Physical FitnessEDUFITNCT01098968
Education and Fitness: EDUFIT Study
A study testing Physical activity program in people with Physical Fitness and Body Composition, run by Universidad de Granada at 2 sites in Spain.
Trial summary
EDUFIT is a group-Randomized Controlled Trial specifically designed to enhance physical fitness and other health-related factors in a school setting in adolescents. Read more about this study
- Who is it for?
- Ages 12 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Fitness, Body Composition, Lipid Metabolism
- What is being tested?
- Physical activity program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesSpain
- Study dates
- Jan 2007to Sep 2007
- 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
- Adolescents enrolled in the Spanish Educational System, free of any muscle-skeletal problem not allowing take part in Physical Education lessons or fitness testing.
Who cannot join
- Clinical diagnosis of diabetes
- Pregnancy
- Drugs/alcohol abuse
- In general, any chronic disease that does not permit the person to perform exercise and physical education lessons.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
IES Alcántara (Consejería de Educación, Formación y Empleo de la Región de Murcia)
Alcantarilla, Murcia, 30820
University of Granada
Granada, Granada, 18071
About this study
Official title: Effects of a Physical Education Program Focused on Improving Physical Fitness in Adolescents Aged 12-14 Years
EDUFIT is a group-Randomized Controlled Trial specifically designed to enhance physical fitness and other health-related factors in a school setting in adolescents.
Read the detailed description
Physical fitness is a powerful marker of cardiovascular health already at early stages in life. To promote physical fitness enhancement from the school is therefore needed and this is the main aim of the EDUFIT study (EDUcation for FITness).
The participants were randomly allocated to control group (CG), experimental group 1 (EG1) and experimental group 2 (EG2). The CG received 2 physical education sessions/week, the EG1 received 4 physical education sessions/week (volume increased) and the EG2 received 4 physical education sessions/week of high intensity (volume+intensity increased). Several health-related parameters were assessed before and after a 16-weeks intervention: physical fitness (primary outcome), body composition (secondary), and lipid-metabolic profile, ventilatory parameters, blood pressure, and cognitive and academic performance (tertiary outcomes).
The hypothesis of the EDUFIT project was that to double the number of physical education classes will improve physical fitness in adolescents. The confirmation of the hypothesis could have important public health implications.
- Conditions
- Physical Fitness, Body Composition, Lipid Metabolism
- Being tested
- Physical activity program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity programBehavioural
School intervention program specifically designed to increase health-related physical fitness
| Study group | Role | What they receive |
|---|---|---|
| Normal PE | No intervention | 2 Physical Education sessions / week |
| PE Volume | Experimental | 4 Physical Education sessions/week (increased volume) Receives: Behavioral: Physical activity program |
| PE Volume + Intensity | Experimental | 4 Physical Education sessions/week of high intensity (increased volume and intensity) Receives: Behavioral: Physical activity program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related physical fitness
Cardiorespiratory fitness; musculoskeletal fitness; motor fitness.
Measured: 4 months
Secondary outcomes (1)
Cardiovascular disease risk factors
Body composition; lipid-metabolic profile; blood pressure; ventilatory parameters.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2010 (estimated)
- Study startJan 2007
- Primary completionJun 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Physical FitnessStudies 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
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Investigators
- Francisco B Ortega Porcel, PhD, Principal investigator, University of Granada (Spain)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01098968
- Sponsor's protocol ID
- EDUFIT
- Acronym
- EDUFIT
- Status last verified
- Sep 2010
- First submitted
- 2 Apr 2010
- Last updated
- 8 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Ortega FB, Ruiz JR, Castillo MJ, Moreno LA, Gonzalez-Gross M, Warnberg J, Gutierrez A; Grupo AVENA. [Low level of physical fitness in Spanish adolescents. Relevance for future cardiovascular health (AVENA study)]. Rev Esp Cardiol. 2005 Aug;58(8):898-909. Spanish.
PubMed 16053823Ortega FB, Ruiz JR, Hurtig-Wennlof A, Sjostrom M. [Physically active adolescents are more likely to have a healthier cardiovascular fitness level independently of their adiposity status. The European youth heart study]. Rev Esp Cardiol. 2008 Feb;61(2):123-9. Spanish.
