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Physical ActivityNCT05891054

Effects of the Inclusion of Physical Activity in Secondary School Academic Classes: the ACTIVE CLASS Study

A study testing Active breaks and Physically active learning in people with Physical Activity and Adolescents, run by University of Extremadura at 2 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Study based on the inclusion of physical activity in the secondary education classroom through active breaks and physically active learning, aimed at testing its effects on the improvement of physical activity levels, sedentary time, educational indicators, cognition and physical and psychological health markers. Read more about this study

Who is it for?
Ages 11 to 14 yearsHealthy volunteers can take part
Conditions the study is for
Physical Activity, Adolescents, Cognition
What is being tested?
Active breaks and Physically active learning
Could I receive a placebo?
No, everyone receives an active treatment
How many people
292 participants
Where
2 sitesSpain
Study dates
9 Jan 2023to 21 Jun 2023
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 11 to 14 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Adolescents who are studying 7th or 8th grade
  • Adolescents with the informed consent signed by family/tutor
  • Schools with at least 60 students enrolled in 7th and/or 8th grade
  • Schools belonging to the regions of Cáceres and Cádiz

Who cannot join

  • Adolescents who have a physical disability or health condition that could limit physical activity levels
  • Schools participating in any other physical activity or health promotion program

Trial locations and contacts

2 sites in 1 country.

Spain2 sites

  • University of Extremadura

    Cáceres, 10003

  • University of Cádiz

    Puerto Real, Cádiz, 11510

Other trials in Spain

About this study

Official title: Effects of the Inclusion of Physical Activity in Secondary School Academic Classes on Educational Indicators and Health Markers: the ACTIVE CLASS Study

Study based on the inclusion of physical activity in the secondary education classroom through active breaks and physically active learning, aimed at testing its effects on the improvement of physical activity levels, sedentary time, educational indicators, cognition and physical and psychological health markers.

Read the detailed description

The ACTIVE CLASS is a randomized controlled study coordinated by fully qualified researchers in the physical activity and sport sciences from two universities [University of Cadiz (UCA) and University of Extremadura (UEX), Spain]. This study is aimed at 7th and 8th grade students (11-13 years old), belonging to 6 schools in Spain (3 schools in Cadiz and 3 schools in Caceres). One school from each study region will be randomly assigned to one of the three intervention groups:

(i) Active breaks intervention: there will be 2 active breaks per day, 5 days a week of moderate-vigorous physical activity with a duration of 5 minutes.

(ii) Physically active learning intervention: Once a week, moderate-vigorous physical activity will be included in the academic lessons of the mathematics subject.

(iii) Control group.

The interventions will have a duration of 16 weeks. The different outcome measures (physical activity and sedentary behavior, health-related physical fitness, psychological health, academic indicators, cognition, motivational variables, dietary patterns, sociodemographic characteristics and qualitative information) will be evaluated at 3 time points:

  1. Pre-intervention
  2. Post-intervention
  3. Retention measure (this measure will be conducted four weeks after the intervention to analyze the sustainability of the intervention program)

All measures will be assessed at each time point with the exception of qualitative information which will be assessed only in the post-intervention measure.

At the end of the intervention the researchers will determine the changes of the main outcome variables. Likewise, the main hypotheses raised will be:

  1. A physically active learning intervention and active breaks will result in improved physical activity levels and decreased sedentary time.
  2. A physically active learning intervention and active breaks will produce improvements in markers of physical and psychological health.
  3. The inclusion of physical activity in academic classes will result in improved academic indicators and cognitive markers.
  4. A physically active learning intervention and active breaks will produce improvements on motivational variables in academic classes.
Being tested
Active breaks, Physically active learning
Keywords
Active break, Physically active learning, Academic indicators, Motivational variables, Sedentary time
Medical subject headings
Motor Activity, Sedentary Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Active breaksBehavioural

    Two active breaks are taken daily in a predetermined time slot. The development of each break is done through access to a specific digital platform where students follow the instructions of an avatar, which is in charge of guiding the realization of the active break. Each active rest involves a total of 4 minutes of activity, in which two sets of 20 seconds of work and 10 seconds of rest of four different exercises are performed, ending with a brief return to calm consisting of two deep breaths. The activities selected for each of the active breaks include aerobic and strengthening activities of moderate and vigorous intensity.

  • Physically active learningBehavioural

    The physically active learning is carried out once a week for 1 hour outside the classroom, where physical activity (through movement, jumping, strengthening exercises, throwing, etc.) is incorporated into academic mathematics classes.

    The mathematics teachers (with the support of the research team) are in charge of teaching the physically active classes. Prior to the development of each class, the research team, together with the mathematics teachers involved, meet and design the class according to the contents to be addressed.

