NCT04734964

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2018

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 2, 2021

Completed
Last Updated

February 2, 2021

Status Verified

January 1, 2021

Enrollment Period

2 months

First QC Date

January 25, 2021

Last Update Submit

January 29, 2021

Conditions

Fine Motor SkillsTestosterone Concentration

Keywords

school, cardiovascular exercise, coordinative exercise

Outcome Measures

Primary Outcomes (2)

  • 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)

    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).

    baseline and week 10

Secondary Outcomes (3)

  • Hand-eye coordination assessed by the Hand-eye coordination test

    baseline and week 10

  • static balance assessed by the Flamingo balance test

    baseline and week 10

  • Cardiorespiratory fitness assessed by the Shuttle Run Test

    baseline and week 10

Study Arms (3)

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.

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.

Behavioral: exercise training

Interventions

exercise trainingBEHAVIORAL

Exercise training session for 45 minutes.

Cardiovascular exercise groupCoordinative exercise group

Eligibility Criteria

Age12 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • absence of physical impairment (e.g. traumatic injury)
  • absence of mental impairment (e.g. mental retardation)
  • no consumption of psychotropic medications

You may not qualify if:

  • restrictions to do exercises (based on Medical certificate issued by the Physician)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lithuanian Sports University

Kaunas, Lithuania

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Juste Knatauskaite

    Lithuanian Sports University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2021

First Posted

February 2, 2021

Study Start

January 15, 2018

Primary Completion

March 30, 2018

Study Completion

September 28, 2018

Last Updated

February 2, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

LI(1)