Health TrialsbyHealthPanel

Evaluation of Muscle Strength and Muscle Mass in Patients With Inflammatory Bowel Disease

ConditionCrohn Disease (CD)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSakarya University

About this trial

This prospective observational study aims to evaluate the validity of ultrasonographic muscle measurements in patients with inflammatory bowel disease (IBD). Sarcopenia is commonly assessed using computed tomography (CT)-based skeletal muscle area measurements at the L3 vertebral level, which are considered a gold standard method. However, CT is not always feasible due to radiation exposure and accessibility limitations.

In this study, muscle strength will be assessed using handgrip dynamometry, and muscle mass will be evaluated using ultrasonography of selected skeletal muscles. In patients with available recent abdominal CT imaging, L3 skeletal muscle area will be recorded. The primary objective is to compare ultrasonographic muscle measurements with CT-based assessments and to evaluate the agreement between these methods.

This study aims to determine whether ultrasonography can serve as a practical and reliable alternative tool for muscle mass evaluation in patients with IBD.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years

Established diagnosis of inflammatory bowel disease (ICD-10: K50.* Crohn's disease, K51.* ulcerative colitis)

Ability to provide written informed consent

Ability to undergo ultrasonographic muscle assessment and handgrip strength testing

Disqualifiers

Known neuromuscular disorders or primary muscle diseases

Major orthopedic conditions affecting muscle strength assessment

Pregnancy

Abdominal wall defects or conditions interfering with ultrasound assessment

Trial population

Adult patients with inflammatory bowel disease (Crohn's disease or ulcerative colitis) followed at a tertiary care center and undergoing muscle mass and strength evaluation.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Muscle Ultrasonography

    Diagnostic test

    Standardized ultrasonographic measurement of skeletal muscle thickness and quality performed in patients with inflammatory bowel disease for comparison with reference muscle assessment methods.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Inflammatory Bowel Disease Cohort1 intervention

Trial outcomes

Primary outcomes

1

Agreement Between Ultrasound and Reference Muscle Measurement

Agreement and correlation between ultrasound-based muscle measurements and reference (gold-standard) muscle assessment methods in patients with inflammatory bowel disease.

Time frame
Baseline (at time of assessment)

Secondary outcomes

1

Diagnostic Accuracy of Ultrasound for Detecting Low Muscle Mass Defined by CT-L3

Diagnostic performance of ultrasound-measured muscle thickness and quality for identifying low skeletal muscle mass as defined by CT-derived skeletal muscle index (SMI) at the L3 vertebral level. Area under the receiver operating characteristic curve (AUC), sensitivity, specificity, and optimal cutoff values will be calculated.

Time frame
Baseline
2

Association Between Ultrasound Muscle Measurements and Handgrip Strength

Association between ultrasound-measured muscle thickness and muscle quality parameters and handgrip strength measurements in patients with inflammatory bowel disease.

Time frame
Baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sakarya University

Lead sponsor

Source ClinicalTrials.gov
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