PubMed 18364180Ortega FB, Ruiz JR, Castillo MJ, Sjostrom M. Physical fitness in childhood and adolescence: a powerful marker of health. Int J Obes (Lond). 2008 Jan;32(1):1-11. doi: 10.1038/sj.ijo.0803774. Epub 2007 Dec 4.
PubMed 18043605Ruiz JR, Castro-Pinero J, Artero EG, Ortega FB, Sjostrom M, Suni J, Castillo MJ. Predictive validity of health-related fitness in youth: a systematic review. Br J Sports Med. 2009 Dec;43(12):909-23. doi: 10.1136/bjsm.2008.056499. Epub 2009 Jan 21.
PubMed 19158130Ortega FB, Artero EG, Ruiz JR, Vicente-Rodriguez G, Bergman P, Hagstromer M, Ottevaere C, Nagy E, Konsta O, Rey-Lopez JP, Polito A, Dietrich S, Plada M, Beghin L, Manios Y, Sjostrom M, Castillo MJ; HELENA Study Group. Reliability of health-related physical fitness tests in European adolescents. The HELENA Study. Int J Obes (Lond). 2008 Nov;32 Suppl 5:S49-57. doi: 10.1038/ijo.2008.183.
PubMed 19011654Ortega FB, Artero EG, Ruiz JR, Espana-Romero V, Jimenez-Pavon D, Vicente-Rodriguez G, Moreno LA, Manios Y, Beghin L, Ottevaere C, Ciarapica D, Sarri K, Dietrich S, Blair SN, Kersting M, Molnar D, Gonzalez-Gross M, Gutierrez A, Sjostrom M, Castillo MJ; HELENA study. Physical fitness levels among European adolescents: the HELENA study. Br J Sports Med. 2011 Jan;45(1):20-9. doi: 10.1136/bjsm.2009.062679. Epub 2009 Aug 20.
PubMed 19700434Ardoy DN, Fernandez-Rodriguez JM, Chillon P, Artero EG, Espana-Romero V, Jimenez-Pavon D, Ruiz JR, Guirado-Escamez C, Castillo MJ, Ortega FB. [Physical fitness enhancement through education, EDUFIT study: background, design, methodology and dropout analysis]. Rev Esp Salud Publica. 2010 Mar-Apr;84(2):151-68. doi: 10.1590/s1135-57272010000200004. Spanish.
PubMed 20571717
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Physical Education Program Focused on Improving Physical Fitness in Adolescents Aged 12-14 Years
- ClinicalTrials.gov ID
- NCT01098968
- Acronym / sponsor ID
- EDUFIT / EDUFIT
- Conditions
- Physical Fitness, Body Composition, Lipid Metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Jun 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 5 Apr 2010 (estimated)
- 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.
EDUFIT is a group-Randomized Controlled Trial specifically designed to enhance physical fitness and other health-related factors in a school setting in adolescents.
Detailed description
Physical fitness is a powerful marker of cardiovascular health already at early stages in life. To promote physical fitness enhancement from the school is therefore needed and this is the main aim of the EDUFIT study (EDUcation for FITness).
The participants were randomly allocated to control group (CG), experimental group 1 (EG1) and experimental group 2 (EG2). The CG received 2 physical education sessions/week, the EG1 received 4 physical education sessions/week (volume increased) and the EG2 received 4 physical education sessions/week of high intensity (volume+intensity increased). Several health-related parameters were assessed before and after a 16-weeks intervention: physical fitness (primary outcome), body composition (secondary), and lipid-metabolic profile, ventilatory parameters, blood pressure, and cognitive and academic performance (tertiary outcomes).
The hypothesis of the EDUFIT project was that to double the number of physical education classes will improve physical fitness in adolescents. The confirmation of the hypothesis could have important public health implications.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal PE | No intervention | –2 Physical Education sessions / week |
| PE Volume | Experimental | Behavioral: Physical activity program4 Physical Education sessions/week (increased volume) |
| PE Volume + Intensity | Experimental | Behavioral: Physical activity program4 Physical Education sessions/week of high intensity (increased volume and intensity) |
Who may qualify
- Ages
- 12 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Adolescents enrolled in the Spanish Educational System, free of any muscle-skeletal problem not allowing take part in Physical Education lessons or fitness testing.
Key exclusion criteria (4 listed)
- Clinical diagnosis of diabetes
- Pregnancy
- Drugs/alcohol abuse
- In general, any chronic disease that does not permit the person to perform exercise and physical education lessons.
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 |
|---|---|---|
| Physical activity programSchool intervention program specifically designed to increase health-related physical fitness | Behavioural | PE Volume, PE Volume + Intensity |
Primary outcome
Health-related physical fitness
Time frame: 4 months
Cardiorespiratory fitness; musculoskeletal fitness; motor fitness.
1 secondary outcome
Cardiovascular disease risk factors
Time frame: 4 months
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 8 Sep 2011.
- Background: PubMed 16053823Ortega FB, Ruiz JR, Castillo MJ, Moreno LA, Gonzalez-Gross M, Warnberg J, Gutierrez A; Grupo AVENA. [Low level of physical fitness in Spanish adolescents. Relevance for future cardiovascular health (AVENA study)]. Rev Esp Cardiol. 2005 Aug;58(8):898-909. Spanish.
- Background: PubMed 18364180Ortega FB, Ruiz JR, Hurtig-Wennlof A, Sjostrom M. [Physically active adolescents are more likely to have a healthier cardiovascular fitness level independently of their adiposity status. The European youth heart study]. Rev Esp Cardiol. 2008 Feb;61(2):123-9. Spanish.
- Background: PubMed 18043605Ortega FB, Ruiz JR, Castillo MJ, Sjostrom M. Physical fitness in childhood and adolescence: a powerful marker of health. Int J Obes (Lond). 2008 Jan;32(1):1-11. doi: 10.1038/sj.ijo.0803774. Epub 2007 Dec 4.
- Background: PubMed 19158130Ruiz JR, Castro-Pinero J, Artero EG, Ortega FB, Sjostrom M, Suni J, Castillo MJ. Predictive validity of health-related fitness in youth: a systematic review. Br J Sports Med. 2009 Dec;43(12):909-23. doi: 10.1136/bjsm.2008.056499. Epub 2009 Jan 21.
- Background: PubMed 19011654Ortega FB, Artero EG, Ruiz JR, Vicente-Rodriguez G, Bergman P, Hagstromer M, Ottevaere C, Nagy E, Konsta O, Rey-Lopez JP, Polito A, Dietrich S, Plada M, Beghin L, Manios Y, Sjostrom M, Castillo MJ; HELENA Study Group. Reliability of health-related physical fitness tests in European adolescents. The HELENA Study. Int J Obes (Lond). 2008 Nov;32 Suppl 5:S49-57. doi: 10.1038/ijo.2008.183.
- Background: PubMed 19700434Ortega FB, Artero EG, Ruiz JR, Espana-Romero V, Jimenez-Pavon D, Vicente-Rodriguez G, Moreno LA, Manios Y, Beghin L, Ottevaere C, Ciarapica D, Sarri K, Dietrich S, Blair SN, Kersting M, Molnar D, Gonzalez-Gross M, Gutierrez A, Sjostrom M, Castillo MJ; HELENA study. Physical fitness levels among European adolescents: the HELENA study. Br J Sports Med. 2011 Jan;45(1):20-9. doi: 10.1136/bjsm.2009.062679. Epub 2009 Aug 20.
- Results publication: PubMed 20571717Ardoy DN, Fernandez-Rodriguez JM, Chillon P, Artero EG, Espana-Romero V, Jimenez-Pavon D, Ruiz JR, Guirado-Escamez C, Castillo MJ, Ortega FB. [Physical fitness enhancement through education, EDUFIT study: background, design, methodology and dropout analysis]. Rev Esp Salud Publica. 2010 Mar-Apr;84(2):151-68. doi: 10.1590/s1135-57272010000200004. Spanish.
- Official website of the HELENA Study, an European-funded project in which this research group is actively involvedLink provided by the sponsor.
- Official website of the EFFECTS-262 Research Group (University of Granada, Spain)Link provided by the sponsor.
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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.
Francisco B Ortega Porcel, PhD principal investigator
University of Granada (Spain)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity program in people with Physical Fitness and Body Composition, run by Universidad de Granada at 2 sites in Spain.
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 1 inclusion and 4 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 8 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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?
Health-related physical fitness (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01098968, which also lists 7 linked publications.
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 8 Sep 2011; AzTrials last refreshed its copy on 2 Nov 2026.