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

25. května 2022 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Detailní popis

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).

Typ studie

Intervenční

Zápis (Aktuální)

75

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

      • Clermont-Ferrand, Francie
        • Chu Clermont-Ferrand

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

8 let až 11 let (Dítě)

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: N/A
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Students cognitive abilities
Časové okno: Week 0
Time to complete the Trail Making Test part A and B (seconds)
Week 0
Students cognitive abilities
Časové okno: 7 weeks
Time to complete the Trail Making Test part A and B (seconds)
7 weeks
Students cognitive abilities
Časové okno: 13 weeks
Time to complete the Trail Making Test part A and B (seconds)
13 weeks

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Weight
Časové okno: 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)
Časové okno: 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)
Časové okno: Week 0
Body fat mass (%) will be assessed by bioimpedance analysis with Tanita MC-780 (Tanita Corp., Tokyo, Japan)
Week 0
Weight
Časové okno: 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)
Časové okno: 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)
Časové okno: 7 weeks
Body fat mass (%) will be assessed by bioimpedance analysis with Tanita MC-780 (Tanita Corp., Tokyo, Japan)
7 weeks
Weight
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: Week 0
Cardio-respiratory capacity will be assessed with 20 m shuttle test (ml.mn.kg-1)
Week 0
Physical fitness (cardio-respiratory capacity)
Časové okno: 7 weeks
Cardio-respiratory capacity will be assessed with 20 m shuttle test (ml.mn.kg-1)
7 weeks
Physical fitness (cardio-respiratory capacity)
Časové okno: 13 weeks
Cardio-respiratory capacity will be assessed with 20 m shuttle test (ml.mn.kg-1)
13 weeks
Physical fitness (muscular strength)
Časové okno: 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)
Časové okno: Week 0
Muscular strength will be assessed with Handgrip test (kg)
Week 0
Physical fitness (muscular strength)
Časové okno: 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)
Časové okno: 7 weeks
Muscular strength will be assessed with Handgrip test (kg)
7 weeks
Physical fitness (muscular strength)
Časové okno: 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)
Časové okno: 13 weeks
Muscular strength will be assessed with Handgrip test (kg)
13 weeks
Physical fitness (motor skills)
Časové okno: Week 0
Motor skills will be assessed with the time to complete an obstacle course (seconds)
Week 0
Physical fitness (motor skills)
Časové okno: 7 weeks
Motor skills will be assessed with the time to complete an obstacle course (seconds)
7 weeks
Physical fitness (motor skills)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

12. dubna 2021

Primární dokončení (Aktuální)

25. června 2021

Dokončení studie (Aktuální)

25. června 2021

Termíny zápisu do studia

První předloženo

14. dubna 2021

První předloženo, které splnilo kritéria kontroly kvality

5. května 2021

První zveřejněno (Aktuální)

11. května 2021

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

26. května 2022

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

25. května 2022

Naposledy ověřeno

1. května 2022

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • RBHP 2021 DUCLOS
  • 2021-A00114-37 (Jiný identifikátor: 2021-A00114-37)

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