Fundamental Movement Skill CompetenceNCT04458844
Strength and Fundamental Movement Skill (FMS) Training in Children
A study testing Exercise in people with Fundamental Movement Skill Competence, run by Teesside University at 1 site in United Kingdom.
Trial summary
Competence in Fundamental movement skills (FMS) is essential to enable children to be physical active. The aim of this study was to investigate the effects of integrated FMS skill training (balancing and stabilisation skills, locomotor skills [e.g. run, hop, jump, crawl] and object control / manipulation [e.g. Read more about this study
- Who is it for?
- Ages 10 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Fundamental Movement Skill Competence
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2018to 30 Aug 2018
- 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 10 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 10 - 11 years in a participating primary school (cluster) for which the Head Teacher has provided consent.
- Parental consent received
Who cannot join
- No parental consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Teesside University
Middlesbrough, England, TS1 3BX
About this study
Official title: Integrated Strength and Fundamental Movement Skill (FMS) Training in Children: a Pilot Study
Competence in Fundamental movement skills (FMS) is essential to enable children to be physical active. The aim of this study was to investigate the effects of integrated FMS skill training (balancing and stabilisation skills, locomotor skills [e.g. run, hop, jump, crawl] and object control / manipulation [e.g. dribbling, rolling, striking, kicking and catching i.e. a ball] with strength training on FMS performance in children.
- Conditions
- Fundamental Movement Skill Competence
- Being tested
- Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Intervention programmes were designed based on previous research (Duncan, et al., 2017; Faigenbaum, et al., 2011; Miller, et al., 2006) to ensure all exercises were developmentally appropriate for the age of the participants (an example session plan can be seen in the supplementary material). Each session consisted of five activities and lasted 50 - 60 minutes. Three out of the five activities were identical for the FMS and FMS+ groups, while two differed focusing on skill development for the FMS group and strength development for the FMS+ group. The FMS and FMS+ group received their sessions twice a week for 4 weeks. The sessions were delivered at least 48 hours apart to allow recovery and to reduce the risk of fatigue effecting performance (Faigenbaum, et al., 1996). All sessions were led by a researcher and a qualified sports coach.
| Study group | Role | What they receive |
|---|---|---|
| Fundamental Movement Skill (FMS) Training | Experimental | Exercise 2 x per week focusing on Fundamental Movement Skill Development Receives: Other: Exercise |
| FMS and strength | Experimental | Replacement of 50% FMS training with integrated strength training. Receives: Other: Exercise |
| Control | No intervention | No intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in product-process assessment of FMS via the Canadian agility and movement skills assessment (CAMSA)
The Canadian agility and movement skills assessment (CAMSA), which combines product- and process-oriented outcomes was used to assess FMS. Full details of the CAMSA can be found in the Canadian Assessment of Physical Literacy Manual, 2017. Briefly, the CAMSA requires participants to travel a total distance of 20m while completing seven different movement skill tasks (Longmuir et al 2017) around an agility style course. Process oriented criteria were used to assess the performance of each movement skill. In addition, the throw and kick were scored as either hitting or missing a target 5m away (product assessment). Finally, the overall time taken to complete the course was recorded (product assessment) and converted into a timed score using pre-defined time criteria scores. The CAMSA raw score was calculated by adding the individual skill scores (max of 14 points) and the time criteria score (max of 14 points) giving an individual score between 1 and 28 points.
Measured: Baseline data was collected mid-June 2018 at the primary schools, one week prior to the intervention. Post testing data collection was in the week immediately after the final week of the four week intervention.
Secondary outcomes (2)
Change in product assessment of FMS
The investigators assessed locomotor performance through a countermovement jump and sprint assessments. Jump height was calculating from flight time measured by the Optojump Next (Microgate, Italy). Children were allowed up to three trial repetitions before completing three maximal jumps with the best performance used for analysis. Jumps were not counted if the children tucked their legs in the air or landing outside of the 1m square testing area. Sprint times were recorded over a distance of 40m to the nearest 0.01 second using an infrared timing gate system (Brower timing systems, Draper, USA). Sprints were repeated three times and the best score taken for analysis.
Measured: Baseline data was collected mid-June 2018 at the primary schools, one week prior to the intervention. Post testing data collection was in the week immediately after the final week of the four week intervention.
Change in strength
Grip strength (Takei Grip-D) and counter movement jump (CMJ) (Optojump Next, Microgate, Italy) were recorded as measures of upper and lower body strength, respectively. The children followed a set of standardised instructions and completed three attempts on each test to give an average score for each test.
