Physical InactivityNCT05853770
Effects of Volleyball Intervention on Health-related Fitness in Primary School Students
A study testing TGfU volleyball intervention and Regular physical education classes in people with Physical Inactivity and Adolescent Obesity, run by University of Nis at 1 site in Serbia.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Inactivity, Adolescent Obesity, Physical Fitness
- What is being tested?
- TGfU volleyball intervention and Regular physical education classes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteSerbia
- Study dates
- 4 Feb 2018to 8 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of School-Based TGfU Volleyball Intervention on Physical Fitness and Body Composition in Primary School Students: A Cluster-Randomized Trial
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.
Read the detailed description
Eighty-eight healthy primary school students (mean age 13.3 years) were randomized to a TGfU volleyball intervention group (VG) or a control group (CG). CG participants attended three regular physical education (PE) classes per week, while VG participants attended two regular PE classes and a TGfU volleyball intervention that was implemented in the third PE class. The main part of each volleyball intervention session was based on the "Teaching Games for Understanding" (TGfU) model. This approach emphasizes the development of fundamental skills and tactical understanding of the game by utilizing modified games, such as small-sided games and mini-volleyball. By using this method, participants are able to increase their interaction with the ball and engage in moderate-to-vigorous gameplay intensity more frequently. The primary study outcomes were assessed before and after the 16-week intervention for both VG and CG participants. The main hypothesis is that implementation of the TGfU volleyball intervention in the physical education curriculum will lead to greater improvement in body composition and physical fitness outcomes among seventh-grade primary school students compared to those who receive traditional physical education classes, demonstrating that this intervention can be an effective method for reducing adiposity and promoting physical fitness levels among adolescents.
- Conditions
- Physical Inactivity, Adolescent Obesity, Physical Fitness, Body Composition, Healthy Lifestyle, Exercise
- Being tested
- TGfU volleyball intervention, Regular physical education classes
- Keywords
- physical activity, exercise training, physical education, volleyball, small-sided games, health-related fitness, body composition, physical fitness, adolescents, primary school
- Medical subject headings
- Sedentary Behavior, Pediatric Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TGfU volleyball interventionOther
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).
Regular physical education classesOther
Regular physical education classes following national physical education curriculum for second semester of seventh grade in primary school in Serbia.
| Study group | Role | What they receive |
|---|---|---|
| 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 . Receives: 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. Receives: Other: Regular physical education classes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, after 16 weeks
Secondary outcomes (9)
Change in Flexibility
Sit-and-Reach test is used for flexibility assessment. Measurements are recorded to the nearest centimeter.
Measured: Baseline, after 16 weeks
Change in Speed
Sprinting abilities are assessed through a 30 m sprint test. Sprinting times are recorded with an accuracy of 0.01 seconds.
Measured: Baseline, after 16 weeks
Change in Strength
Lower limb explosive strength is assessed through vertical jump tests, squat and countermovement jumps. Jump heights were recorded to the nearest centimeter.
Measured: Baseline, after 16 weeks
Change in Agility
Agility is assessed utilizing Agility T-test. Time taken to finish the test was recorded with an accuracy of 0.01 seconds.
Measured: Baseline, after 16 weeks
Change in Body Fat Percentage
Total body fat percentage assessed using bioelectric impendence method.
Measured: Baseline, after 16 weeks
Change in Body Weight
Body Weight assessed using digital scale and recorded in kilograms.
Measured: Baseline, after 16 weeks
Change in BMI
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).
Measured: Baseline, after 16 weeks
Change in Muscle Mass Percentage
Total muscle mass percentage in body, assessed using bioelectric impendence method.
Measured: Baseline, after 16 weeks
Change in Sum of skinfolds
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.
Measured: Baseline, after 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start4 Feb 2018
- Primary completion1 Jun 2018
- Study completion8 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical InactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nis
- Sponsor type
- University, hospital or other
- Collaborators
- University of Milan, University of Ljubljana, University of Banja Luka
- Responsible party
- Principal investigator, Darko Stojanovic, University of Nis
- Investigators
- Toplica Stojanovic, Study chair, University of Banja Luka
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05853770
- Sponsor's protocol ID
- 04-2100
- Status last verified
- May 2023
- First submitted
- 20 Apr 2023
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of School-Based TGfU Volleyball Intervention on Physical Fitness and Body Composition in Primary School Students: A Cluster-Randomized Trial
- ClinicalTrials.gov ID
- NCT05853770
- Acronym / sponsor ID
- 04-2100
- Conditions
- Physical Inactivity, Adolescent Obesity, Physical Fitness, Body Composition, Healthy Lifestyle, Exercise
- Keywords
- physical activity, exercise training, physical education, volleyball, small-sided games, health-related fitness, body composition, physical fitness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University of NisUniversity, hospital or other
- Collaborators
- University of Milan, University of Ljubljana, University of Banja Luka
- Study start
- 4 Feb 2018 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 8 Jun 2018 (actual)
- First posted
- 11 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Eighty-eight healthy primary school students (mean age 13.3 years) were randomized to a TGfU volleyball intervention group (VG) or a control group (CG). CG participants attended three regular physical education (PE) classes per week, while VG participants attended two regular PE classes and a TGfU volleyball intervention that was implemented in the third PE class. The main part of each volleyball intervention session was based on the "Teaching Games for Understanding" (TGfU) model. This approach emphasizes the development of fundamental skills and tactical understanding of the game by utilizing modified games, such as small-sided games and mini-volleyball. By using this method, participants are able to increase their interaction with the ball and engage in moderate-to-vigorous gameplay intensity more frequently. The primary study outcomes were assessed before and after the 16-week intervention for both VG and CG participants. The main hypothesis is that implementation of the TGfU volleyball intervention in the physical education curriculum will lead to greater improvement in body composition and physical fitness outcomes among seventh-grade primary school students compared to those who receive traditional physical education classes, demonstrating that this intervention can be an effective method for reducing adiposity and promoting physical fitness levels among adolescents.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TGfU volleyball intervention | Experimental | Other: TGfU volleyball interventionAccording 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 . |
| Control group | Active comparator | Other: Regular physical education classesControl 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. |
Who may qualify
- Ages
- 12 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TGfU volleyball interventionDuration 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). | Other | TGfU volleyball intervention |
| Regular physical education classesRegular physical education classes following national physical education curriculum for second semester of seventh grade in primary school in Serbia. | Other | Control group |
Primary outcome
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).
9 secondary outcomes
Change in Flexibility
Time frame: Baseline, after 16 weeks
Change in Speed
Time frame: Baseline, after 16 weeks
Change in Strength
Time frame: Baseline, after 16 weeks
Change in Agility
Time frame: Baseline, after 16 weeks
Change in Body Fat Percentage
Time frame: Baseline, after 16 weeks
Change in Body Weight
Time frame: Baseline, after 16 weeks
Change in BMI
Time frame: Baseline, after 16 weeks
Change in Muscle Mass Percentage
Time frame: Baseline, after 16 weeks
Change in Sum of skinfolds
Time frame: Baseline, after 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Toplica Stojanovic study chair
University of Banja Luka
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TGfU volleyball intervention and Regular physical education classes in people with Physical Inactivity and Adolescent Obesity, run by University of Nis at 1 site in Serbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cardiorespiratory Fitness (time frame: Baseline, after 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2023.