NCT05853770

Brief Summary

The goal of this study is to find out if doing a 16-week volleyball program integrated in physical education classes at school can make primary school students stronger, faster, and have better endurance. The study also wants to see whether the program can lead to changes in the students' body weight, body fat, and muscle mass.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 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

February 4, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2018

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

April 20, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 11, 2023

Completed
Last Updated

May 11, 2023

Status Verified

May 1, 2023

Enrollment Period

4 months

First QC Date

April 20, 2023

Last Update Submit

May 2, 2023

Conditions

Keywords

physical activityexercise trainingphysical educationvolleyballsmall-sided gameshealth-related fitnessbody compositionphysical fitnessadolescentsprimary school

Outcome Measures

Primary Outcomes (1)

  • Change in Cardiorespiratory Fitness

    Cardiorespiratory fitness is considered one of the most powerful health-related markers in adolescents. In this study, cardiorespiratory fitness is assessed using the 20-m shuttle-run test, which was adopted from the Eurofit test battery. Scoring is obtained as VO2max values (mL/kg/min).

    Baseline, after 16 weeks

Secondary Outcomes (9)

  • Change in Flexibility

    Baseline, after 16 weeks

  • Change in Speed

    Baseline, after 16 weeks

  • Change in Strength

    Baseline, after 16 weeks

  • Change in Agility

    Baseline, after 16 weeks

  • Change in Body Fat Percentage

    Baseline, after 16 weeks

  • +4 more secondary outcomes

Study Arms (2)

TGfU volleyball intervention

EXPERIMENTAL

According to the national curriculum, children in Serbia must attend three regular physical education (PE) classes per week. Besides attending two regular PE classes, participants in the experimental group also followed a 16-week TGfU volleyball intervention that was implemented during the third PE class. The total number of sessions: 32 regular PE + 16 TGfU volleyball intervention .

Other: TGfU volleyball intervention

Control group

ACTIVE COMPARATOR

Control group (CG) participants followed the national physical education curriculum. The CG participants conducted three regular PE classes per week or 48 regular PE classes in total.

Other: Regular physical education classes

Interventions

Duration of intervention: 16 week; Duration of each session: 45 minutes; Frequency: One session per week during the third PE class; The structure of each TGfU session had three parts: The introduction part comprised 10 minutes of moderate-intensity warm-up activities; The main part comprised mini-volleyball and small-sided games (25-30 minutes); The last part of the session was the cool-down period (5 min).

TGfU volleyball intervention

Regular physical education classes following national physical education curriculum for second semester of seventh grade in primary school in Serbia.

Control group

Eligibility Criteria

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

You may qualify if:

  • seventh grade primary school students
  • were not exempt from participating in physical education classes
  • did not have any health conditions (pediatric disease, orthopedic conditions, injuries, respiratory or cardiovascular disease)
  • voluntary participation
  • obtained informed consent from parents or legal guardians

You may not qualify if:

  • exempted from participating in physical education classes
  • currently participating in other interventions
  • the presence of acute or chronic infectious disease
  • the presence of injury
  • not able to attend all intervention sessions
  • not obtaining informed consent from parents or legal guardians
  • do not want to participate voluntary

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Primary School "Dušan Radović"

Niš, 18000, Serbia

Location

MeSH Terms

Conditions

Sedentary BehaviorPediatric ObesityMotor Activity

Condition Hierarchy (Ancestors)

BehaviorObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Toplica Stojanovic

    University of Banja Luka

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 20, 2023

First Posted

May 11, 2023

Study Start

February 4, 2018

Primary Completion

June 1, 2018

Study Completion

June 8, 2018

Last Updated

May 11, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations