- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05853770
Effects of Volleyball Intervention on Health-related Fitness in Primary School Students
Effects of School-Based TGfU Volleyball Intervention on Physical Fitness and Body Composition in Primary School Students: A Cluster-Randomized Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Niš, Serbia, 18000
- Primary School "Dušan Radović"
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: TGfU volleyball intervention
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 . |
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). |
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Active Comparator: Control group
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.
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Regular physical education classes following national physical education curriculum for second semester of seventh grade in primary school in Serbia.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Cardiorespiratory Fitness
Time Frame: Baseline, after 16 weeks
|
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).
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Baseline, after 16 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Flexibility
Time Frame: Baseline, after 16 weeks
|
Sit-and-Reach test is used for flexibility assessment.
Measurements are recorded to the nearest centimeter.
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Baseline, after 16 weeks
|
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Change in Speed
Time Frame: Baseline, after 16 weeks
|
Sprinting abilities are assessed through a 30 m sprint test.
Sprinting times are recorded with an accuracy of 0.01 seconds.
|
Baseline, after 16 weeks
|
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Change in Strength
Time Frame: Baseline, after 16 weeks
|
Lower limb explosive strength is assessed through vertical jump tests, squat and countermovement jumps.
Jump heights were recorded to the nearest centimeter.
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Baseline, after 16 weeks
|
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Change in Agility
Time Frame: Baseline, after 16 weeks
|
Agility is assessed utilizing Agility T-test.
Time taken to finish the test was recorded with an accuracy of 0.01 seconds.
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Baseline, after 16 weeks
|
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Change in Body Fat Percentage
Time Frame: Baseline, after 16 weeks
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Total body fat percentage assessed using bioelectric impendence method.
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Baseline, after 16 weeks
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Change in Body Weight
Time Frame: Baseline, after 16 weeks
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Body Weight assessed using digital scale and recorded in kilograms.
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Baseline, after 16 weeks
|
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Change in BMI
Time Frame: Baseline, after 16 weeks
|
Body Mass Index (BMI) is calculated by dividing a person's weight in kilograms by the square of their height in meters.
BMI = weight (kg) / height^2 (m^2).
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Baseline, after 16 weeks
|
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Change in Muscle Mass Percentage
Time Frame: Baseline, after 16 weeks
|
Total muscle mass percentage in body, assessed using bioelectric impendence method.
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Baseline, after 16 weeks
|
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Change in Sum of skinfolds
Time Frame: Baseline, after 16 weeks
|
Measurements of skinfold thicknesses were obtained using calibrated caliper at five skinfold sites calf, suprailiac, subscapular, triceps, and biceps (recorded in mm).
The sum of skinfolds was calculated by summing the thicknesses of all five skinfold sites.
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Baseline, after 16 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Toplica Stojanovic, University of Banja Luka
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 (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 04-2100
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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