Fine Motor SkillsNCT04734964
Effect of Exercise Training on Fine Motor Skills
A study testing exercise training in people with Fine Motor Skills and Testosterone Concentration, run by Lithuanian Sports University at 1 site in Lithuania.
Trial summary
Despite the importance of physical activity for adolescent physical development, the specific impact of different types of exercise training on fine motor skills and testosterone concentration is unknown. Read more about this study
- Who is it for?
- Ages 12 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Fine Motor Skills, Testosterone Concentration
- What is being tested?
- exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteLithuania
- Study dates
- 15 Jan 2018to 28 Sep 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 12 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- absence of physical impairment (e.g. traumatic injury)
- absence of mental impairment (e.g. mental retardation)
- no consumption of psychotropic medications
Who cannot join
- restrictions to do exercises (based on Medical certificate issued by the Physician)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Two Types of Exercise Training on Fine Motor Skills in Adolescents: Association With Testosterone
Despite the importance of physical activity for adolescent physical development, the specific impact of different types of exercise training on fine motor skills and testosterone concentration is unknown. A primary aim of this study was to analyze the benefits of cardiovascular and coordinative exercise training on fine motor skills in an adolescent population. A second aim of our study was to determine the testosterone concentration after physical stress of cardiovascular and coordinative exercise training and if testosterone was related to fine motor skills among adolescents following an exercise training intervention.
Read the detailed description
We assigned 135 adolescents (68 girls, 12-15 years of age) from Lithuania. Adolescents were assigned to one of three groups: control group (CON) (n = 46; 23 girls), coordinative exercise (CE) (n = 41; 22 girls), and cardiovascular exercise (CVE) group (n = 48; 23 girls). Participants performed all necessary tests according to the study protocol one week before the intervention. Adolescents were familiarized with the tests on a separate day before the first assessment. A second set of tests was performed one week after the 10-week exercise intervention.
The exercise intervention period was 10 weeks. Exercises were led by a Physical Education teacher. Experimental groups had common physical education classes twice per week for 45 minutes each, and additional exercise sessions were held three times per week for 45 minutes after school.
- Conditions
- Fine Motor Skills, Testosterone Concentration
- Being tested
- exercise training
- Keywords
- school, cardiovascular exercise, coordinative exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise trainingBehavioural
Exercise training session for 45 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Participants underwent only common physical education classes twice per week for 45 minutes each and no additional after-school exercises. |
| Coordinative exercise group | Experimental | Participants had common physical education classes twice per week for 45 minutes each, and additional exercise sessions were held three times per week for 45 minutes after school. Receives: Behavioral: exercise training |
| Cardiovascular exercise group | Experimental | Participants had common physical education classes twice per week for 45 minutes each, and additional exercise sessions were held three times per week for 45 minutes after school. Receives: Behavioral: exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fine motor skills assessed by the Flower trail test
Flower trail test was used to assess fine motor skills. The participant has to draw a line between two solid lines as accurately as possible and without lifting a pen. A higher score in the flower trail test means more mistakes made. Change = (week 10 score - baseline score)
Measured: baseline and week 10
Salivary testosterone concentration
Hormone concentration within the saliva sample was measured using the enzyme-linked immunosorbent assay (IBL, Hamburg, Germany). Change = (week 10 score - baseline score).
Measured: baseline and week 10
Secondary outcomes (3)
Hand-eye coordination assessed by the Hand-eye coordination test
Participant has to throw a tennis ball against a wall and catch and repeat this for 30 seconds. A number of successful catches is recorded, higher score shows better coordination. Change = (week 10 score - baseline score).
Measured: baseline and week 10
static balance assessed by the Flamingo balance test
Flamingo balance test is used to assess static balance. Every attempt to maintain balance for 1 minute is counted as a score. Small values (closer to 1) indicate a better balance. Change = (week 10 score - baseline score)
Measured: baseline and week 10
Cardiorespiratory fitness assessed by the Shuttle Run Test
On this test, the participant must run back and forth between two lines (20 meters apart) with increasing intensity. Higher score means a better cardiorespiratory fitness. Change = (week 10 score - baseline score).
