NCT03740061

Brief Summary

Traditionally, muscle mass - a part of the concept of sarcopenia - is measured by computed tomography (CT) or dual-energy X-ray absorptiometry (DEXA) scan. These devices are not always easily available in clinical practice and cannot be used bedside. An innovation in sarcopenia is the assessment of muscle mass and quality with ultrasound. Because this device is much more available and applicable in all patients, diagnosis of acute sarcopenia would be much easier with ultrasound. Moreover, if other factors that contribute to accelerated decline in muscle mass and function can be determinated, the sensiblisation and early screening for acute sarcopenia in those individuals can hopefully prevent them from declining.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

October 23, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

November 14, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

April 28, 2021

Status Verified

April 1, 2021

Enrollment Period

3.2 years

First QC Date

October 23, 2018

Last Update Submit

April 27, 2021

Conditions

Keywords

UltrasoundAssessmentAcute sarcopeniaHospitalized older people

Outcome Measures

Primary Outcomes (5)

  • Change over 7 days in ultrasonographic measured muscle thickness (in centimeter) in the four bellies of the quadriceps muscle

    Change over 7 days in ultrasonographic measured muscle thickness (in centimeter) in the four bellies of the quadriceps muscle

    7 days

  • Change over 7 days in ultrasonographic measured muscle cross-sectional area (in square centimeter) in the four bellies of the quadriceps muscle

    Change over 7 days in ultrasonographic measured muscle cross-sectional area (in square centimeter) in the four bellies of the quadriceps muscle

    7 days

  • Change over 7 days in ultrasonographic measured muscle pennation angle (in degrees) in the four bellies of the quadriceps muscle

    Change over 7 days in ultrasonographic measured muscle pennation angle (in degrees) in the four bellies of the quadriceps muscle

    7 days

  • Change over 7 days in ultrasonographic measured muscle fascicle length (in centimeter) in the four bellies of the quadriceps muscle

    Change over 7 days in ultrasonographic measured muscle fascicle length (in centimeter) in the four bellies of the quadriceps muscle

    7 days

  • Change over 7 days in ultrasonographic measured muscle echo-intensity (gray values in Houndsfield units) in the four bellies of the quadriceps muscle

    Change over 7 days in ultrasonographic measured muscle echo-intensity (gray values in Houndsfield units) in the four bellies of the quadriceps muscle

    7 days

Secondary Outcomes (10)

  • Influence of muscle thickness on muscle strength measured by hand grip strength

    7 days

  • Influence of muscle cross-sectional area on muscle strength measured by hand grip strength

    7 days

  • Influence of muscle pennation angle on muscle strength measured by hand grip strength

    7 days

  • Influence of muscle fascicle length on muscle strength measured by hand grip strength (kg)

    7 days

  • Influence of muscle echo intensity on muscle strength measured by hand grip strength (kg)

    7 days

  • +5 more secondary outcomes

Study Arms (9)

Antwerp

Diagnostic Test: Ultrasonographic assessment of muscle

Barcelona

Diagnostic Test: Ultrasonographic assessment of muscle

Istanbul

Diagnostic Test: Ultrasonographic assessment of muscle

Oldenburg

Diagnostic Test: Ultrasonographic assessment of muscle

Krakow

Diagnostic Test: Ultrasonographic assessment of muscle

Bialystok

Diagnostic Test: Ultrasonographic assessment of muscle

Rome

Diagnostic Test: Ultrasonographic assessment of muscle

Madrid

Diagnostic Test: Ultrasonographic assessment of muscle

Leuven

Diagnostic Test: Ultrasonographic assessment of muscle

Interventions

Ultrasonographic assessment of quadriceps muscle

AntwerpBarcelonaBialystokIstanbulKrakowLeuvenMadridOldenburgRome

Eligibility Criteria

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

All participants ages 65 years or older and admitted to one of the ward of one of the centers in the given time period.

You may qualify if:

  • All participants ages 65 years AND
  • Admitted to one of the ward of one of the centers in the given time period.

You may not qualify if:

  • Patients on dialysis will be excluded because of possible metabolic features.
  • Individuals with paresis of the lower limbs or hemiparesis due to a stroke will be excluded because of neurological involvement that can influence the results.
  • Hypo-or hyperthyroid patients will be excluded because of the role of thyroid hormones in muscle homeostasis.
  • Pitting oedema of the legs (due to heart failure, anasarca oedema, renal failure or liver cirrhosis) or severely dehydrated patients will be excluded because fluid shifts could influence the ultrasound measurement results.
  • Because of possible previous changes in muscle mass, architecture and function, patients with systemic connective tissue disorders, myositis, calcification and ossification of muscle, systemic atrophies primarily affecting the central nervous system and demyelinating diseases of the central nervous system will be excluded.
  • Patients using chronic oral corticosteroids will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ZNA Middelheim

Antwerp, 2020, Belgium

RECRUITING

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

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

Study Officials

  • Stany Perkisas, MD

    Universiteit Antwerpen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stany Perkisas, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

October 23, 2018

First Posted

November 14, 2018

Study Start

January 1, 2019

Primary Completion

March 1, 2022

Study Completion

April 30, 2022

Last Updated

April 28, 2021

Record last verified: 2021-04

Locations