Study groups in NCT05891054
Study groupRoleWhat they receive
Active breaksExperimentalActive breaks consist of short breaks during academic classes other than physical education that include moderate to vigorous physical activity, usually unrelated to curricular content. In this type of intervention, 2 active breaks are taken daily in a predetermined time slot. The development of each break is done through access to a specific digital platform where students follow the instructions of an avatar, which is in charge of guiding the realization of the active break. Each active rest involves a total of 4 minutes of activity, in which two sets of 20 seconds of work and 10 seconds of rest of four different exercises are performed, ending with a brief return to calm consisting of two deep breaths. The activities selected for each of the active breaks include aerobic and strengthening activities of moderate and vigorous intensity.
Receives: Behavioral: Active breaks
Physically active learningExperimentalPhysically active learning consists of the incorporation of physical activity (usually of moderate-vigorous intensity) into the educational content taught in academic lessons that do not refer to physical education. This type of intervention is carried out once a week for 1 hour outside the classroom, where physical activity (through movement, jumping, strengthening exercises, throwing, etc.) is incorporated into academic mathematics classes. The mathematics teachers (with the support of the research team) are in charge of teaching the physically active classes. Prior to the development of each class, the research team, together with the mathematics teachers involved, meet and design the class according to the contents to be addressed.
Receives: Behavioral: Physically active learning
Control GroupNo interventionThe control group will receive the usual academic classes without any methodological modification during the intervention period.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Physical activity and sedentary time

    Physical activity and sedentary time will be measured through accelerometry (Actigraph GT3X+, Inc., Pensacola, FL, USA).

    Measured: 6 months

Secondary outcomes (20)

  1. Cardiorespiratory capacity

    The 20-metre shuttle run test will be used to assess cardiorespiratory fitness. Participants will run the 20-metre distance to the rhythm of a recording. The initial speed is 8.5 km/h and will be increased by 0.5 km/h per section. The race will end when the participant stops due to fatigue or when he/she fails to cross the marked lines to the rhythm of the acoustic signals on two consecutive occasions. The last stage or half stage completed by the competitor will be scored.

    Measured: 6 months

  2. Musculoskeletal capacity of upper body

    The hand grip test will be used to assess musculoskeletal capacity of upper body. The test shall be performed twice with each hand alternately. The maximum score of each hand in kilograms shall be recorded and the mean value between them shall be calculated.

    Measured: 6 months

  3. Musculoskeletal capacity of lower body

    Standing broad jump shall be used to assess the musculoskeletal capacity of the lower limbs. The participant shall stand behind a line with feet shoulder width apart. The participant is then asked to jump forward as far as possible with both feet. If he/she rests his/her hands or lifts his/her feet off the ground when landing, the test is invalid. The test shall be performed twice, and the best score recorded in centimetres.

    Measured: 6 months

  4. Body mass index

    Weight and height will be combined to report BMI in kg/m^2. In both cases the measurement shall be performed twice and the mean shall be recorded.

    Measured: 6 months

  5. Body composition

    Waist circumference shall be measured as a body composition variable with a non-elastic tape placed in the frontal plane at the midpoint between the upper iliac spine and the costal border at the mid-axillary line. The measurement shall be taken twice and the mean of the two measurements shall be recorded.

    Measured: 6 months

  6. Subjective physical fitness

    The International Fitness Scale will be used for the assessment of subjective physical fitness. Participants will be asked to rate each of the fitness components on a 5-point Likert-type scale ranging from: "very poor" (1); "poor" (2); "fair" (3); "good" (4) and "very good".

    Measured: 6 months

  7. Health status

    The EuroQol five dimensions three levels will be used to assessment of health status (EQ-5D-3L).This questionnaire is composed of the dimensions of: (i) mobility; (ii) self-care; (iii) usual activities; (iv) pain/discomfort and (v) anxiety/depression. The three levels that participants should mark a Likert-type scale correspond to (i) no problem; (ii) some problems; (iii) many problem.

    Measured: 6 months

  8. Self-perceived health

    Self-perceived health will be measured through the classic self-reported health item, where participants will have to classify their health among the following options: "excellent" (5); "very good" (4); "good" (3); "fair" (2) and "poor" (1).

    Measured: 6 months

  9. School engagement

    The engagement scale (UWES-S-9) will be used to evaluate school engagement. The UWES-S-9 is composed of nine items that reflect the three dimensions of engagement: (i) vigor; (ii) absorption; and (iii) dedication, each dimension is represented by three items that will be evaluated through a Likert-type scale, ranging from "never" (0 points) to "always" (6 points).

    Measured: 6 months

  10. Learning perception

    Learning perception in mathematics and in general studies will be assessed by means of a questionnaire consisting of eight items. Items 1- 4 will assess the "perceived learning" dimension and items 5-8 will measure the "satisfaction with learning" dimension. All items will be scored according to a five-point Likert scale, where "1" is (strongly disagree) and "5" is (strongly agree).

    Measured: 6 months

  11. Academic performance

    Academic performance will be evaluated through the marks reported by the schools before and after the intervention.

