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Completed

NCT Number: NCT04880759

Pilot Study of Active Desk in Primary School : Effects on Cognitive Capacities, Physical Capacities and Well-being

Physical activity (PA) is insufficient in children with three quarters of them who do not meet the WHO's recommendations. Physical inactivity is growing during adolescence; in part due to the time spend in sedentary behaviors at school. The recent literature is highlighting the importance of physical activity on academic achievement, physical fitness and academic achievement in children. In addition, deleterious effects of sedentary behaviors have been demonstrated. At school, many strategies have been settled to break the prolonged sitting time. The use of workstations is one of them and allows to reduce sedentary time at school and increases physical activity without interrupting class. Active workstations like bike desks have demonstrated their effectiveness on physical activity but their effects have not been evaluated in primary school in France. In addition, few studies have evaluated the effects of bike desk use on the child's cognitive abilities.

The main objective of this project is to measure the variations linked to the use of bike desks (desk with pedals) for an average of 1h45mn per week (30min 3 to 4 times per week) for 13 weeks during school time in primary school pupils (aged 8 to 11 years) on the cognitive abilities (mental flexibility, working memory and inhibition) of children.

Our hypothesis is that the use of the bike desk for 1h45 per week will induce an increase in the attention and cognitive capacities (mental flexibility, working memory and inhibition) of the children. Other improvements that should be identified are the child's body composition, the classroom climate and the well-being of pupils and teachers. The children's physical capacities could also be increased, beyond what is expected given the normal evolution during the year.

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Key information

Conditions

Cognition Behavior Sedentary Behavior

Age range

8 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU clermont-ferrand

Clermont-Ferrand, France

About this study

Two prospective schools have given their prior agreement : Sevigne Lafaye (Vichy) and Pierre Brossolette (Riom). The use of the bike desks in the classroom is part of the school project and will start at the same time as the study. There are 4 bike-desks in each class: 3 for the children and 1 for the teacher. Students pedaling during an overall of 13 weeks (7 weeks and 6 weeks) separated of one evaluation session week (T1). During weeks with evaluation sessions, children will not use bike desk. All children will therefore use the bike desks but only those who have signed the consent form.

An information meeting will be proposed in each school (visit 1). Then, subjects will have a pre-inclusion visit during a medical consultation where the eligibility criteria to participate in this study will be checked (visit 2). The children who have given their consent will have to participate in different evaluation sessions: baseline (T0), between to two pedaling sessions (T1) and at the end of the second session (T2). They are two parts of assessments for each session (T0, T1, T2):

  • Cognitive test and the physical activity attraction test (visits 3, 5, 7)
  • Body composition and physical capacity assessment (visits 4, 6, 8) Questionnaires will also be part of the assessment (T1 and T2).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children between 8 and 11 years old (inclusive)
  • Girls and boys
  • Children enrolled in CM1a and CM1b classes at the Pierre Brossolette school in Riom and in CM1/CM2 and CM2 classes at the Sévigné-Lafaye school in Vichy.
  • Able to provide informed consent to research participation
  • Registered in the French social security system

Exclusion criteria

  • Medical or surgical history judged by the investigator to be incompatible with the study
  • Any unstabilised chronic pathology
  • Inability to pedal
  • Inability or contraindication to physical activity
  • Subjects with cardiorespiratory and/or osteoarticular disorders that limit their ability to perform physical tests or use the cycle desks
  • Subjects with a progressive cardiovascular or neoplastic disease.
  • Subjects with a major infection in the 3 months prior to inclusion
  • Subject with chronic or acute inflammatory disease in the 3 months prior to inclusion
  • Subject diagnosed and/or treated for schizophrenia, bipolar disorder, major depression
  • Person under guardianship, curatorship or not subject to a social security scheme
  • Refusal to sign written consent to participate by the participant or a parent or guardian

Treatment and study plan

bike desks in the classroom

Other

Children will use bike desks for 13 weeks during school time

Primary outcomes

  1. Students cognitive abilities

    Time frame: Week 0

    Time to complete the Trail Making Test part A and B (seconds)

  2. Students cognitive abilities

    Time frame: 7 weeks

    Time to complete the Trail Making Test part A and B (seconds)

  3. Students cognitive abilities

    Time frame: 13 weeks

    Time to complete the Trail Making Test part A and B (seconds)

Secondary outcomes

  1. Weight

    Time frame: Week 0

    Weight (kg) will be assessed by bioimpedance analysis with Tanita MC-780 (Tanita Corp., Tokyo, Japan)

  2. Body composition (body mass index)

    Time frame: Week 0

    Body mass index (kg/m^2) will be assessed by bioimpedance analysis with Tanita MC-780 (Tanita Corp., Tokyo, Japan) by combining weight and height

  3. Body composition (body fat mass)

    Time frame: Week 0

    Body fat mass (%) will be assessed by bioimpedance analysis with Tanita MC-780 (Tanita Corp., Tokyo, Japan)

  4. Weight

    Time frame: 7 weeks

    Weight (kg) will be assessed by bioimpedance analysis with Tanita MC-780 (Tanita Corp., Tokyo, Japan)

  5. Body composition (body mass index)

    Time frame: 7 weeks

    Body mass index (kg/m^2) will be assessed by bioimpedance analysis with Tanita MC-780 (Tanita Corp., Tokyo, Japan) by combining weight and height

  6. Body composition (body fat mass)

    Time frame: 7 weeks

    Body fat mass (%) will be assessed by bioimpedance analysis with Tanita MC-780 (Tanita Corp., Tokyo, Japan)

  7. Weight

    Time frame: 13 weeks

    Weight (kg) will be assessed by bioimpedance analysis with Tanita MC-780 (Tanita Corp., Tokyo, Japan)

