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

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ClinicalTrials.gov Identifier: NCT01407458
Recruitment Status : Unknown
Verified August 2011 by Hillel Yaffe Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : August 2, 2011
Last Update Posted : August 2, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:

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 or disease Intervention/treatment
Bone Strength Bone Density Other: Upper Limb Exercises Other: Normal physical exercises

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : October 2011
Estimated Primary Completion Date : October 2012
Estimated Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Bone strength [ Time Frame: One year ]
    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.

  2. Bone density [ Time Frame: One year ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
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

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): 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

Responsible Party: Eias Kassem, Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT01407458     History of Changes
Other Study ID Numbers: 0043-11-HYMC
First Posted: August 2, 2011    Key Record Dates
Last Update Posted: August 2, 2011
Last Verified: August 2011