Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 63 of 10364 for:    strength

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03417609
Recruitment Status : Completed
First Posted : January 31, 2018
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Murielle Surquin, Brugmann University Hospital

Brief 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. 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.

Condition or disease Intervention/treatment
Sarcopenia 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

Layout table for study information
Study Type : Observational
Actual Enrollment : 110 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Interest of a Tongue Strength Measurement in the Screening for Sarcopenia in Hospitalized Elderly Patients
Actual Study Start Date : February 7, 2018
Actual Primary Completion Date : January 1, 2019
Actual Study Completion Date : January 1, 2019

Group/Cohort Intervention/treatment
Sarcopenia
Elderly patients with sarcopenia
Device: Tongue strength measurement
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.

Procedure: Blood sampling
Blood sampling

Diagnostic Test: Mini Mental State Examination (MMSE)
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.

Diagnostic Test: Minimal nutritional assessment (MNA-SF)
The minimal nutritional assessment - short form is a simple, non - invasive and validated scale for the detection of malnutrition in the elderly patient.

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

Device: Dynamometer (Hand grip )
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.

Diagnostic Test: 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.

Control
Elderly patients without sarcopenia
Device: Tongue strength measurement
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.

Procedure: Blood sampling
Blood sampling

Diagnostic Test: Mini Mental State Examination (MMSE)
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.

Diagnostic Test: Minimal nutritional assessment (MNA-SF)
The minimal nutritional assessment - short form is a simple, non - invasive and validated scale for the detection of malnutrition in the elderly patient.

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

Device: Dynamometer (Hand grip )
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.

Diagnostic Test: 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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


  4. 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.

  5. 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. 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.

  7. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients hospitalized in an acute geriatric unit within the CHU Brugmann.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

None


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03417609


Locations
Layout table for location information
Belgium
CHU Brugmann
Brussels, Belgium
Sponsors and Collaborators
Murielle Surquin
Investigators
Layout table for investigator information
Principal Investigator: Alexandrine de Buck van Overstraeten, MD CHU Brugmann

Layout table for additonal information
Responsible Party: Murielle Surquin, Head of clinic, Brugmann University Hospital
ClinicalTrials.gov Identifier: NCT03417609     History of Changes
Other Study ID Numbers: CHUB-sarcopenia-tongue
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Murielle Surquin, Brugmann University Hospital:
Sarcopenia
Tongue strength
Additional relevant MeSH terms:
Layout table for MeSH terms
Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms