NCT07393789

Brief Summary

This study examines the effects of a 16-week structured physical activity program on physical fitness, steps number, and body mass index in children aged 8 to 10 years. Participants were randomly assigned to either an intervention group that participated in the physical activity program or a control group that continued with their usual daily activities without additional intervention. Physical fitness outcomes include standing broad jump, handgrip strength, and 20-meter shuttle run performance. Body mass index is calculated from measured height and body mass. The goal of the study is to determine whether participation in a multicomponent physical activity intervention leads to greater improvements in physical fitness, steps number, and body composition compared with no additional intervention.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
178

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
2 countries

2 active sites

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

October 31, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2023

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

January 31, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 6, 2026

Completed
Last Updated

February 6, 2026

Status Verified

January 1, 2026

Enrollment Period

4 months

First QC Date

January 31, 2026

Last Update Submit

January 31, 2026

Conditions

Keywords

Pretest-Posttest StudyRandomized Control Trialphysical activity intervention, children, preadolescents, physical fitness, body mass index, school-based intervention

Outcome Measures

Primary Outcomes (3)

  • Handgrip Strength

    Handgrip Strength in kg

    Baseline and 16 weeks

  • Standing Broad Jump Distance

    Assessment of lower-body muscular power measured in centimeters

    Baseline and 16 weeks

  • 20-Meter Shuttle Run Performance

    20-Meter Shuttle Run result in seconds

    Baseline and 16 weeks

Secondary Outcomes (1)

  • Body Mass Index (BMI)

    Baseline and 16 weeks

Study Arms (2)

Physical Activity Intervention Group

EXPERIMENTAL

Participants receive a 16-week structured multicomponent physical activity program.

Behavioral: Multicomponent Physical Activity Program

Control Group

NO INTERVENTION

Participants continue their usual daily activities without additional intervention.

Interventions

Structured physical activity sessions and motivational procedures designed to improve muscular strength, cardiorespiratory fitness, speed, and coordination.

Physical Activity Intervention Group

Eligibility Criteria

Age8 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 8 to 10 years.
  • Enrollment in regular primary school.
  • Written informed consent obtained from parent or legal guardian.
  • Ability to participate in physical education and physical activity.

You may not qualify if:

  • Medical conditions or physical disabilities that limit participation in physical activity.
  • Acute illness or injury at the time of testing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Zakladni skola Travnik

Přerov, Czechia

Location

University of Belgrade - Faculty of Sport and Physical Education

Belgrade, 11000, Serbia

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned to either an intervention group or a control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

January 31, 2026

First Posted

February 6, 2026

Study Start

October 31, 2022

Primary Completion

March 3, 2023

Study Completion

March 3, 2023

Last Updated

February 6, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations