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SarcopeniaNCT03417609

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

An observational study of Sarcopenia, run by Murielle Surquin at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Sarcopenia
What is being tested?
Tongue strength measurement, Blood sampling and Mini Mental State Examination (MMSE)
How many people
110 participants
Where
1 siteBelgium
Study dates
7 Feb 2018to 1 Jan 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

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

Who may be able to join

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

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • CHU Brugmann

    Brussels

Other trials in Belgium

About this study

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.

Read more

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.
Conditions
Sarcopenia
Being tested
Tongue strength measurement, Blood sampling, Mini Mental State Examination (MMSE), Minimal nutritional assessment (MNA-SF), Dual-energy x-ray absorptiometry (DEXA)
Keywords
Sarcopenia, Tongue strength
Medical subject headings
Sarcopenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tongue strength measurementDevice

    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 samplingProcedure or surgery

    Blood sampling

  • Mini Mental State Examination (MMSE)Diagnostic test

    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.

  • Minimal nutritional assessment (MNA-SF)Diagnostic test

    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)Diagnostic test

    Dual-energy x-ray absorptiometry (DEXA) is the imaging technique recommended for the diagnosis of sarcopenia.

  • Dynamometer (Hand grip )Device

    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 speedDiagnostic test

    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.

Study groups in NCT03417609
Study groupRoleWhat they receive
SarcopeniaElderly patients with sarcopenia
Receives: Device: Tongue strength measurement; Procedure: Blood sampling; Diagnostic Test: Mini Mental State Examination (MMSE); Diagnostic Test: Minimal nutritional assessment (MNA-SF); Diagnostic Test: Dual-energy x-ray absorptiometry (DEXA); Device: Dynamometer (Hand grip ); Diagnostic Test: Walking speed
ControlElderly patients without sarcopenia
Receives: Device: Tongue strength measurement; Procedure: Blood sampling; Diagnostic Test: Mini Mental State Examination (MMSE); Diagnostic Test: Minimal nutritional assessment (MNA-SF); Diagnostic Test: Dual-energy x-ray absorptiometry (DEXA); Device: Dynamometer (Hand grip ); Diagnostic Test: Walking speed

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tongue strength

    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.

    Measured: 6 months

Secondary outcomes (7)

  1. Pre-Albumin concentration

    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.

    Measured: 6 months

  2. Albumin concentration

    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.

    Measured: 6 months

  3. Mini Mental State Examination (MMSE) score

    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.

    Measured: 6 months

  4. Minimal nutritional assessment (MNA-SF) score

    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.

    Measured: 6 months

  5. Skeletal Mass Muscle Index

    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.

    Measured: 6 months

  6. Hand grip strength

    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.

    Measured: 6 months

  7. Walking speed

    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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2018
  2. Study start7 Feb 2018
  3. Primary completion1 Jan 2019
  4. Study completion1 Jan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03417609
Sponsor's protocol ID
CHUB-sarcopenia-tongue
Status last verified
Apr 2019
First submitted
25 Jan 2018
Last updated
4 Apr 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Sarcopenia, run by Murielle Surquin at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tongue strength (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03417609.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2019.

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