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

25 maja 2022 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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 studiów

Interwencyjne

Zapisy (Rzeczywisty)

75

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Francja
      • Clermont-Ferrand, Francja
        • Chu Clermont-Ferrand

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

8 lat do 11 lat (Dziecko)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Bike desks in classroom
All participants receive the same intervention: the use of bike desks during school.
Inny: bike desks in the classroom
Children will use bike desks for 13 weeks during school time

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Students cognitive abilities
Ramy czasowe: Week 0
Time to complete the Trail Making Test part A and B (seconds)
Week 0
Students cognitive abilities
Ramy czasowe: 7 weeks
Time to complete the Trail Making Test part A and B (seconds)
7 weeks
Students cognitive abilities
Ramy czasowe: 13 weeks
Time to complete the Trail Making Test part A and B (seconds)
13 weeks

Miary wyników drugorzędnych

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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University Hospital, Clermont-Ferrand

Współpracownicy

Université d'Auvergne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

12 kwietnia 2021

Zakończenie podstawowe (Rzeczywisty)

25 czerwca 2021

Ukończenie studiów (Rzeczywisty)

25 czerwca 2021

Daty rejestracji na studia

Pierwszy przesłany

14 kwietnia 2021

Pierwszy przesłany, który spełnia kryteria kontroli jakości

5 maja 2021

Pierwszy wysłany (Rzeczywisty)

11 maja 2021

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

26 maja 2022

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

25 maja 2022

Ostatnia weryfikacja

1 maja 2022

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Inne numery identyfikacyjne badania

  • RBHP 2021 DUCLOS
  • 2021-A00114-37 (Inny identyfikator: 2021-A00114-37)

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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