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

25 mai 2022 mis à jour par: University Hospital, Clermont-Ferrand

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

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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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).

Type d'étude

Interventionnel

Inscription (Réel)

75

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

      • Clermont-Ferrand, France
        • CHU clermont-ferrand

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

8 ans à 11 ans (Enfant)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Bike desks in classroom
All participants receive the same intervention: the use of bike desks during school.
Children will use bike desks for 13 weeks during school time

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Students cognitive abilities
Délai: Week 0
Time to complete the Trail Making Test part A and B (seconds)
Week 0
Students cognitive abilities
Délai: 7 weeks
Time to complete the Trail Making Test part A and B (seconds)
7 weeks
Students cognitive abilities
Délai: 13 weeks
Time to complete the Trail Making Test part A and B (seconds)
13 weeks

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Weight
Délai: Week 0
Weight (kg) will be assessed by bioimpedance analysis with Tanita MC-780 (Tanita Corp., Tokyo, Japan)
Week 0
Body composition (body mass index)
Délai: 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
Week 0
Body composition (body fat mass)
Délai: Week 0
Body fat mass (%) will be assessed by bioimpedance analysis with Tanita MC-780 (Tanita Corp., Tokyo, Japan)
Week 0
Weight
Délai: 7 weeks
Weight (kg) will be assessed by bioimpedance analysis with Tanita MC-780 (Tanita Corp., Tokyo, Japan)
7 weeks
Body composition (body mass index)
Délai: 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
7 weeks
Body composition (body fat mass)
Délai: 7 weeks
Body fat mass (%) will be assessed by bioimpedance analysis with Tanita MC-780 (Tanita Corp., Tokyo, Japan)
7 weeks
Weight
Délai: 13 weeks
Weight (kg) will be assessed by bioimpedance analysis with Tanita MC-780 (Tanita Corp., Tokyo, Japan)
13 weeks
Body composition (body mass index)
Délai: 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
13 weeks
Body composition (body fat mass)
Délai: 13 weeks
Body fat mass (%) will be assessed by bioimpedance analysis with Tanita MC-780 (Tanita Corp., Tokyo, Japan)
13 weeks
Physical fitness (cardio-respiratory capacity)
Délai: Week 0
Cardio-respiratory capacity will be assessed with 20 m shuttle test (ml.mn.kg-1)
Week 0
Physical fitness (cardio-respiratory capacity)
Délai: 7 weeks
Cardio-respiratory capacity will be assessed with 20 m shuttle test (ml.mn.kg-1)
7 weeks
Physical fitness (cardio-respiratory capacity)
Délai: 13 weeks
Cardio-respiratory capacity will be assessed with 20 m shuttle test (ml.mn.kg-1)
13 weeks
Physical fitness (muscular strength)
Délai: Week 0
Muscular strength will be assessed with Standing Broad Jump test (cm), Countermovement Jump test (cm) and Throw Medicine Ball test (cm)
Week 0
Physical fitness (upper limbs muscular strength)
Délai: Week 0
Muscular strength will be assessed with Handgrip test (kg)
Week 0
Physical fitness (muscular strength)
Délai: 7 weeks
Muscular strength will be assessed with Standing Broad Jump test (cm), Countermovement Jump test (cm) and Throw Medicine Ball test (cm)
7 weeks
Physical fitness (upper limbs muscular strength)
Délai: 7 weeks
Muscular strength will be assessed with Handgrip test (kg)
7 weeks
Physical fitness (muscular strength)
Délai: 13 weeks
Muscular strength will be assessed with Standing Broad Jump test (cm), Countermovement Jump test (cm) and Throw Medicine Ball test (cm)
13 weeks
Physical fitness (upper limbs muscular strength)
Délai: 13 weeks
Muscular strength will be assessed with Handgrip test (kg)
13 weeks
Physical fitness (motor skills)
Délai: Week 0
Motor skills will be assessed with the time to complete an obstacle course (seconds)
Week 0
Physical fitness (motor skills)
Délai: 7 weeks
Motor skills will be assessed with the time to complete an obstacle course (seconds)
7 weeks
Physical fitness (motor skills)
Délai: 13 weeks
Motor skills will be assessed with the time to complete an obstacle course (seconds)
13 weeks
Implicit and explicit attraction to physical activity
Délai: Week 0
Implicit and explicit attraction to physical activity will be assessed with Activity Preference Assessment (APA) computer test
Week 0
Implicit and explicit attraction to physical activity
Délai: 7 weeks
Implicit and explicit attraction to physical activity will be assessed with Activity Preference Assessment (APA) computer test
7 weeks
Implicit and explicit attraction to physical activity
Délai: 13 weeks
Implicit and explicit attraction to physical activity will be assessed with Activity Preference Assessment (APA) computer test
13 weeks
Teachers' perceptions of students' well-being
Délai: 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.
Week 0
Teachers' perceptions of students' well-being
Délai: 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.
7 weeks
Teachers' perceptions of students' well-being
Délai: 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.
13 weeks
Students and teachers' perceived well-being
Délai: 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.
7 weeks
Students and teachers' perceived well-being
Délai: 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.
13 weeks
Classroom climate/atmosphere
Délai: 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.
7 weeks
Classroom climate/atmosphere
Délai: 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.
13 weeks
Possible factors of failure of the strategy
Délai: 13 weeks
Questionnaire: socioeconomical level of parents, reason for refusal to participate , parents feeling, students feeling, teachers feeling. Higher scores mean a better outcome.
13 weeks

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

12 avril 2021

Achèvement primaire (Réel)

25 juin 2021

Achèvement de l'étude (Réel)

25 juin 2021

Dates d'inscription aux études

Première soumission

14 avril 2021

Première soumission répondant aux critères de contrôle qualité

5 mai 2021

Première publication (Réel)

11 mai 2021

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

26 mai 2022

Dernière mise à jour soumise répondant aux critères de contrôle qualité

25 mai 2022

Dernière vérification

1 mai 2022

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • RBHP 2021 DUCLOS
  • 2021-A00114-37 (Autre identifiant: 2021-A00114-37)

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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