Fitness Level in Short Stature Children and After Growth Hormone Treatment

Fitness Clinical Trial

Official title:

Fitness Level in Short Stature Children and After Growth Hormone Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02977091
• Other study ID #: 0258-16-MMC
• Status: Recruiting
• Start date: December 15, 2016
• Est. completion date: March 1, 2019

Study information

• Verified date: October 2018
• Source: Meir Medical Center
• Contact: Nitsan Dror, MD
• Phone: 00972-9-7471910
• Email: nitzand[@]clalit.org.il
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

fitness and Physical activity will be evaluate in short stature children, using the Euro Fitness testing and the Wingate anaerobic test. the fitness level will be evaluate in healthy short children and with growth hormone deficiency at base line and after 6 month .

Description:

The Euro Fitness testing which is a series of field testing for children evaluating aerobic, strength and flexibility and the Wingate anaerobic test which is a 30 seconds maximum pedaling against resistance on bike for evaluating the anaerobic fitness.

the fitness test will be done in healthy short stature children and in growth hormone deficiency or idiopathic short stature from the endocrine unit in Meir medical center The test will be done at base line and after 6 month . The fitness test in child with growth hormone deficiency will be done before starting GH treatment and 6 month later.

The child will be asked to fill a questioner about his daily physical activity Anthropometric measurement will be taking including weight, height and fat percent. Details about age, sex, tanner stage, indication for growth hormone, dose, insulin growth factor-1 (IGF1) level will be taken from the medical file.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 1, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

Inclusion Criteria:

• short stature

• Physical healthy

• Mental healthy

• Capable to perform fitness test

Exclusion Criteria:

• Cardiac disease that interfere or risk the child during physical activity

• Respiratory disease that interfere or risk the child during physical activity

• Musculoskeletal disease interfering physical preformance.

• Family history of death for unknown reasons at an early age.

• Uncontroled thyroid diseae

Related Conditions & MeSH terms

• Dwarfism
• Fitness

Intervention

Other:
• change in fitness level
fitness level assessed by the Euro-fit tests for school age children.including 1.body fat 2. single leg balance test 3.Plate Tapping -for speed of limb movement 4.Sit-and-Reach flexibility test 5. Standing Broad Jump - measures explosive leg power. 6.Handgrip Test - measures static arm strength 7.Sit-Ups in 30 seconds - measures trunk strength 8.Bent Arm Hang - muscular endurance/functional strength 9.20 m endurance shuttle-run - cardiorespiratory endurance Wingate anaerobic test which is a 30 seconds maximum pedaling against resistance on bike for evaluating the anaerobic fitness

Locations

Country	Name	City	State
Israel	Meir Medical Center endocrine unit	Kfar Saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (3)

Bar-Or O. The Wingate anaerobic test. An update on methodology, reliability and validity. Sports Med. 1987 Nov-Dec;4(6):381-94. Review. — View Citation

Godin G, Shephard RJ. A simple method to assess exercise behavior in the community. Can J Appl Sport Sci. 1985 Sep;10(3):141-6. — View Citation

Ranson R, Stratton G, Taylor SR. Digit ratio (2D:4D) and physical fitness (Eurofit test battery) in school children. Early Hum Dev. 2015 May;91(5):327-31. doi: 10.1016/j.earlhumdev.2015.03.005. Epub 2015 Apr 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in fitness level		change of fitness levels from base line and after 6 month in short children

External Links

•   The Eurofit Physical Fitness Test Battery