NCT03417609

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 31, 2018

Completed
7 days until next milestone

Study Start

First participant enrolled

February 7, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

April 4, 2019

Status Verified

April 1, 2019

Enrollment Period

11 months

First QC Date

January 25, 2018

Last Update Submit

April 2, 2019

Conditions

Keywords

SarcopeniaTongue strength

Outcome Measures

Primary Outcomes (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.

    6 months

Secondary Outcomes (7)

  • Pre-Albumin concentration

    6 months

  • Albumin concentration

    6 months

  • Mini Mental State Examination (MMSE) score

    6 months

  • Minimal nutritional assessment (MNA-SF) score

    6 months

  • Skeletal Mass Muscle Index

    6 months

  • +2 more secondary outcomes

Study Arms (2)

Sarcopenia

Elderly patients with sarcopenia

Device: Tongue strength measurementProcedure: Blood samplingDiagnostic 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

Control

Elderly patients without sarcopenia

Device: Tongue strength measurementProcedure: Blood samplingDiagnostic 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

Interventions

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.

ControlSarcopenia

Blood sampling

ControlSarcopenia

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.

ControlSarcopenia

The minimal nutritional assessment - short form is a simple, non - invasive and validated scale for the detection of malnutrition in the elderly patient.

ControlSarcopenia

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

ControlSarcopenia

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.

ControlSarcopenia
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.

ControlSarcopenia

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Brugmann

Brussels, Belgium

Location

MeSH Terms

Conditions

Sarcopenia

Interventions

Blood Specimen CollectionAbsorptiometry, PhotonWalking Speed

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesRadiographyDiagnostic ImagingDensitometryPhotometryChemistry Techniques, AnalyticalGaitPhysical ExaminationWalkingLocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Alexandrine de Buck van Overstraeten, MD

    CHU Brugmann

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of clinic

Study Record Dates

First Submitted

January 25, 2018

First Posted

January 31, 2018

Study Start

February 7, 2018

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

April 4, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations