- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01098968
Education and Fitness: EDUFIT Study (EDUFIT)
Effects of a Physical Education Program Focused on Improving Physical Fitness in Adolescents Aged 12-14 Years
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Granada, Spain, 18071
- University of Granada
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Murcia
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Alcantarilla, Murcia, Spain, 30820
- IES Alcántara (Consejería de Educación, Formación y Empleo de la Región de Murcia)
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adolescents enrolled in the Spanish Educational System, free of any muscle-skeletal problem not allowing take part in Physical Education lessons or fitness testing.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Normal PE
2 Physical Education sessions / week
|
|
Experimental: PE Volume
4 Physical Education sessions/week (increased volume)
|
School intervention program specifically designed to increase health-related physical fitness
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Experimental: PE Volume + Intensity
4 Physical Education sessions/week of high intensity (increased volume and intensity)
|
School intervention program specifically designed to increase health-related physical fitness
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health-related physical fitness
Time Frame: 4 months
|
Cardiorespiratory fitness; musculoskeletal fitness; motor fitness.
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4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiovascular disease risk factors
Time Frame: 4 months
|
Body composition; lipid-metabolic profile; blood pressure; ventilatory parameters.
|
4 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Francisco B Ortega Porcel, PhD, University of Granada (Spain)
Publications and helpful links
General 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.
- Ortega 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.
- Ortega 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.
- Ruiz 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.
- Ortega 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.
- Ortega 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.
- Ardoy 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.
Study record dates
Study Major Dates
Study Start
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
Other Study ID Numbers
- EDUFIT
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