NCT04880759

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 12, 2021

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 14, 2021

Completed
27 days until next milestone

First Posted

Study publicly available on registry

May 11, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2021

Completed
Last Updated

May 26, 2022

Status Verified

May 1, 2022

Enrollment Period

2 months

First QC Date

April 14, 2021

Last Update Submit

May 25, 2022

Conditions

Cognition

Keywords

Cycling deskActive workstationSedentary BehaviorCognitionChild healthBody compositionPhysical fitness

Outcome Measures

Primary Outcomes (3)

  • Students cognitive abilities

    Time to complete the Trail Making Test part A and B (seconds)

    Week 0

  • Students cognitive abilities

    Time to complete the Trail Making Test part A and B (seconds)

    7 weeks

  • Students cognitive abilities

    Time to complete the Trail Making Test part A and B (seconds)

    13 weeks

Secondary Outcomes (32)

  • Weight

    Week 0

  • Body composition (body mass index)

    Week 0

  • Body composition (body fat mass)

    Week 0

  • Weight

    7 weeks

  • Body composition (body mass index)

    7 weeks

  • +27 more secondary outcomes

Study Arms (1)

Bike desks in classroom

EXPERIMENTAL

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

Other: bike desks in the classroom

Interventions

bike desks in the classroomOTHER

Children will use bike desks for 13 weeks during school time

Bike desks in classroom

Eligibility Criteria

Age8 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU clermont-ferrand

Clermont-Ferrand, France

Location

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Martine Duclos

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2021

First Posted

May 11, 2021

Study Start

April 12, 2021

Primary Completion

June 25, 2021

Study Completion

June 25, 2021

Last Updated

May 26, 2022

Record last verified: 2022-05

Locations

FR(1)