Measured: baseline and week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start15 Jan 2018
- Primary completion30 Mar 2018
- Study completion28 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fine Motor SkillsStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lithuanian Sports University
- Sponsor type
- University, hospital or other
- Collaborators
- Medical School Hamburg
- Responsible party
- Sponsor
- Investigators
- Juste Knatauskaite, Principal investigator, Lithuanian Sports University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04734964
- Sponsor's protocol ID
- LithuanianSportsU-5
- Status last verified
- Jan 2021
- First submitted
- 25 Jan 2021
- Last updated
- 2 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Two Types of Exercise Training on Fine Motor Skills in Adolescents: Association With Testosterone
- ClinicalTrials.gov ID
- NCT04734964
- Acronym / sponsor ID
- LithuanianSportsU-5
- Conditions
- Fine Motor Skills, Testosterone Concentration
- Keywords
- school, cardiovascular exercise, coordinative exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Lithuanian Sports UniversityUniversity, hospital or other
- Collaborators
- Medical School Hamburg
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 28 Sep 2018 (actual)
- First posted
- 2 Feb 2021 (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.
Despite the importance of physical activity for adolescent physical development, the specific impact of different types of exercise training on fine motor skills and testosterone concentration is unknown. A primary aim of this study was to analyze the benefits of cardiovascular and coordinative exercise training on fine motor skills in an adolescent population. A second aim of our study was to determine the testosterone concentration after physical stress of cardiovascular and coordinative exercise training and if testosterone was related to fine motor skills among adolescents following an exercise training intervention.
Detailed description
We assigned 135 adolescents (68 girls, 12-15 years of age) from Lithuania. Adolescents were assigned to one of three groups: control group (CON) (n = 46; 23 girls), coordinative exercise (CE) (n = 41; 22 girls), and cardiovascular exercise (CVE) group (n = 48; 23 girls). Participants performed all necessary tests according to the study protocol one week before the intervention. Adolescents were familiarized with the tests on a separate day before the first assessment. A second set of tests was performed one week after the 10-week exercise intervention.
The exercise intervention period was 10 weeks. Exercises were led by a Physical Education teacher. Experimental groups had common physical education classes twice per week for 45 minutes each, and additional exercise sessions were held three times per week for 45 minutes after school.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Participants underwent only common physical education classes twice per week for 45 minutes each and no additional after-school exercises. |
| Coordinative exercise group | Experimental | Behavioral: exercise trainingParticipants had common physical education classes twice per week for 45 minutes each, and additional exercise sessions were held three times per week for 45 minutes after school. |
| Cardiovascular exercise group | Experimental | Behavioral: exercise trainingParticipants had common physical education classes twice per week for 45 minutes each, and additional exercise sessions were held three times per week for 45 minutes after school. |
Who may qualify
- Ages
- 12 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- absence of physical impairment (e.g. traumatic injury)
- absence of mental impairment (e.g. mental retardation)
- no consumption of psychotropic medications
Key exclusion criteria (1 listed)
- restrictions to do exercises (based on Medical certificate issued by the Physician)
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 |
|---|---|---|
| exercise trainingExercise training session for 45 minutes. | Behavioural | Cardiovascular exercise group, Coordinative exercise group |
Primary outcome
Fine motor skills assessed by the Flower trail test
Time frame: baseline and week 10
Flower trail test was used to assess fine motor skills. The participant has to draw a line between two solid lines as accurately as possible and without lifting a pen. A higher score in the flower trail test means more mistakes made. Change = (week 10 score - baseline score)
Salivary testosterone concentration
Time frame: baseline and week 10
Hormone concentration within the saliva sample was measured using the enzyme-linked immunosorbent assay (IBL, Hamburg, Germany). Change = (week 10 score - baseline score).
3 secondary outcomes
Hand-eye coordination assessed by the Hand-eye coordination test
Time frame: baseline and week 10
static balance assessed by the Flamingo balance test
Time frame: baseline and week 10
Cardiorespiratory fitness assessed by the Shuttle Run Test
Time frame: baseline and week 10
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 Feb 2021.
- 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.
Juste Knatauskaite principal investigator
Lithuanian Sports University
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 training in people with Fine Motor Skills and Testosterone Concentration, run by Lithuanian Sports University at 1 site in Lithuania.
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 3 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 2 Feb 2021. 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 Lithuania. 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?
Fine motor skills assessed by the Flower trail test (time frame: baseline and week 10). 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 Feb 2021.