Fitness Level in Short Stature Children and After Growth Hormone Treatment

Sponsor
Meir Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT02977091
Collaborator
(none)
50
1
26.5
1.9

Study Details

Study Description

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 Phase
  • 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 Design

Study Type:
Observational
Anticipated 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 :
Dec 15, 2016
Anticipated Primary Completion Date :
Dec 31, 2018
Anticipated Study Completion Date :
Mar 1, 2019

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. change in fitness level [change of fitness levels from base line and after 6 month in short children]

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Meir Medical Center endocrine unit Kfar Saba Israel

Sponsors and Collaborators

  • Meir Medical Center

Investigators

  • Principal Investigator: Nitsan Dror, MD, senior in pediatric medicine

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Dror Nitsan, M.D, Meir Medical Center
ClinicalTrials.gov Identifier:
NCT02977091
Other Study ID Numbers:
  • 0258-16-MMC
First Posted:
Nov 30, 2016
Last Update Posted:
Oct 5, 2018
Last Verified:
Oct 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Dror Nitsan, M.D, Meir Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 5, 2018