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The Impact of a Structured Physical Activity Program on Bone Strength and Psycho-Motor Learning of Young Children

This study is not yet open for participant recruitment.
Verified August 2011 by Hillel Yaffe Medical Center
Sponsor:
Information provided by:
Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:
NCT01407458
First received: July 26, 2011
Last updated: August 1, 2011
Last verified: August 2011
History of Changes
  Purpose

To examine the impact of a structured physical activity program focused on bone strength in elementary school children in the framework of their physical education classes on:

  1. Bone strength of children participating in the activity.
  2. Physical variables and psycho-motor capabilities: vertical jumping strength, horizontal jumping strength, static balance, dynamic balance and coordination.

Condition Intervention
Bone Strength
Bone Density
 Other: Upper Limb Exercises
Other: Normal physical exercises

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hillel Yaffe Medical Center:

Primary Outcome Measures:
  • Bone strength [ Time Frame: One year ] [ Designated as safety issue: No ]
    Examination of bone strength will be carried out by using a measuring device called Sunlight Omnisense. This device uses SOS (Speed of Sound) to check bone strength and density.

  • Bone density [ Time Frame: One year ] [ Designated as safety issue: No ]
    Examination of bone density will be carried out by using a measuring device called Sunlight Omnisense. This device uses SOS (Speed of Sound) to check bone strength and density.


Estimated Enrollment: 300
Study Start Date: October 2011
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Experimental Group
Children doing additional exercises with upper limbs in physical education class
 Other: Upper Limb Exercises
Upper limb exercises
Active Comparator: Control Group
Children doing normal physical education exercises
 Other: Normal physical exercises
Exercises usually done by children in physical education classes

  Eligibility

Ages Eligible for Study:   6 Years to 9 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • First and second grade pupils
  • Healthy

Exclusion Criteria:

  • Medical condition does not permit participation in physical education class
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01407458

Locations
Israel
Hillel Yaffe Medical Center Not yet recruiting
Hadera, Israel, 38100
Contact: Eias Kassem, MD     972-4-630-4331     eiask@hy.health.gov.il    
Principal Investigator: Eias Kassem, MD            
Sponsors and Collaborators
Hillel Yaffe Medical Center
  More Information

No publications provided

Responsible Party: Eias Kassem, Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT01407458     History of Changes
Other Study ID Numbers: 0043-11-HYMC
Study First Received: July 26, 2011
Last Updated: August 1, 2011
Health Authority: Israel: Ministry of Health

ClinicalTrials.gov processed this record on June 17, 2013