NCT06001931

Brief Summary

In this study, our aim is to determine the reference values for the handgrip force and bioimpedance values in healthy Turkish children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

August 15, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 21, 2023

Completed
11 days until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 26, 2023

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

25 days

First QC Date

August 15, 2023

Last Update Submit

September 27, 2023

Conditions

Keywords

childrenmuscle strengthbioimpedance

Outcome Measures

Primary Outcomes (4)

  • handgrip strength

    Handgrip strength will be measured using a Jamar hand grip dynamometer (Model 5030J1, Sammons Preston Rolyan, Bolingbrook, Illinois, USA). Measurements will be taken 3 times in a sitting position with the elbow flexed to 90° and the wrist in neutral position. The measured maximal grip strength will be recorded as hand grip strength.

    1 interview day

  • calf circumference

    Calf circumference is an anthropometric measurement that indicates fatfree muscle mass and has been considered by the World Health Organization (WHO) the most sensitive index for evaluating the decrease in muscle mass. Calf circumference will be measured with an elastic band over the subject's right leg, both sitting and standing.

    1 interview day

  • Body Mass Index (BMI)

    BMI will be calculated as weight (kg) divided by height2 (m2)

    1 interview day

  • Skeletal muscle mass

    Skeletal muscle mass will be evaluated using a Tanita DC-360 multi-frequency body composition analysis device.

    1 interview day

Interventions

Demographic characteristics, calf circumference , Hand grip strength , TANITA BIA analysis

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy Turkish children

You may qualify if:

  • healthy children
  • Children under 18
  • Turkish children

You may not qualify if:

  • Children with malignancy or known chronic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tugba Aydin

Istanbul, 34192, Turkey (Türkiye)

Location

Related Publications (4)

  • Liu J, Yan Y, Xi B, Huang G, Mi J; China Child and Adolescent Cardiovascular Health (CCACH) Study Group. Skeletal muscle reference for Chinese children and adolescents. J Cachexia Sarcopenia Muscle. 2019 Feb;10(1):155-164. doi: 10.1002/jcsm.12361. Epub 2018 Nov 30.

    PMID: 30499245BACKGROUND
  • McCarthy HD, Samani-Radia D, Jebb SA, Prentice AM. Skeletal muscle mass reference curves for children and adolescents. Pediatr Obes. 2014 Aug;9(4):249-59. doi: 10.1111/j.2047-6310.2013.00168.x. Epub 2013 Jun 18.

    PMID: 23776133BACKGROUND
  • Rauch F, Neu CM, Wassmer G, Beck B, Rieger-Wettengl G, Rietschel E, Manz F, Schoenau E. Muscle analysis by measurement of maximal isometric grip force: new reference data and clinical applications in pediatrics. Pediatr Res. 2002 Apr;51(4):505-10. doi: 10.1203/00006450-200204000-00017.

    PMID: 11919337BACKGROUND
  • Molenaar HM, Selles RW, Zuidam JM, Willemsen SP, Stam HJ, Hovius SE. Growth diagrams for grip strength in children. Clin Orthop Relat Res. 2010 Jan;468(1):217-23. doi: 10.1007/s11999-009-0881-z. Epub 2009 May 21.

    PMID: 19459024BACKGROUND

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

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

Study Officials

  • TUGBA AYDIN

    Istanbul Physical Medicine Rehabilitation Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 15, 2023

First Posted

August 21, 2023

Study Start

September 1, 2023

Primary Completion

September 26, 2023

Study Completion

September 26, 2023

Last Updated

September 28, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations