- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05291416
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
Conditions
Intervention / Treatment
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.
Sponsor
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
Additional Relevant MeSH Terms
- Nervous System Diseases
- Immune System Diseases
- Autoimmune Diseases
- Neurologic Manifestations
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Neuromuscular Manifestations
- Pathological Conditions, Anatomical
- Muscular Atrophy
- Atrophy
- Arthritis
- Sarcopenia
- Arthritis, Juvenile
Other Study ID Numbers
- pediatric rheumatology Kassab
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.
Clinical Trials on Sarcopenia
-
Cairo UniversityNot yet recruitingGeriatric SarcopeniaEgypt
-
University Hospital, BonnRecruiting
-
Shanghai Yueyang Integrated Medicine HospitalShanghai University of Traditional Chinese Medicine; DongE E Jiao Coporation... and other collaboratorsNot yet recruiting
-
Assiut UniversityNot yet recruiting
-
TNF Pharmaceuticals, Inc.Not yet recruitingFrailty | Sarcopenia in Elderly | Frailty/Sarcopenia | Frailty in Older Adults
-
University of ExtremaduraCompletedSarcopenia in Elderly | Institutionalized Older Adults | HIITSpain
-
Animuscure Inc.Recruiting
-
West China HospitalNot yet recruitingSarcopenia in Elderly
-
Centre Hospitalier Universitaire DijonCompleted
-
Medway NHS Foundation TrustNot yet recruitingFalls | Sarcopenia in ElderlyUnited Kingdom
Clinical Trials on densitometry/ handgrip dynamometer
-
University of MalayaMinistry of Health, MalaysiaUnknownIron-deficiency | Anemia | Iron Deficiency Anemia | Patient Blood ManagementMalaysia
-
University of Mogi das CruzesCompletedHand Injuries and DisordersBrazil
-
University of BrasiliaCompleted
-
Cairo UniversityCompletedArthroscopic Shoulder Surgery | Arthroscopic Bankart Repair | Hand Grip Strength | Rotator Cuff StrengthEgypt
-
University of Mogi das CruzesCompleted
-
Ulucanlar Eye Training and Research HospitalCompletedAcute Primary Angle-closure GlaucomaTurkey
-
Centre Hospitalier Universitaire, AmiensWithdrawnLymphoma | OsteoporosisFrance
-
Centre Hospitalier Universitaire de NiceCompleted
-
Central Park Medical CollegeShalamar Teaching HospitalCompletedPregnancy Related | Hand GraspPakistan