FitnessNCT02977091
Fitness Level in Short Stature Children and After Growth Hormone Treatment
An observational study of Fitness, run by Meir Medical Center at 1 site in Israel.
Trial 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 . Read more about this study
- Who is it for?
- Ages 5 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Fitness
- What is being tested?
- change in fitness level
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- 15 Dec 2016to 1 Mar 2019
- Phase
- Observational
- 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 5 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: short stature children
Who may be able to join
- short stature
- Physical healthy
- Mental healthy
- Capable to perform fitness test
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Meir Medical Center endocrine unit
Kfar Saba
Nitsan Dror, MD, 0097297471596, nitzand@clalit.org.il
About this study
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 .
Read the 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.
- Conditions
- Fitness
- Being tested
- change in fitness level
- Keywords
- short stature, fitness, children
- Medical subject headings
- Dwarfism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
change in fitness levelOther
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
| Study group | Role | What they receive |
|---|---|---|
| GH deficiency or idiopathic short stature | growth hormone (GH) deficiency or idiopathic short stature children before they start GH treatment Receives: Other: change in fitness level | |
| short stature | healthy short children Receives: Other: change in fitness level |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in fitness level
Measured: change of fitness levels from base line and after 6 month in short children
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2016 (estimated)
- Study start15 Dec 2016
- Primary completion31 Dec 2018 (estimated)
- Study completion1 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for FitnessStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dror Nitsan, Meir Medical Center
- Investigators
- Nitsan Dror, MD, Principal investigator, senior in pediatric medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02977091
- Sponsor's protocol ID
- 0258-16-MMC
- Status last verified
- Oct 2018
- First submitted
- 21 Nov 2016
- Last updated
- 5 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Bar-Or O. The Wingate anaerobic test. An update on methodology, reliability and validity. Sports Med. 1987 Nov-Dec;4(6):381-94. doi: 10.2165/00007256-198704060-00001. No abstract available.
PubMed 3324256Godin G, Shephard RJ. A simple method to assess exercise behavior in the community. Can J Appl Sport Sci. 1985 Sep;10(3):141-6.
PubMed 4053261Ranson R, Stratton G, Taylor SR. Digit ratio (2D:4D) and physical fitness (Eurofit test battery) in school children. Early Hum Dev. 2015 May;91(5):327-31. doi: 10.1016/j.earlhumdev.2015.03.005. Epub 2015 Apr 4.
PubMed 25846842
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fitness Level in Short Stature Children and After Growth Hormone Treatment
- ClinicalTrials.gov ID
- NCT02977091
- Acronym / sponsor ID
- 0258-16-MMC
- Conditions
- Fitness
- Keywords
- short stature, fitness, children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- 15 Dec 2016 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 1 Mar 2019 (estimated)
- First posted
- 30 Nov 2016 (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.
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 .
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GH deficiency or idiopathic short stature | – | Other: change in fitness levelgrowth hormone (GH) deficiency or idiopathic short stature children before they start GH treatment |
| short stature | – | Other: change in fitness levelhealthy short children |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- short stature children
Key inclusion criteria (4 listed)
- short stature
- Physical healthy
- Mental healthy
- Capable to perform fitness test
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| change in fitness levelfitness 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 | Other | GH deficiency or idiopathic short stature, short stature |
Primary outcome
change in fitness level
Time frame: change of fitness levels from base line and after 6 month in short children
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2018.
- Background: PubMed 3324256Bar-Or O. The Wingate anaerobic test. An update on methodology, reliability and validity. Sports Med. 1987 Nov-Dec;4(6):381-94. doi: 10.2165/00007256-198704060-00001. No abstract available.
- Background: PubMed 4053261Godin G, Shephard RJ. A simple method to assess exercise behavior in the community. Can J Appl Sport Sci. 1985 Sep;10(3):141-6.
- Background: PubMed 25846842Ranson R, Stratton G, Taylor SR. Digit ratio (2D:4D) and physical fitness (Eurofit test battery) in school children. Early Hum Dev. 2015 May;91(5):327-31. doi: 10.1016/j.earlhumdev.2015.03.005. Epub 2015 Apr 4.
- The Eurofit Physical Fitness Test BatteryLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Nitsan Dror, MD principal investigator
senior in pediatric medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fitness, run by Meir 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 4 inclusion and 5 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 5 Oct 2018. 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?
Contact Nitsan Dror, MD (00972-9-7471910, nitzand@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in fitness level (time frame: change of fitness levels from base line and after 6 month in short children). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02977091, which also lists 3 linked publications.
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 5 Oct 2018.