Clinical trial NCT04880759: Pilot Study of Active Desk in Primary School : Effects on Cognitive Capacities, Physical Capacities and Well-being
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognition
Keywords: Cycling desk
Active workstation
Sedentary Behavior
Cognition
Child health
Body composition
Physical fitness
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Université d'Auvergne
First posted: 2021-05-11
Enrollment: 75
Sex: ALL
Minimum age (years): 8
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Students cognitive abilities
timeFrame: Week 0
measure: Students cognitive abilities
timeFrame: 7 weeks
measure: Students cognitive abilities
timeFrame: 13 weeks
Secondary outcomes:
measure: Weight
timeFrame: Week 0
measure: Body composition (body mass index)
timeFrame: Week 0
measure: Body composition (body fat mass)
timeFrame: Week 0
measure: Weight
timeFrame: 7 weeks
measure: Body composition (body mass index)
timeFrame: 7 weeks
measure: Body composition (body fat mass)
timeFrame: 7 weeks
measure: Weight
timeFrame: 13 weeks
measure: Body composition (body mass index)
timeFrame: 13 weeks
measure: Body composition (body fat mass)
timeFrame: 13 weeks
measure: Physical fitness (cardio-respiratory capacity)
timeFrame: Week 0
measure: Physical fitness (cardio-respiratory capacity)
timeFrame: 7 weeks
measure: Physical fitness (cardio-respiratory capacity)
timeFrame: 13 weeks
measure: Physical fitness (muscular strength)
timeFrame: Week 0
measure: Physical fitness (upper limbs muscular strength)
timeFrame: Week 0
measure: Physical fitness (muscular strength)
timeFrame: 7 weeks
measure: Physical fitness (upper limbs muscular strength)
timeFrame: 7 weeks
measure: Physical fitness (muscular strength)
timeFrame: 13 weeks
measure: Physical fitness (upper limbs muscular strength)
timeFrame: 13 weeks
measure: Physical fitness (motor skills)
timeFrame: Week 0
measure: Physical fitness (motor skills)
timeFrame: 7 weeks
measure: Physical fitness (motor skills)
timeFrame: 13 weeks
measure: Implicit and explicit attraction to physical activity
timeFrame: Week 0
measure: Implicit and explicit attraction to physical activity
timeFrame: 7 weeks
measure: Implicit and explicit attraction to physical activity
timeFrame: 13 weeks
measure: Teachers' perceptions of students' well-being
timeFrame: Week 0
measure: Teachers' perceptions of students' well-being
timeFrame: 7 weeks
measure: Teachers' perceptions of students' well-being
timeFrame: 13 weeks
measure: Students and teachers' perceived well-being
timeFrame: 7 weeks
measure: Students and teachers' perceived well-being
timeFrame: 13 weeks
measure: Classroom climate/atmosphere
timeFrame: 7 weeks
measure: Classroom climate/atmosphere
timeFrame: 13 weeks
measure: Possible factors of failure of the strategy
timeFrame: 13 weeks
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU clermont-ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Martine Duclos
role: PRINCIPAL_INVESTIGATOR
References: