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

Cognition Clinical Trial

— BICLASS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04880759
• Other study ID #: RBHP 2021 DUCLOS
• Secondary ID: 2021-A00114-37
• Status: Completed
• Phase: N/A
• Start date: April 12, 2021
• Est. completion date: June 25, 2021

Study information

• Verified date: May 2022
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: June 25, 2021
• Est. primary completion date: June 25, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognition

Intervention

Other:
• bike desks in the classroom
Children will use bike desks for 13 weeks during school time

Locations

Country	Name	City	State
France	CHU clermont-ferrand	Clermont-Ferrand

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Université d'Auvergne

Country where clinical trial is conducted

France, 

Outcome

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