    Measured: 6 months

  12. Time on task

    Time on task will be assessed by direct observation in mathematics classes or in the classes were the active breaks take place, and in the consecutive class one hour later. Each researcher will assess a total of six students per assessment, where they have 15 seconds per subject to observe, identify the type of behaviour and record it on a worksheet. The researcher will repeat this process for the entire hour. Behaviours will be classified as 'on-task' and 'off-task'. The latter shall be divided into (i) "off-task-motor"; (ii) "off-task-noise"; (iii) "off-task-passive". The percentage of time students spend on each of the behaviours will be recorded.

    Measured: 6 months

  13. Inhibition

    Inhibition will be evaluated through the Flanker task protocol, part of the NIH Examiner programme. This is a computerised programme where the subject answers the tests individually. The algorithm provided by the program, ranging from 0 to 10, which includes accuracy and reaction time, will be recorded.

    Measured: 6 months

  14. Cognitive flexibility

    Cognitive flexibility will be evaluated through the Shifting task protocol, part of the NIH Examiner programme. This is a computerised programme where the subject answers the tests individually. The algorithm provided by the program, ranging from 0 to 10, which includes accuracy and reaction time, will be recorded.

    Measured: 6 months

  15. Working memory

    Working memory will be evaluated through the N-Back protocol, part of the NIH Examiner programme. This is a computerised programme where the subject answers the tests individually. The algorithm provided by the program, ranging from 0 to 10, which includes accuracy and reaction time, will be recorded.

    Measured: 6 months

  16. Novelty

    Novelty will be assessed through the Novelty Need Satisfaction Scale. Five of the 19 questions that make up the original scale will be selected and participants will be asked to answer them on a Likert-type scale where 1 = "strongly disagree" and 5 = "strongly agree".

    Measured: 6 months

  17. Enjoyment and boredom

    Enjoyment and boredom will be assessed using the Spanish version of The Sport Satisfaction Instrument. This scale is composed of eight items. Participants will have to rate their degree of agreement with the items referring to fun or boredom on a five-point Likert-type scale, ranging from 1 (strongly disagree) to 5 (strongly agree).

    Measured: 6 months

  18. Dietary patterns

    Adherence to the Mediterranean diet will be measured using the updated version 2.0 of the KIDMED questionnaire.

    Measured: 6 months

  19. Sociodemographic characteristics

    Sociodemographic characteristics will be measured through the Spanish-adapted version III of The Family Affluence Scale.

    Measured: 6 months

  20. Teachers' and students' perception about the suitability and the development of physically active classes and active breaks

    perception about the suitability and the development of physically active classes and active breaks (perceptions, barriers, points to improve, strengths...) a semi-structured interview will be conducted with the teachers involved in the intervention. Additionally, and for the same purpose, a discussion group will be developed for each of the proposed interventions with a subsample of students.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2023
  2. Study start9 Jan 2023
  3. Primary completion21 Jun 2023
  4. Study completion21 Jun 2023

Resources

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
292 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05891054
Sponsor's protocol ID
PID2019-104023RA-I00
Status last verified
Jun 2023
First submitted
11 May 2023
Last updated
27 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gonzalez-Perez M, Camiletti-Moiron D, Ruiz-Hermosa A, Martin-Acosta F, Grao-Cruces A, Sanchez-Oliva D. Effect of physically active learning on physical activity levels in secondary school students: The ACTIVE CLASS Study. BMC Public Health. 2026 Mar 7;26(1):1218. doi: 10.1186/s12889-026-26814-6.

    PubMed 41795067

  • Grao-Cruces A, Martin-Acosta F, Vaquero-Solis M, Ruiz-Hermosa A, Camiletti-Moiron D, Sanchez-Oliva D. Fitness, Weight Status and Executive Functions in Adolescents: A Cluster Analysis. Scand J Med Sci Sports. 2025 Aug;35(8):e70098. doi: 10.1111/sms.70098.

    PubMed 40719569

  • Gonzalez-Perez M, Sanchez-Oliva D, Grao-Cruces A, Cano-Canada E, Martin-Acosta F, Munoz-Gonzalez R, Bandera-Campos FJ, Ruiz-Hermosa A, Vaquero-Solis M, Padilla-Moledo C, Conde-Caveda J, Segura-Jimenez V, Gonzalez-Ponce I, Garcia-Calvo T, Castro-Pinero J, Camiletti-Moiron D. Effects of the inclusion of physical activity in secondary education academic classes on educational indicators and health markers: rationale and methods of the ACTIVE CLASS study. Front Public Health. 2024 Jan 5;11:1329245. doi: 10.3389/fpubh.2023.1329245. eCollection 2023.

    PubMed 38249387

Questions about this trial

What is this clinical trial studying?

A study testing Active breaks and Physically active learning in people with Physical Activity and Adolescents, run by University of Extremadura 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 4 inclusion and 2 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 27 Jun 2025. 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?

Physical activity and sedentary time (time frame: 6 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 NCT05891054, which also lists 3 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 27 Jun 2025.

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