Bone StrengthNCT01407458
The Impact of a Structured Physical Activity Program on Bone Strength and Psycho-Motor Learning of Young Children
A study testing Upper Limb Exercises and Normal physical exercises in people with Bone Strength and Bone Density, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Strength, Bone Density
- What is being tested?
- Upper Limb Exercises and Normal physical exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2011to Oct 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- First and second grade pupils
- Healthy
Who cannot join
- Medical condition does not permit participation in physical education class
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hillel Yaffe Medical Center
Hadera, 38100
Eias Kassem, MD, 972-4-630-4331, eiask@hy.health.gov.il
Eias Kassem, MD
About this study
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:
- Bone strength of children participating in the activity.
- Physical variables and psycho-motor capabilities: vertical jumping strength, horizontal jumping strength, static balance, dynamic balance and coordination.
- Conditions
- Bone Strength, Bone Density
- Being tested
- Upper Limb Exercises, Normal physical exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper Limb ExercisesOther
Upper limb exercises
Normal physical exercisesOther
Exercises usually done by children in physical education classes
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Active comparator | Children doing additional exercises with upper limbs in physical education class Receives: Other: Upper Limb Exercises |
| Control Group | Active comparator | Children doing normal physical education exercises Receives: Other: Normal physical exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2011 (estimated)
- Study startOct 2011
- Primary completionOct 2012 (estimated)
- Study completionOct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone StrengthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01407458
- Sponsor's protocol ID
- 0043-11-HYMC
- Status last verified
- Aug 2011
- First submitted
- 26 Jul 2011
- Last updated
- 2 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Structured Physical Activity Program on Bone Strength and Psycho-Motor Learning of Young Children
- ClinicalTrials.gov ID
- NCT01407458
- Acronym / sponsor ID
- 0043-11-HYMC
- Conditions
- Bone Strength, Bone Density
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Oct 2011
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 2 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Bone strength of children participating in the activity.
- Physical variables and psycho-motor capabilities: vertical jumping strength, horizontal jumping strength, static balance, dynamic balance and coordination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Active comparator | Other: Upper Limb ExercisesChildren doing additional exercises with upper limbs in physical education class |
| Control Group | Active comparator | Other: Normal physical exercisesChildren doing normal physical education exercises |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- First and second grade pupils
- Healthy
Key exclusion criteria (1 listed)
- Medical condition does not permit participation in physical education class
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Upper Limb ExercisesUpper limb exercises | Other | Experimental Group |
| Normal physical exercisesExercises usually done by children in physical education classes | Other | Control Group |
Primary outcome
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Upper Limb Exercises and Normal physical exercises in people with Bone Strength and Bone Density, run by Hillel Yaffe Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone strength (time frame: One year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2011.