Measured: Baseline data was collected mid-June 2018 at the primary schools, one week prior to the intervention. Post testing data collection was in the week immediately after the final week of the four week intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start1 Mar 2018
- Primary completion22 Jul 2018
- Study completion30 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fundamental Movement Skill CompetenceStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Cluster randomised control trial.
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teesside University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Wright, Teesside University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04458844
- Sponsor's protocol ID
- SSSBLRECSTUD1449
- Status last verified
- Jul 2020
- First submitted
- 29 Jun 2020
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Strength and Fundamental Movement Skill (FMS) Training in Children: a Pilot Study
- ClinicalTrials.gov ID
- NCT04458844
- Acronym / sponsor ID
- SSSBLRECSTUD1449
- Conditions
- Fundamental Movement Skill Competence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Teesside UniversityUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 22 Jul 2018 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 7 Jul 2020 (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.
Competence in Fundamental movement skills (FMS) is essential to enable children to be physical active. The aim of this study was to investigate the effects of integrated FMS skill training (balancing and stabilisation skills, locomotor skills [e.g. run, hop, jump, crawl] and object control / manipulation [e.g. dribbling, rolling, striking, kicking and catching i.e. a ball] with strength training on FMS performance in children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Cluster randomised control trial.
| Arm | Type | Receives |
|---|---|---|
| Fundamental Movement Skill (FMS) Training | Experimental | Other: ExerciseExercise 2 x per week focusing on Fundamental Movement Skill Development |
| FMS and strength | Experimental | Other: ExerciseReplacement of 50% FMS training with integrated strength training. |
| Control | No intervention | –No intervention. |
Who may qualify
- Ages
- 10 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age 10 - 11 years in a participating primary school (cluster) for which the Head Teacher has provided consent.
- Parental consent received
Key exclusion criteria (1 listed)
- No parental consent
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 |
|---|---|---|
| ExerciseIntervention programmes were designed based on previous research (Duncan, et al., 2017; Faigenbaum, et al., 2011; Miller, et al., 2006) to ensure all exercises were developmentally appropriate for the age of the participants (an example session plan can be seen in the supplementary material). Each session consisted of five activities and lasted 50 - 60 minutes. Three out of the five activities were identical for the FMS and FMS+ groups, while two differed focusing on skill development for the FMS group and strength development for the FMS+ group. The FMS and FMS+ group received their sessions twice a week for 4 weeks. The sessions were delivered at least 48 hours apart to allow recovery and to reduce the risk of fatigue effecting performance (Faigenbaum, et al., 1996). All sessions were led by a researcher and a qualified sports coach. | Other | FMS and strength, Fundamental Movement Skill (FMS) Training |
Primary outcome
Change in product-process assessment of FMS via the Canadian agility and movement skills assessment (CAMSA)
Time frame: Baseline data was collected mid-June 2018 at the primary schools, one week prior to the intervention. Post testing data collection was in the week immediately after the final week of the four week intervention.
The Canadian agility and movement skills assessment (CAMSA), which combines product- and process-oriented outcomes was used to assess FMS. Full details of the CAMSA can be found in the Canadian Assessment of Physical Literacy Manual, 2017. Briefly, the CAMSA requires participants to travel a total distance of 20m while completing seven different movement skill tasks (Longmuir et al 2017) around an agility style course. Process oriented criteria were used to assess the performance of each movement skill. In addition, the throw and kick were scored as either hitting or missing a target 5m away (product assessment). Finally, the overall time taken to complete the course was recorded (product assessment) and converted into a timed score using pre-defined time criteria scores. The CAMSA raw score was calculated by adding the individual skill scores (max of 14 points) and the time criteria score (max of 14 points) giving an individual score between 1 and 28 points.
2 secondary outcomes
Change in product assessment of FMS
Time frame: Baseline data was collected mid-June 2018 at the primary schools, one week prior to the intervention. Post testing data collection was in the week immediately after the final week of the four week intervention.
Change in strength
Time frame: Baseline data was collected mid-June 2018 at the primary schools, one week prior to the intervention. Post testing data collection was in the week immediately after the final week of the four week intervention.
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 7 Jul 2020.
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?
A study testing Exercise in people with Fundamental Movement Skill Competence, run by Teesside University at 1 site in United Kingdom.
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: finished, as of the sponsor's last update on 7 Jul 2020. 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 United Kingdom. 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?
Change in product-process assessment of FMS via the Canadian agility and movement skills assessment (CAMSA) (time frame: Baseline data was collected mid-June 2018 at the primary schools, one week prior to the intervention. Post testing data collection was in the week immediately after the final week of the four week intervention.). 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 7 Jul 2020.