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Fitness Level in Short Stature Children and After Growth Hormone Treatment

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ClinicalTrials.gov Identifier: NCT02977091
Recruitment Status : Recruiting
First Posted : November 30, 2016
Last Update Posted : October 5, 2018
Sponsor:
Information provided by (Responsible Party):
Dror Nitsan, Meir Medical Center

Brief 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 .

Condition or disease Intervention/treatment
Fitness 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.


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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Fitness Level in Short Stature Children and After Growth Hormone Treatment
Actual Study Start Date : December 15, 2016
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dwarfism Hormones

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




Primary Outcome Measures :
  1. change in fitness level [ Time Frame: change of fitness levels from base line and after 6 month in short children ]


Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
short stature children
Criteria

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

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): NCT02977091


Contacts
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Contact: Nitsan Dror, MD 00972-9-7471910 nitzand@clalit.org.il
Contact: Michal Pantanowitz, PHD 00972-9-7471596 michalmirochnik@gmail.com

Locations
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Israel
Meir Medical Center endocrine unit Recruiting
Kfar Saba, Israel
Contact: Nitsan Dror, MD    0097297471596    nitzand@clalit.org.il   
Sponsors and Collaborators
Meir Medical Center
Investigators
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Principal Investigator: Nitsan Dror, MD senior in pediatric medicine

Additional Information:
Publications:
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Responsible Party: Dror Nitsan, M.D, Meir Medical Center
ClinicalTrials.gov Identifier: NCT02977091     History of Changes
Other Study ID Numbers: 0258-16-MMC
First Posted: November 30, 2016    Key Record Dates
Last Update Posted: October 5, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Dror Nitsan, Meir Medical Center:
short stature
fitness
children

Additional relevant MeSH terms:
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Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn
Endocrine System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs