- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03417609
Interest of a Tongue Strength Measurement in the Screening for Sarcopenia in Hospitalized Elderly Patients
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
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Brussels, Belgium
- CHU Brugmann
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Patients hospitalized in an acute geriatric unit within the CHU Brugmann.
Exclusion Criteria:
None
Study Plan
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:
|
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
Sponsor
Investigators
- Principal Investigator: Alexandrine de Buck van Overstraeten, MD, CHU Brugmann
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUB-sarcopenia-tongue
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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 Sarcopenia
-
University of Texas at AustinNot yet recruitingExercise Training and SarcopeniaUnited States
-
Centre Hospitalier Universitaire DijonCompleted
-
Creighton UniversityUniversity of NebraskaRecruiting
-
University Hospital, CaenCompleted
-
University of NottinghamUniversity of OxfordRecruitingMuscle Atrophy | Age-Related SarcopeniaUnited Kingdom
-
Tufts UniversityNational Institute on Aging (NIA)CompletedMuscle Loss | Age-Related SarcopeniaUnited States
-
China Medical University HospitalCompleted
-
King's College LondonCo-sponsor: Guy's and St Thomas' NHS Foundation TrustCompletedFrailty | Sarcopenia | Age-Related SarcopeniaUnited Kingdom
-
Norwegian School of Sport SciencesOslo University HospitalNot yet recruitingHealthy Aging | Testosterone Deficiency | Age-Related Sarcopenia
-
Ningbo Medical Center Lihuili HospitalCompletedHemodialysis Patients With SarcopeniaChina
Clinical Trials on Tongue strength measurement
-
University Health Network, TorontoUniversity of Florida; National Institute on Deafness and Other Communication...CompletedParkinson Disease | Amyotrophic Lateral Sclerosis | DysphagiaUnited States
-
Centre d'Investigation Clinique et Technologique...Unknown
-
University of FloridaCompletedSleep Apnea, Obstructive | SnoringUnited States
-
Toronto Rehabilitation InstituteCompleted
-
Université Catholique de LouvainRecruiting
-
Kars State HospitalCompletedMuscle Weakness | Myofascial Pain SyndromeTurkey
-
Cambridge University Hospitals NHS Foundation TrustUnknownFemoroacetabular Impingement
-
University of SouthamptonUniversity Hospital Southampton NHS Foundation TrustUnknownInflammatory Bowel Disease | Nutrition
-
Kindai UniversityCompletedChronic Obstructive Pulmonary DiseaseJapan
-
King Khalid UniversityCompletedYoung AdultSaudi Arabia