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Muscle Assessment Through Ultrasound in the Evaluation of Acute Sarcopenia

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ClinicalTrials.gov Identifier: NCT03740061
Recruitment Status : Recruiting
First Posted : November 14, 2018
Last Update Posted : May 14, 2019
Sponsor:
Collaborators:
Hospital Universitario Ramon y Cajal
Universitaire Ziekenhuizen Leuven
Medical University of Bialystok
Catholic University of the Sacred Heart
Universitat Autonoma de Barcelona
Jagiellonian University
Universitat Pompeu Fabra
Istanbul University
University of Oldenburg
Information provided by (Responsible Party):
Stany Perkisas, Universiteit Antwerpen

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.

Condition or disease Intervention/treatment
Sarcopenia Diagnostic Test: Ultrasonographic assessment of muscle

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Evaluation of Acute Sarcopenia in Hospitalized Elderly: Muscle Characteristics Assessment Through Ultrasound
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : November 30, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Antwerp Diagnostic Test: Ultrasonographic assessment of muscle
Ultrasonographic assessment of quadriceps muscle

Barcelona Diagnostic Test: Ultrasonographic assessment of muscle
Ultrasonographic assessment of quadriceps muscle

Istanbul Diagnostic Test: Ultrasonographic assessment of muscle
Ultrasonographic assessment of quadriceps muscle

Oldenburg Diagnostic Test: Ultrasonographic assessment of muscle
Ultrasonographic assessment of quadriceps muscle

Krakow Diagnostic Test: Ultrasonographic assessment of muscle
Ultrasonographic assessment of quadriceps muscle

Bialystok Diagnostic Test: Ultrasonographic assessment of muscle
Ultrasonographic assessment of quadriceps muscle

Rome Diagnostic Test: Ultrasonographic assessment of muscle
Ultrasonographic assessment of quadriceps muscle

Madrid Diagnostic Test: Ultrasonographic assessment of muscle
Ultrasonographic assessment of quadriceps muscle

Leuven Diagnostic Test: Ultrasonographic assessment of muscle
Ultrasonographic assessment of quadriceps muscle




Primary Outcome Measures :
  1. Change over 7 days in ultrasonographic measured muscle thickness (in centimeter) in the four bellies of the quadriceps muscle [ Time Frame: 7 days ]
    Change over 7 days in ultrasonographic measured muscle thickness (in centimeter) in the four bellies of the quadriceps muscle

  2. Change over 7 days in ultrasonographic measured muscle cross-sectional area (in square centimeter) in the four bellies of the quadriceps muscle [ Time Frame: 7 days ]
    Change over 7 days in ultrasonographic measured muscle cross-sectional area (in square centimeter) in the four bellies of the quadriceps muscle

  3. Change over 7 days in ultrasonographic measured muscle pennation angle (in degrees) in the four bellies of the quadriceps muscle [ Time Frame: 7 days ]
    Change over 7 days in ultrasonographic measured muscle pennation angle (in degrees) in the four bellies of the quadriceps muscle

  4. Change over 7 days in ultrasonographic measured muscle fascicle length (in centimeter) in the four bellies of the quadriceps muscle [ Time Frame: 7 days ]
    Change over 7 days in ultrasonographic measured muscle fascicle length (in centimeter) in the four bellies of the quadriceps muscle

  5. Change over 7 days in ultrasonographic measured muscle echo-intensity (gray values in Houndsfield units) in the four bellies of the quadriceps muscle [ Time Frame: 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


Secondary Outcome Measures :
  1. Influence of muscle thickness on muscle strength measured by hand grip strength [ Time Frame: 7 days ]
    Determining what the influence of (changes in) muscle thickness (in centimeter) in the four bellies of the quadriceps muscle is on muscle strength measured by hand grip strength (kg)

  2. Influence of muscle cross-sectional area on muscle strength measured by hand grip strength [ Time Frame: 7 days ]
    Determining what the influence of (changes in) muscle cross-sectional area (in square centimeter) in the four bellies of the quadriceps muscle on muscle strength measured by hand grip strength (kg)

  3. Influence of muscle pennation angle on muscle strength measured by hand grip strength [ Time Frame: 7 days ]
    Determining what the influence of (changes in) muscle pennation angle (in degrees) in the four bellies of the quadriceps muscle is on muscle strength measured by hand grip strength (kg)

  4. Influence of muscle fascicle length on muscle strength measured by hand grip strength (kg) [ Time Frame: 7 days ]
    Determining what the influence of (changes in) muscle fascicle length (in centimeter) in the four bellies of the quadriceps muscle is on muscle strength measured by hand grip strength (kg)

  5. Influence of muscle echo intensity on muscle strength measured by hand grip strength (kg) [ Time Frame: 7 days ]
    Determining what the influence of (changes in) muscle echo intensity (gray values in Houndsfield units) in the four bellies of the quadriceps muscle is on muscle strength measured by hand grip strength (kg)

  6. Influence of muscle thickness on muscle function measured by short physical performance battery [ Time Frame: 7 days ]
    Determining what the relation is between (changes in) muscle thickness (in centimeter) in the four bellies of the quadriceps muscle and muscle function measured by short physical performance battery

  7. Influence of muscle cross-sectional area on muscle function measured by short physical performance battery [ Time Frame: 7 days ]
    Determining what the influence of (changes in) muscle cross-sectional area (in square centimeter) in the four bellies of the quadriceps muscle on muscle function measured by short physical performance battery

  8. Influence of muscle pennation angle on muscle function measured by short physical performance battery [ Time Frame: 7 days ]
    Determining what the influence of (changes in) muscle pennation angle (in degrees) in the four bellies of the quadriceps muscle is on muscle function measured by short physical performance battery

  9. Influence of muscle fascicle length on muscle function measured by short physical performance battery [ Time Frame: 7 days ]
    Determining what the influence of (changes in) muscle fascicle length (in centimeter) in the four bellies of the quadriceps muscle is on muscle function measured by short physical performance battery

  10. Influence of muscle echo intensity on muscle function measured by short physical performance battery [ Time Frame: 7 days ]
    Determining what the influence of (changes in) muscle echo intensity (gray values in Houndsfield units) in the four bellies of the quadriceps muscle is on muscle function measured by short physical performance battery



Information from the National Library of Medicine

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

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

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): NCT03740061


Contacts
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Contact: Stany Perkisas, MD 003232803539 ext 0032 stany.perkisas@zna.be

Locations
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Belgium
ZNA Middelheim Recruiting
Antwerpen, Belgium, 2020
Contact: Stany Perkisas, MD    032803539 ext 0032    stany.perkisas@zna.be   
Sponsors and Collaborators
Universiteit Antwerpen
Hospital Universitario Ramon y Cajal
Universitaire Ziekenhuizen Leuven
Medical University of Bialystok
Catholic University of the Sacred Heart
Universitat Autonoma de Barcelona
Jagiellonian University
Universitat Pompeu Fabra
Istanbul University
University of Oldenburg
Investigators
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Principal Investigator: Stany Perkisas, MD Universiteit Antwerpen
  Study Documents (Full-Text)

Documents provided by Stany Perkisas, Universiteit Antwerpen:

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Responsible Party: Stany Perkisas, Principal investigator, Universiteit Antwerpen
ClinicalTrials.gov Identifier: NCT03740061     History of Changes
Other Study ID Numbers: SARCUS2
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Stany Perkisas, Universiteit Antwerpen:
Ultrasound
Assessment
Acute sarcopenia
Hospitalized older people

Additional relevant MeSH terms:
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Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms