Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

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

25 de mayo de 2022 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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).

Tipo de estudio

Intervencionista

Inscripción (Actual)

75

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Clermont-Ferrand, Francia
        • CHU clermont-ferrand

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

8 años a 11 años (Niño)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Students cognitive abilities
Periodo de tiempo: Week 0
Time to complete the Trail Making Test part A and B (seconds)
Week 0
Students cognitive abilities
Periodo de tiempo: 7 weeks
Time to complete the Trail Making Test part A and B (seconds)
7 weeks
Students cognitive abilities
Periodo de tiempo: 13 weeks
Time to complete the Trail Making Test part A and B (seconds)
13 weeks

Medidas de resultado secundarias

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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

12 de abril de 2021

Finalización primaria (Actual)

25 de junio de 2021

Finalización del estudio (Actual)

25 de junio de 2021

Fechas de registro del estudio

Enviado por primera vez

14 de abril de 2021

Primero enviado que cumplió con los criterios de control de calidad

5 de mayo de 2021

Publicado por primera vez (Actual)

11 de mayo de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

26 de mayo de 2022

Última actualización enviada que cumplió con los criterios de control de calidad

25 de mayo de 2022

Última verificación

1 de mayo de 2022

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • RBHP 2021 DUCLOS
  • 2021-A00114-37 (Otro identificador: 2021-A00114-37)

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Suscribir