NCT02977091

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 .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 30, 2016

Completed
15 days until next milestone

Study Start

First participant enrolled

December 15, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

October 5, 2018

Status Verified

October 1, 2018

Enrollment Period

2 years

First QC Date

November 21, 2016

Last Update Submit

October 3, 2018

Conditions

Fitness

Keywords

short staturefitnesschildren

Outcome Measures

Primary Outcomes (1)

  • change in fitness level

    change of fitness levels from base line and after 6 month in short children

Study Arms (2)

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

short stature

healthy short children

Other: change in fitness level

Interventions

change in fitness levelOTHER

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

GH deficiency or idiopathic short statureshort stature

Eligibility Criteria

Age5 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

short stature children

You may qualify if:

  • short stature
  • Physical healthy
  • Mental healthy
  • Capable to perform fitness test

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir Medical Center endocrine unit

Kfar Saba, Israel

RECRUITING

Related 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. doi: 10.2165/00007256-198704060-00001. No abstract available.

    PMID: 3324256BACKGROUND

  • 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.

    PMID: 4053261BACKGROUND

  • 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.

    PMID: 25846842BACKGROUND

Related Links

MeSH Terms

Conditions

Dwarfism

Condition Hierarchy (Ancestors)

Bone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesEndocrine System Diseases

Study Officials

  • Nitsan Dror, MD

    senior in pediatric medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nitsan Dror, MD

CONTACT

00972-9-7471910nitzand@clalit.org.il

Michal Pantanowitz, PHD

CONTACT

00972-9-7471596michalmirochnik@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D

Study Record Dates

First Submitted

November 21, 2016

First Posted

November 30, 2016

Study Start

December 15, 2016

Primary Completion

December 31, 2018

Study Completion

March 1, 2019

Last Updated

October 5, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)