NCT01407458

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

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
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2011

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 2, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

August 2, 2011

Status Verified

August 1, 2011

Enrollment Period

1 year

First QC Date

July 26, 2011

Last Update Submit

August 1, 2011

Conditions

Bone StrengthBone Density

Outcome Measures

Primary Outcomes (2)

  • Bone strength

    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.

    One year

  • Bone density

    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.

    One year

Study Arms (2)

Experimental Group

ACTIVE COMPARATOR

Children doing additional exercises with upper limbs in physical education class

Other: Upper Limb Exercises

Control Group

ACTIVE COMPARATOR

Children doing normal physical education exercises

Other: Normal physical exercises

Interventions

Upper Limb ExercisesOTHER

Upper limb exercises

Experimental Group
Normal physical exercisesOTHER

Exercises usually done by children in physical education classes

Control Group

Eligibility Criteria

Age6 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • First and second grade pupils
  • Healthy

You may not qualify if:

  • Medical condition does not permit participation in physical education class

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

July 26, 2011

First Posted

August 2, 2011

Study Start

October 1, 2011

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

August 2, 2011

Record last verified: 2011-08

Locations

IL(1)