NCT06792279

Brief Summary

The goal of this observational study is to evaluate the validity and reliability of ultrasound echo intensity (EI) as a diagnostic tool for assessing muscle quality in children aged 10-14 years, including normal-weight, obese, and trained young athletes. The main questions it aims to answer are: Can EI reliably and accurately measure muscle quality in children when validated against gold-standard techniques like DXA and isokinetic dynamometry? What are the age-, sex-, and fitness-specific benchmarks for EI to differentiate between normal and pathological muscle quality?

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
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 15, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 24, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

January 24, 2025

Status Verified

January 1, 2025

Enrollment Period

1.1 years

First QC Date

January 15, 2025

Last Update Submit

January 20, 2025

Conditions

Ultrasonography

Outcome Measures

Primary Outcomes (1)

  • Echo intensity of the vastus lateralis (VL) and rectus femoris (RF) muscles

    Echo intensity will be measured by greyscale analysis derivered from ultrasound imaging.

    Through study completion, an average of 1 year

Secondary Outcomes (2)

  • Skeletal Muscle Mass

    Through study completion, an average of 1 year

  • Muscle Strength

    Through study completion, an average of 1 year

Eligibility Criteria

Age10 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Sixty boys and sixty girls aged 10-14 years, evenly distributed as follows: normal-weight children, trained young athletes (≥3 training sessions per week), and obese children according to BMI

You may qualify if:

  • Generally healthy children

You may not qualify if:

  • Acute illnesses
  • Chronic or acute diseases of the endocrine or musculoskeletal systems
  • Post-traumatic conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Education and Sport Charles University

Prague, Czech Republic, 16200, Czechia

Location

Related Publications (1)

  • Jandova T, Kinkorova I, Vetrovsky T, Mala J, Musilova E, Steffl M, Narici MV. Can ultrasound echo intensity assess muscle quality in children aged 10-14 years? Protocol for a cross-sectional validation study in Czech children. BMJ Open. 2025 Sep 26;15(9):e100495. doi: 10.1136/bmjopen-2025-100495.

    PMID: 41005786DERIVED

Central Study Contacts

Michal Steffl, PhD

CONTACT

+420778701882michal.steffl@ftvs.cuni.cz

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ass. prof.

Study Record Dates

First Submitted

January 15, 2025

First Posted

January 24, 2025

Study Start

March 1, 2025

Primary Completion

March 31, 2026

Study Completion

March 31, 2026

Last Updated

January 24, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)