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Determination of Reference Values for Handgrip Strength and Bioimpedance Values in Healthy Turkish Children

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ClinicalTrials.gov Identifier: NCT06001931
Recruitment Status : Completed
First Posted : August 21, 2023
Last Update Posted : September 28, 2023
Sponsor:
Information provided by (Responsible Party):
Tuğba Aydın, Istanbul Physical Medicine Rehabilitation Training and Research Hospital

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

Condition or disease Intervention/treatment
Sarcopenia Child Development Other: handgrip force and bioimpedance values in healthy Turkish children.

Detailed Description:

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

The study was planned as a cross-sectional clinical study. All healthy children studying at Hamdi Akverdi Primary School and Halil Bedii Management Secondary School in the Bakırköy region of Istanbul will be included. The date of birth of the children will be learned. It will be determined in which city in Turkey the population is registered.

TANITA BIA analysis and hand grip strength (with jamar) measured in the dominant hand were planned for all children. In addition, the calf circumference of all children will be measured. Written consent forms will be obtained from the families of the children before the evaluation.

It was planned to include 1500 children in the study.

Study Design
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Study Type : Observational
Actual Enrollment : 800 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Reference Values for Handgrip Strength and Bioimpedance Values in Healthy Turkish Children
Actual Study Start Date : September 1, 2023
Actual Primary Completion Date : September 26, 2023
Actual Study Completion Date : September 26, 2023
Groups and Cohorts
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Intervention Details:
  • Other: handgrip force and bioimpedance values in healthy Turkish children.
    Demographic characteristics, calf circumference , Hand grip strength , TANITA BIA analysis

Outcome Measures
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Primary Outcome Measures :
  1. handgrip strength [ Time Frame: 1 interview day ]
    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.

  2. calf circumference [ Time Frame: 1 interview day ]
    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.

  3. Body Mass Index (BMI) [ Time Frame: 1 interview day ]
    BMI will be calculated as weight (kg) divided by height2 (m2)

  4. Skeletal muscle mass [ Time Frame: 1 interview day ]
    Skeletal muscle mass will be evaluated using a Tanita DC-360 multi-frequency body composition analysis device.


Eligibility Criteria
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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy Turkish children
Criteria

Inclusion Criteria:

  • healthy children
  • Children under 18
  • Turkish children

Exclusion Criteria:

  • Children with malignancy or known chronic disease
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06001931


Locations
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Turkey
Tugba Aydin
İstanbul, Turkey, 34192
Sponsors and Collaborators
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Investigators
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Principal Investigator: TUGBA AYDIN Istanbul Physical Medicine Rehabilitation Training and Research Hospital
More Information
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Publications:

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Responsible Party: Tuğba Aydın, Principal Investigator, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
ClinicalTrials.gov Identifier: NCT06001931    
Other Study ID Numbers: IstanbulPMRTRHChldBioimpedans
First Posted: August 21, 2023    Key Record Dates
Last Update Posted: September 28, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tuğba Aydın, Istanbul Physical Medicine Rehabilitation Training and Research Hospital:
children
muscle strength
bioimpedance
Additional relevant MeSH terms:
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Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
 Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical