- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04734964
Effect of Exercise Training on Fine Motor Skills
Effect of Two Types of Exercise Training on Fine Motor Skills in Adolescents: Association With Testosterone
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Kaunas, Lithuania
- Lithuanian Sports University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- absence of physical impairment (e.g. traumatic injury)
- absence of mental impairment (e.g. mental retardation)
- no consumption of psychotropic medications
Exclusion Criteria:
• restrictions to do exercises (based on Medical certificate issued by the Physician)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group
Participants underwent only common physical education classes twice per week for 45 minutes each and no additional after-school exercises.
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|
|
Experimental: Coordinative exercise group
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.
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Exercise training session for 45 minutes.
|
|
Experimental: Cardiovascular exercise group
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.
|
Exercise training session for 45 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
baseline and week 10
|
|
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).
|
baseline and week 10
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hand-eye coordination assessed by the Hand-eye coordination test
Time Frame: baseline and week 10
|
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).
|
baseline and week 10
|
|
static balance assessed by the Flamingo balance test
Time Frame: baseline and week 10
|
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)
|
baseline and week 10
|
|
Cardiorespiratory fitness assessed by the Shuttle Run Test
Time Frame: baseline and week 10
|
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).
|
baseline and week 10
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Juste Knatauskaite, Lithuanian Sports University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- LithuanianSportsU-5
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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