SarcopeniaNCT06001931
Determination of Reference Values for Handgrip Strength and Bioimpedance Values in Healthy Turkish Children
An observational study of Sarcopenia and Child Development, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
In this study, our aim is to determine the reference values for the handgrip force and bioimpedance values in healthy Turkish children. Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Child Development
- What is being tested?
- handgrip force and bioimpedance values in healthy Turkish children.
- How many people
- 800 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 26 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Healthy Turkish children
Who may be able to join
- healthy children
- Children under 18
- Turkish children
Who cannot join
- Children with malignancy or known chronic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reference Values for Handgrip Strength and Bioimpedance Values in Healthy Turkish Children
In this study, our aim is to determine the reference values for the handgrip force and bioimpedance values in healthy Turkish children.
Read the 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.
- Conditions
- Sarcopenia, Child Development
- Being tested
- handgrip force and bioimpedance values in healthy Turkish children.
- Keywords
- children, muscle strength, bioimpedance
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
handgrip force and bioimpedance values in healthy Turkish children.Other
Demographic characteristics, calf circumference , Hand grip strength , TANITA BIA analysis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 interview day
Body Mass Index (BMI)
BMI will be calculated as weight (kg) divided by height2 (m2)
Measured: 1 interview day
Skeletal muscle mass
Skeletal muscle mass will be evaluated using a Tanita DC-360 multi-frequency body composition analysis device.
Measured: 1 interview day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start1 Sep 2023
- Primary completion26 Sep 2023
- Study completion26 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tuğba Aydın, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Investigators
- TUGBA AYDIN, Principal investigator, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06001931
- Sponsor's protocol ID
- IstanbulPMRTRHChldBioimpedans
- Status last verified
- Sep 2023
- First submitted
- 15 Aug 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30499245McCarthy 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.
PubMed 23776133Rauch 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.
PubMed 11919337Molenaar 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.
PubMed 19459024
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reference Values for Handgrip Strength and Bioimpedance Values in Healthy Turkish Children
- ClinicalTrials.gov ID
- NCT06001931
- Acronym / sponsor ID
- IstanbulPMRTRHChldBioimpedans
- Conditions
- Sarcopenia, Child Development
- Keywords
- children, muscle strength, bioimpedance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 26 Sep 2023 (actual)
- Study completion
- 26 Sep 2023 (actual)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, our aim is to determine the reference values for the 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
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Healthy Turkish children
Key inclusion criteria (3 listed)
- healthy children
- Children under 18
- Turkish children
Key exclusion criteria (1 listed)
- Children with malignancy or known chronic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| handgrip force and bioimpedance values in healthy Turkish children.Demographic characteristics, calf circumference , Hand grip strength , TANITA BIA analysis | Other | – |
Primary outcome
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.
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.
Body Mass Index (BMI)
Time frame: 1 interview day
BMI will be calculated as weight (kg) divided by height2 (m2)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Background: PubMed 30499245Liu 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.
- Background: PubMed 23776133McCarthy 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.
- Background: PubMed 11919337Rauch 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.
- Background: PubMed 19459024Molenaar 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
TUGBA AYDIN principal investigator
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia and Child Development, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
handgrip strength (time frame: 1 interview day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06001931, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.