Muscle Mass Via UltraSound in Cirrhosis (MMUSCLE)

Condition(s) studied

Investigational drug(s) / intervention(s)

ultrasound: Ultrasound of m. quadriceps and m. thenar All ultrasound measurements will be performed in triplicate, with the average of the scores used in final analyses. Four parameters will be evaluated: muscle thickness, muscle cross sectional area, pennation angle and echo intensity (gain, depth and frequency will be kept constant). Hand grip strength measurement: measurement by an electronic hand dynamometer DynEx1TM (MD Systems, Inc. Ohio, USA). The recommendations for the handgrip strength test of the American Society of Hand Therapists will be followed: The maximum of the three values will be considered for analysis.

Study summary

The goal of this observational cohort study is to learn about loss of muscle mass and muscle strength (sarcopenia) in patients with cirrhosis. The main question\[s\] it aims to answer are:

* what is the prevalence and development of sarcopenia in cirrhosis?
* what is the role of malnutrition? Participants will

* undergo a muscle ultrasound of the lower and upper limb muscles
* handgrip strength will be measured
* malnutrition screening and assessment
* complete a questionnaire to assess quality of life

Eligibility

Primary outcome measure(s)

• Prevalence of sarcopenia: muscle mass — baseline
  Number of patients with prevalent sarcopenia. This will be assessed by skeletal muscle ultrasound (muscle thickness expressed in cm). Sarcopenia has been defined by the European Working Group on Sarcopenia as "a progressive and generalized skeletal muscle disorder associated with an increased likelihood of adverse outcomes including falls, fractures, disability, and mortality," combining both muscle mass and muscle strength or muscle performance in its definition. This first outcome measure defines muscle mass.
• Prevalence of sarcopenia: muscle strength — baseline
  Number of patients with prevalent sarcopenia. This will be assessed by handgrip strength (expressed in kg). Sarcopenia has been defined by the European Working Group on Sarcopenia as "a progressive and generalized skeletal muscle disorder associated with an increased likelihood of adverse outcomes including falls, fractures, disability, and mortality," combining both muscle mass and muscle strength or muscle performance in its definition. As the definition contains both muscle mass and muscle strength, both factors have to be evaluated. This second outcome measure defines muscle strength.
• Development of sarcopenia: changes in muscle mass — 2 years
  Changes in muscle mass by ultrasound muscle parameters from baseline up to 2 years follow-up. We will evaluate the muscle parameters that define muscle mass: muscle thickness expressed in cm, cross sectional area in squared cm, pennation angle in degrees and echo intensity expressed in arbitrary units (A.U.)
• Development of sarcopenia: changes in muscle strength — 2 years
  This will be assessed by handgrip strength (expressed in kg). Sarcopenia has been defined by the European Working Group on Sarcopenia as "a progressive and generalized skeletal muscle disorder associated with an increased likelihood of adverse outcomes including falls, fractures, disability, and mortality," combining both muscle mass and muscle strength or muscle performance in its definition. As the definition contains both muscle mass and muscle strength, both factors have to be evaluated.
• Development of sarcopenia: changes in muscle quality — 2 years
  Changes in muscle mass by ultrasound muscle parameters from baseline up to 2 years follow-up. We will evaluate the muscle parameters that define quality of muscle: pennation angle in degrees and echo intensity expressed in arbitrary units (A.U.)

Trial sites (1)

More University Hospital, Antwerp trials in Belgium

Other trials for the same condition