Sarcopenia in Children

March 12, 2022 updated by: lassoued ferjani Hanene, University Tunis El Manar

Sarcopenia; a New Issue in Juvenile Idiopathic Arthritis

Juvenile idiopathic arthritis (AJI), is a frequent inflammatory disease in children, characterized by pain, arthritis, and deformities. Chronic inflammation leads to physical inactivity and can be associated with muscle weakness around affected joints, low bone strength, and mass(3). To our knowledge, no study has focused on the prevalence of sarcopenia in JIA and the data on the muscle disorder are lacking. The purpose of the present study is to detect sarcopenia and identify associated factors in children with JIA

Study Overview

Status

Not yet recruiting

Study Type

Observational

Enrollment (Anticipated)

60

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 16 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

For all patients, we collected the anthropometric data including weight, height, and expressed it as Z scores for age and sex. Body mass index (BMI) was calculated as weight (kg)/height (m2). The disease duration, AJI subtype, disease activity, and treatment were recorded.

Description

Inclusion Criteria:

  • children with juvenile idiopathic arthritis fulfilling the ILAR criteria

Exclusion Criteria:

  • We excluded patients who have a prosthesis, nutritional problems, inflammatory bowel disease, coeliac disease, temporomandibular involvement, or another chronic disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
healthy children aged between 4-16 years
all patients will undergo the Dual-energy X-ray absorptiometry (DXA) and the muscle strength assessment using the handgrip dynamometer
2
children aged between 4-16 years, suffering from juvenile idiopathic arthritis
all patients will undergo the Dual-energy X-ray absorptiometry (DXA) and the muscle strength assessment using the handgrip dynamometer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
skeletal muscle mass
Time Frame: 4 months
Dual-energy X-ray absorptiometry (DXA) measures the appendicular lean mass ( the sum of the lean mass of the arms and legs) and adjusted to the body mass index
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
muscle strenght
Time Frame: 5 months
Three consecutive trials will be measured by the handgrip dynamometer between the dominant and non-dominant sides. the highest value will be used and adjusted to the body mass index
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2022

Primary Completion (Anticipated)

October 30, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

March 12, 2022

First Submitted That Met QC Criteria

March 12, 2022

First Posted (Actual)

March 22, 2022

Study Record Updates

Last Update Posted (Actual)

March 22, 2022

Last Update Submitted That Met QC Criteria

March 12, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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