Fitness Level in Short Stature Children and After Growth Hormone Treatment

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 .

Study Overview

• Status: Unknown
• Conditions: Fitness
• Intervention / Treatment: Other: change in fitness level

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• Israel
  • Kfar Saba, Israel
    • Recruiting
    • Meir Medical Center endocrine unit
    • Contact: Nitsan Dror, MD; Phone Number: 0097297471596; Email: nitzand@clalit.org.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

short stature children

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
GH deficiency or idiopathic short stature; growth hormone (GH) deficiency or idiopathic short stature children before they start GH treatment	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
short stature; healthy short children	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
change in fitness level	change of fitness levels from base line and after 6 month in short children

Collaborators and Investigators

• Sponsor: Meir Medical Center
• Investigators: Principal Investigator: Nitsan Dror, MD, senior in pediatric medicine

Publications and helpful links

General Publications

• 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.
• Bar-Or O. The Wingate anaerobic test. An update on methodology, reliability and validity. Sports Med. 1987 Nov-Dec;4(6):381-94. doi: 10.2165/00007256-198704060-00001. No abstract available.
• 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.

Helpful Links

• The Eurofit Physical Fitness Test Battery

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2016
• Primary Completion (Anticipated): December 31, 2018
• Study Completion (Anticipated): March 1, 2019

Study Registration Dates

• First Submitted: November 21, 2016
• First Submitted That Met QC Criteria: November 27, 2016
• First Posted (Estimate): November 30, 2016

Study Record Updates

• Last Update Posted (Actual): October 5, 2018
• Last Update Submitted That Met QC Criteria: October 3, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: children; fitness; short stature
• Additional Relevant MeSH Terms: Endocrine System Diseases; Genetic Diseases, Inborn; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Developmental; Dwarfism
• Other Study ID Numbers: 0258-16-MMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No