Physical ActivityFMSNCT03152968
To Observe Ability of Fundamental Movement Skills in School Children of Age 5 to 10-year-old in Udupi District
An observational study of Physical Activity, run by Manipal University at 1 site in India.
Trial summary
Fundamental movement skill is the precursor for physical activity in later life. Proficiency of Fundamental Movement Skills in Indian School Children is unknown. This observational trial shall tell us how proficient are our Udupi District Children. Read more about this study
- Who is it for?
- Ages 5 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- How many people
- 461 participants
- Where
- 1 siteIndia
- Study dates
- 1 May 2017to 31 May 2017
- How long will I take part?
- 1 Month
- 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 10 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children between age 5 to 10 years going to school in Udupi district, who will get consent sign from the parent will be included.
Who may be able to join
- All children in the age group 5 to 10 year old
Who cannot join
- Cerebral palsy
- Attention deficit/hyperactivity disorder
- Autism
Trial locations and contacts
1 site in 1 country.
India1 site
Center for Sport Science Medicine and Research
Udupi, Karnataka, 576104
About this study
Official title: Proficiency of Fundamental Movement Skills in 5 -10 Years Old School Children in Udupi District
Fundamental movement skill is the precursor for physical activity in later life. Proficiency of Fundamental Movement Skills in Indian School Children is unknown. This observational trial shall tell us how proficient are our Udupi District Children.
Read the detailed description
After IRC and IEC approval and approval from district educational officers, proper assent and consent will be given to the principal of the respective school.
1-week prior to the study, parents will be explained about the study during parent meeting and even school leaving and opening times, a parent who visits the school to drop their children will be addressed.
Children of age above 7 yr. will be explained the class about the study.
Inform sheets will be distributed after conveying the information.
Only the children who get an informed sheet signed will be included in the study.
- Conditions
- Physical Activity
- Keywords
- FMS
- Medical subject headings
- Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
Fundamental movement skill score
Satisfying the criterion of each skill such as run, jump, catch, throw
Measured: immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start1 May 2017
- Primary completion31 May 2017
- Study completion31 May 2017
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 Physical ActivityStudies 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 461 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Manipal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mayuri Gad, Manipal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03152968
- Sponsor's protocol ID
- REF/2017/05/014215
- Acronym
- FMS
- Status last verified
- Jun 2017
- First submitted
- 9 May 2017
- Last updated
- 2 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mukherjee S, Ting Jamie LC, Fong LH. Fundamental Motor Skill Proficiency of 6- to 9-Year-Old Singaporean Children. Percept Mot Skills. 2017 Jun;124(3):584-600. doi: 10.1177/0031512517703005. Epub 2017 Apr 4.
PubMed 28376671Birch S, Cummings L, Oxford SW, Duncan MJ. Examining Relative Age Effects in Fundamental Skill Proficiency in British Children Aged 6-11 Years. J Strength Cond Res. 2016 Oct;30(10):2809-15. doi: 10.1519/JSC.0000000000000526.
PubMed 24832979Morgan PJ, Barnett LM, Cliff DP, Okely AD, Scott HA, Cohen KE, Lubans DR. Fundamental movement skill interventions in youth: a systematic review and meta-analysis. Pediatrics. 2013 Nov;132(5):e1361-83. doi: 10.1542/peds.2013-1167. Epub 2013 Oct 28.
PubMed 24167179
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proficiency of Fundamental Movement Skills in 5 -10 Years Old School Children in Udupi District
- ClinicalTrials.gov ID
- NCT03152968
- Acronym / sponsor ID
- FMS / REF/2017/05/014215
- Conditions
- Physical Activity
- Keywords
- FMS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 461 participants (actual)
- Lead sponsor
- Manipal UniversityUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 31 May 2017 (actual)
- First posted
- 15 May 2017 (actual)
- 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.
Fundamental movement skill is the precursor for physical activity in later life. Proficiency of Fundamental Movement Skills in Indian School Children is unknown. This observational trial shall tell us how proficient are our Udupi District Children.
Detailed description
After IRC and IEC approval and approval from district educational officers, proper assent and consent will be given to the principal of the respective school.
1-week prior to the study, parents will be explained about the study during parent meeting and even school leaving and opening times, a parent who visits the school to drop their children will be addressed.
Children of age above 7 yr. will be explained the class about the study.
Inform sheets will be distributed after conveying the information.
Only the children who get an informed sheet signed will be included in the study.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children between age 5 to 10 years going to school in Udupi district, who will get consent sign from the parent will be included.
Key inclusion criteria (1 listed)
- All children in the age group 5 to 10 year old
Key exclusion criteria (3 listed)
- Cerebral palsy
- Attention deficit/hyperactivity disorder
- Autism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fundamental movement skill score
Time frame: immediate
Satisfying the criterion of each skill such as run, jump, catch, throw
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2017.
- Results publication: PubMed 28376671Mukherjee S, Ting Jamie LC, Fong LH. Fundamental Motor Skill Proficiency of 6- to 9-Year-Old Singaporean Children. Percept Mot Skills. 2017 Jun;124(3):584-600. doi: 10.1177/0031512517703005. Epub 2017 Apr 4.
- Results publication: PubMed 24832979Birch S, Cummings L, Oxford SW, Duncan MJ. Examining Relative Age Effects in Fundamental Skill Proficiency in British Children Aged 6-11 Years. J Strength Cond Res. 2016 Oct;30(10):2809-15. doi: 10.1519/JSC.0000000000000526.
- Results publication: PubMed 24167179Morgan PJ, Barnett LM, Cliff DP, Okely AD, Scott HA, Cohen KE, Lubans DR. Fundamental movement skill interventions in youth: a systematic review and meta-analysis. Pediatrics. 2013 Nov;132(5):e1361-83. doi: 10.1542/peds.2013-1167. Epub 2013 Oct 28.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Physical Activity, run by Manipal University at 1 site in India.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 2 Jun 2017. 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 India. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fundamental movement skill score (time frame: immediate). 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 NCT03152968, 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 2 Jun 2017.