CognitionBICLASSNCT04880759
Pilot Study of Active Desk in Primary School : Effects on Cognitive Capacities, Physical Capacities and Well-being
A study testing bike desks in the classroom in people with Cognition, run by University Hospital, Clermont-Ferrand at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 8 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognition
- What is being tested?
- bike desks in the classroom
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteFrance
- Study dates
- 12 Apr 2021to 25 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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).
- Conditions
- Cognition
- Being tested
- bike desks in the classroom
- Keywords
- Cycling desk, Active workstation, Sedentary Behavior, Cognition, Child health, Body composition, Physical fitness
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bike desks in the classroomOther
Children will use bike desks for 13 weeks during school time
| Study group | Role | What they receive |
|---|---|---|
| Bike desks in classroom | Experimental | All participants receive the same intervention: the use of bike desks during school. Receives: Other: bike desks in the classroom |
What is being measured
The primary outcome is the main question the study is designed to answer.
Students cognitive abilities
Time to complete the Trail Making Test part A and B (seconds)
Measured: Week 0
Students cognitive abilities
Time to complete the Trail Making Test part A and B (seconds)
Measured: 7 weeks
Students cognitive abilities
Time to complete the Trail Making Test part A and B (seconds)
Measured: 13 weeks
Secondary outcomes (32)
Weight
Weight (kg) will be assessed by bioimpedance analysis with Tanita MC-780 (Tanita Corp., Tokyo, Japan)
Measured: Week 0
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
Measured: Week 0
Body composition (body fat mass)
Body fat mass (%) will be assessed by bioimpedance analysis with Tanita MC-780 (Tanita Corp., Tokyo, Japan)
Measured: Week 0
Weight
Weight (kg) will be assessed by bioimpedance analysis with Tanita MC-780 (Tanita Corp., Tokyo, Japan)
Measured: 7 weeks
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
Measured: 7 weeks
Body composition (body fat mass)
Body fat mass (%) will be assessed by bioimpedance analysis with Tanita MC-780 (Tanita Corp., Tokyo, Japan)
Measured: 7 weeks
Weight
Weight (kg) will be assessed by bioimpedance analysis with Tanita MC-780 (Tanita Corp., Tokyo, Japan)
Measured: 13 weeks
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
Measured: 13 weeks
Body composition (body fat mass)
Body fat mass (%) will be assessed by bioimpedance analysis with Tanita MC-780 (Tanita Corp., Tokyo, Japan)
Measured: 13 weeks
Physical fitness (cardio-respiratory capacity)
Cardio-respiratory capacity will be assessed with 20 m shuttle test (ml.mn.kg-1)
Measured: Week 0
Physical fitness (cardio-respiratory capacity)
Cardio-respiratory capacity will be assessed with 20 m shuttle test (ml.mn.kg-1)
Measured: 7 weeks
Physical fitness (cardio-respiratory capacity)
Cardio-respiratory capacity will be assessed with 20 m shuttle test (ml.mn.kg-1)
Measured: 13 weeks
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)
Measured: Week 0
Physical fitness (upper limbs muscular strength)
Muscular strength will be assessed with Handgrip test (kg)
Measured: Week 0
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)
Measured: 7 weeks
Physical fitness (upper limbs muscular strength)
Muscular strength will be assessed with Handgrip test (kg)
Measured: 7 weeks
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)
Measured: 13 weeks
Physical fitness (upper limbs muscular strength)
Muscular strength will be assessed with Handgrip test (kg)
Measured: 13 weeks
Physical fitness (motor skills)
Motor skills will be assessed with the time to complete an obstacle course (seconds)
Measured: Week 0
Physical fitness (motor skills)
Motor skills will be assessed with the time to complete an obstacle course (seconds)
Measured: 7 weeks
Physical fitness (motor skills)
Motor skills will be assessed with the time to complete an obstacle course (seconds)
Measured: 13 weeks
Implicit and explicit attraction to physical activity
Implicit and explicit attraction to physical activity will be assessed with Activity Preference Assessment (APA) computer test
Measured: Week 0
Implicit and explicit attraction to physical activity
Implicit and explicit attraction to physical activity will be assessed with Activity Preference Assessment (APA) computer test
Measured: 7 weeks
Implicit and explicit attraction to physical activity
Implicit and explicit attraction to physical activity will be assessed with Activity Preference Assessment (APA) computer test
Measured: 13 weeks
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.
Measured: Week 0
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.
Measured: 7 weeks
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.
Measured: 13 weeks
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.
Measured: 7 weeks
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.
Measured: 13 weeks
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.
Measured: 7 weeks
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.
Measured: 13 weeks
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.
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start12 Apr 2021
- Primary completion25 Jun 2021
- Study completion25 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CognitionStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Université d'Auvergne
- Responsible party
- Sponsor
- Investigators
- Martine Duclos, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04880759
- Sponsor's protocol ID
- RBHP 2021 DUCLOS
- Other IDs
- 2021-A00114-37
- Acronym
- BICLASS
- Status last verified
- May 2022
- First submitted
- 14 Apr 2021
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04880759
- Acronym / sponsor ID
- BICLASS / RBHP 2021 DUCLOS
- Conditions
- Cognition
- Keywords
- Cycling desk, Active workstation, Sedentary Behavior, Cognition, Child health, Body composition, Physical fitness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Université d'Auvergne
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 25 Jun 2021 (actual)
- Study completion
- 25 Jun 2021 (actual)
- First posted
- 11 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bike desks in classroom | Experimental | Other: bike desks in the classroomAll participants receive the same intervention: the use of bike desks during school. |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bike desks in the classroomChildren will use bike desks for 13 weeks during school time | Other | Bike desks in classroom |
Primary outcome
Students cognitive abilities
Time frame: Week 0
Time to complete the Trail Making Test part A and B (seconds)
Students cognitive abilities
Time frame: 7 weeks
Time to complete the Trail Making Test part A and B (seconds)
Students cognitive abilities
Time frame: 13 weeks
Time to complete the Trail Making Test part A and B (seconds)
32 secondary outcomes
Weight
Time frame: Week 0
Body composition (body mass index)
Time frame: Week 0
Body composition (body fat mass)
Time frame: Week 0
Weight
Time frame: 7 weeks
Body composition (body mass index)
Time frame: 7 weeks
Body composition (body fat mass)
Time frame: 7 weeks
Weight
Time frame: 13 weeks
Body composition (body mass index)
Time frame: 13 weeks
Body composition (body fat mass)
Time frame: 13 weeks
Physical fitness (cardio-respiratory capacity)
Time frame: Week 0
Physical fitness (cardio-respiratory capacity)
Time frame: 7 weeks
Physical fitness (cardio-respiratory capacity)
Time frame: 13 weeks
Physical fitness (muscular strength)
Time frame: Week 0
Physical fitness (upper limbs muscular strength)
Time frame: Week 0
Physical fitness (muscular strength)
Time frame: 7 weeks
Physical fitness (upper limbs muscular strength)
Time frame: 7 weeks
Physical fitness (muscular strength)
Time frame: 13 weeks
Physical fitness (upper limbs muscular strength)
Time frame: 13 weeks
Physical fitness (motor skills)
Time frame: Week 0
Physical fitness (motor skills)
Time frame: 7 weeks
Physical fitness (motor skills)
Time frame: 13 weeks
Implicit and explicit attraction to physical activity
Time frame: Week 0
Implicit and explicit attraction to physical activity
Time frame: 7 weeks
Implicit and explicit attraction to physical activity
Time frame: 13 weeks
Teachers' perceptions of students' well-being
Time frame: Week 0
Teachers' perceptions of students' well-being
Time frame: 7 weeks
Teachers' perceptions of students' well-being
Time frame: 13 weeks
Students and teachers' perceived well-being
Time frame: 7 weeks
Students and teachers' perceived well-being
Time frame: 13 weeks
Classroom climate/atmosphere
Time frame: 7 weeks
Classroom climate/atmosphere
Time frame: 13 weeks
Possible factors of failure of the strategy
Time frame: 13 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martine Duclos principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bike desks in the classroom in people with Cognition, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Students cognitive abilities (time frame: Week 0). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2022.