  8. Body composition (body mass index)

    Time frame: 13 weeks

    Body mass index (kg/m^2) will be assessed by bioimpedance analysis with Tanita MC-780 (Tanita Corp., Tokyo, Japan) by combining weight and height

  9. Body composition (body fat mass)

    Time frame: 13 weeks

    Body fat mass (%) will be assessed by bioimpedance analysis with Tanita MC-780 (Tanita Corp., Tokyo, Japan)

  10. Physical fitness (cardio-respiratory capacity)

    Time frame: Week 0

    Cardio-respiratory capacity will be assessed with 20 m shuttle test (ml.mn.kg-1)

  11. Physical fitness (cardio-respiratory capacity)

    Time frame: 7 weeks

    Cardio-respiratory capacity will be assessed with 20 m shuttle test (ml.mn.kg-1)

  12. Physical fitness (cardio-respiratory capacity)

    Time frame: 13 weeks

    Cardio-respiratory capacity will be assessed with 20 m shuttle test (ml.mn.kg-1)

  13. Physical fitness (muscular strength)

    Time frame: Week 0

    Muscular strength will be assessed with Standing Broad Jump test (cm), Countermovement Jump test (cm) and Throw Medicine Ball test (cm)

  14. Physical fitness (upper limbs muscular strength)

    Time frame: Week 0

    Muscular strength will be assessed with Handgrip test (kg)

  15. Physical fitness (muscular strength)

    Time frame: 7 weeks

    Muscular strength will be assessed with Standing Broad Jump test (cm), Countermovement Jump test (cm) and Throw Medicine Ball test (cm)

  16. Physical fitness (upper limbs muscular strength)

    Time frame: 7 weeks

    Muscular strength will be assessed with Handgrip test (kg)

  17. Physical fitness (muscular strength)

    Time frame: 13 weeks

    Muscular strength will be assessed with Standing Broad Jump test (cm), Countermovement Jump test (cm) and Throw Medicine Ball test (cm)

  18. Physical fitness (upper limbs muscular strength)

    Time frame: 13 weeks

    Muscular strength will be assessed with Handgrip test (kg)

  19. Physical fitness (motor skills)

    Time frame: Week 0

    Motor skills will be assessed with the time to complete an obstacle course (seconds)

  20. Physical fitness (motor skills)

    Time frame: 7 weeks

    Motor skills will be assessed with the time to complete an obstacle course (seconds)

  21. Physical fitness (motor skills)

    Time frame: 13 weeks

    Motor skills will be assessed with the time to complete an obstacle course (seconds)

  22. Implicit and explicit attraction to physical activity

    Time frame: Week 0

    Implicit and explicit attraction to physical activity will be assessed with Activity Preference Assessment (APA) computer test

  23. Implicit and explicit attraction to physical activity

    Time frame: 7 weeks

    Implicit and explicit attraction to physical activity will be assessed with Activity Preference Assessment (APA) computer test

  24. Implicit and explicit attraction to physical activity

    Time frame: 13 weeks

    Implicit and explicit attraction to physical activity will be assessed with Activity Preference Assessment (APA) computer test

  25. Teachers' perceptions of students' well-being

    Time frame: Week 0

    Questionnaire created by the National Education. Items will be rated from 1 to 5: 1 unsatisfactory; 2 marginally satisfactory; 3 neutral; 4 satisfactory; 5 very satisfactory. Higher scores mean a better outcome.

  26. Teachers' perceptions of students' well-being

    Time frame: 7 weeks

    Questionnaire created by the National Education. Items will be rated from 1 to 5: 1 unsatisfactory; 2 marginally satisfactory; 3 neutral; 4 satisfactory; 5 very satisfactory. Higher scores mean a better outcome.

  27. Teachers' perceptions of students' well-being

    Time frame: 13 weeks

    Questionnaire created by the National Education. Items will be rated from 1 to 5: 1 unsatisfactory; 2 marginally satisfactory; 3 neutral; 4 satisfactory; 5 very satisfactory. Higher scores mean a better outcome.

  28. Students and teachers' perceived well-being

    Time frame: 7 weeks

    Questionnaire created by the National Education. Items will be rated with smiley or rating from 1 to 5: 1 unsatisfactory; 2 marginally satisfactory; 3 neutral; 4 satisfactory; 5 very satisfactory. Higher scores mean a better outcome.

  29. Students and teachers' perceived well-being

    Time frame: 13 weeks

    Questionnaire created by the National Education. Items will be rated with smiley or rating from 1 to 5: 1 unsatisfactory; 2 marginally satisfactory; 3 neutral; 4 satisfactory; 5 very satisfactory. Higher scores mean a better outcome.

  30. Classroom climate/atmosphere

    Time frame: 7 weeks

    Questionnaire created by the National Education. Items will be rated from 1 to 5: 1 unsatisfactory; 2 marginally satisfactory; 3 neutral; 4 satisfactory; 5 very satisfactory. Higher scores mean a better outcome.

  31. Classroom climate/atmosphere

    Time frame: 13 weeks

    Questionnaire created by the National Education. Items will be rated from 1 to 5: 1 unsatisfactory; 2 marginally satisfactory; 3 neutral; 4 satisfactory; 5 very satisfactory. Higher scores mean a better outcome.

  32. Possible factors of failure of the strategy

    Time frame: 13 weeks

    Questionnaire: socioeconomical level of parents, reason for refusal to participate , parents feeling, students feeling, teachers feeling. Higher scores mean a better outcome.

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Collaborators

  • Université d'Auvergne

Registry information

Official study title

Pilot Study of Active Desk in Primary School : Effects on the Attention, Cognitive Capacities, Physical Capacities, Concentration and Well-being of Student and on the Classroom Climate

Acronym: BICLASS

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 11, 2021
Registry last updated
May 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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