 and 27 indicates mild cognitive impairment. A MMSE score under 24 indicates dementia.

6 months
Minimal nutritional assessment (MNA-SF) score
Time Frame: 6 months

The minimal nutritional assessment - short form is a simple, non - invasive and validated scale for the detection of malnutrition in the elderly patient. It takes into account the patient's loss of appetite, weight loss, motor skills, recent health status, neuropsychological disorders

The maximum score of the MNA-SF is 14:

  • Greater than or equal to 11: normal nutritional status.
  • Between 8 and 11: risk of malnutrition.
  • Less than 8: proven malnutrition.
6 months
Skeletal Mass Muscle Index
Time Frame: 6 months
Dual-energy x-ray absorptiometry (DEXA) is the imaging technique recommended for the diagnosis of sarcopenia. It gives minimal irradiation and gives an adequate estimate of the appendicular muscle mass (ALM). By dividing the ALM by the size in centimeters, we obtain the Skeletal Mass Muscle Index (SMI). SMI values below 2 standard deviations from the mean point towards sarcopenia.
6 months
Hand grip strength
Time Frame: 6 months
By placing a dynamometer in the patient's hand and asking him to apply maximum pressure to it, the muscular strength of the extremities of the limbs is estimated.
6 months
Walking speed
Time Frame: 6 months
Walking speed evaluates the muscular performance. The seated patient must get up and walk a distance of 6 meters as quickly as possible without the help of a third party. It has been shown that there is a non-linear relationship between walking speed and muscle strength.
6 months

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Alexandrine de Buck van Overstraeten, MD, CHU Brugmann

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 (Actual)

February 7, 2018

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

January 25, 2018

First Submitted That Met QC Criteria

January 25, 2018

First Posted (Actual)

January 31, 2018

Study Record Updates

Last Update Posted (Actual)

April 4, 2019

Last Update Submitted That Met QC Criteria

April 2, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

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.

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