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

Sponsor

University Hospital, Clermont-Ferrand (Other)

Overall Status

Completed

CT.gov ID

NCT04880759

Collaborator

Université d'Auvergne (Other)

Enrollment

Location

Arm

2.4

Actual Duration (Months)

30.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cognition	Other: bike desks in the classroom	N/A

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).

Study Design

Study Type:

Interventional

Actual Enrollment :

75 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Apr 12, 2021

Actual Primary Completion Date :

Jun 25, 2021

Actual Study Completion Date :

Jun 25, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bike desks in classroom All participants receive the same intervention: the use of bike desks during school.	Other: bike desks in the classroom Children will use bike desks for 13 weeks during school time

Arm

Intervention/Treatment

Experimental: Bike desks in classroom

All participants receive the same intervention: the use of bike desks during school.

Other: bike desks in the classroom

Children will use bike desks for 13 weeks during school time

Outcome Measures

Primary Outcome Measures

Students cognitive abilities [Week 0]
Time to complete the Trail Making Test part A and B (seconds)
Students cognitive abilities [7 weeks]
Time to complete the Trail Making Test part A and B (seconds)
Students cognitive abilities [13 weeks]
Time to complete the Trail Making Test part A and B (seconds)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 11 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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