NCT03436355

Brief Summary

This study seeks to explore whether increased physical activity in school affects children's executive function, aerobic Fitness and childrens self-regulation. The "Active school" study was a 10-month randomized controlled trial. The sample included 449 children (10-11 years old) in five intervention and four control schools. The weekly interventions were 2×45 minutes physically active academic lessons, 5×10 minutes physically active breaks, and 5×10 minutes physically active homework. Aerobic fitness was measured using a 10-minute interval running test. Executive function was tested using four cognitive tests (Stroop, verbal fluency, digit span, and Trail Making). A composite score for executive function was computed and used in analyses. Self-regulation was measured by the Child Behavior Rating Scale.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
449

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2014

Shorter than P25 for not_applicable

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

August 1, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

February 1, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 19, 2018

Completed
Last Updated

December 5, 2018

Status Verified

December 1, 2018

Enrollment Period

10 months

First QC Date

February 1, 2018

Last Update Submit

December 3, 2018

Conditions

Keywords

BehavioralPhysical activityInterventionSchool children

Outcome Measures

Primary Outcomes (5)

  • Inhibition

    Response inhibition was measured by Stroop Golden color-word test. Participants were naming the printed color of color words while suppressing the reading of the words. The measure was the number of words read in 45 Seconds.

    8 months intervention

  • Working memory

    Working memory was tested by the Wechsler Adult Intelligence Scale (WAIS)-IV-test, a forward and backward digit span, a test that measures working memory function. The measure was the length of the correct series of numbers repeated by the participant. was included

    8 months intervention

  • Cognitive flexibility

    Cognitive flexibility was tested by two tests. First the participants were asked to list all the animals they could think of in 60 seconds as fast as they could.The number of animals was the score. Second, participants performed the Trail Making test. This involves drawing a line connecting consecutive numbers from 1 to 25 as fast as possible. Then participants were drawing a similar line, connecting alternating numbers and letters in sequence, example: 1-A-2-B. Time to complete each "trail" was recorded.

    8 months intervention

  • Aerobic fitness

    Aerobic fitness was assessed by a 10-minute interval running test. The children ran back and forth between two lines placed 20 m apart, touching the ground behind the line with their hand every time they reversed direction. After 15 seconds, a teacher signaled stop and the children rested for 15 seconds before they once more ran for 15 seconds. This procedure lasted 10 minutes, and the running distance was the outcome measure.

    8 months intervention

  • Physical activity

    Physical activity was measured using accelerometry (ActiGraph GT1M/GT3X/GT3X+, LLC, Pensacola, Florida, USA). The children were asked to wear the accelerometer on the right hip for seven consecutive days, removing it only during water-based activities (e.g., swimming) and while sleeping. Data were considered valid if a child had at least two days with a wear time of ≥480 min/day accumulated between 06:00 and 24:00.

    8 months intervention

Secondary Outcomes (1)

  • Self-regulation

    8 months intervention

Study Arms (1)

Physical activity

EXPERIMENTAL

60 minutes of daily physical activity (see intervention)

Behavioral: Physical activity

Interventions

The "Active school" study was a 10-month randomized controlled trial.The weekly interventions were 2×45 minutes physically active academic lessons, 5×10 minutes physically active breaks, and 5×10 minutes physically active homework.

Physical activity

Eligibility Criteria

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

You may qualify if:

  • all children attending 5th grade at the included schools in Stavanger, Norway during the school-year 2014/2015.

You may not qualify if:

  • not able to participate in daily physical activity and physical education and complete the cognitive tests.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Dyrstad SM, Kvalo SE, Alstveit M, Skage I. Physically active academic lessons: acceptance, barriers and facilitators for implementation. BMC Public Health. 2018 Mar 6;18(1):322. doi: 10.1186/s12889-018-5205-3.

  • Kvalo SE, Bru E, Bronnick K, Dyrstad SM. Does increased physical activity in school affect children's executive function and aerobic fitness? Scand J Med Sci Sports. 2017 Dec;27(12):1833-1841. doi: 10.1111/sms.12856. Epub 2017 Mar 16.

  • Seljebotn PH, Skage I, Riskedal A, Olsen M, Kvalo SE, Dyrstad SM. Physically active academic lessons and effect on physical activity and aerobic fitness. The Active School study: A cluster randomized controlled trial. Prev Med Rep. 2018 Dec 28;13:183-188. doi: 10.1016/j.pmedr.2018.12.009. eCollection 2019 Mar.

MeSH Terms

Conditions

Motor ActivityBehavior

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Elaine Munthe, PhD

    University of Stavanger

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

February 1, 2018

First Posted

February 19, 2018

Study Start

August 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

December 5, 2018

Record last verified: 2018-12