NCT03255499

Brief Summary

This study aims to test the efficacy of the MovinCog Intervention to enhance cognitive abilities in children 7-15 yrs. The intervention consists of two parts: a physical exercise regimen, based on high-intensity training, and a cognitive training component. The design will contrast the intervention with an active control group, matched for expectancy effects.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

August 11, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 21, 2017

Completed
20 days until next milestone

Study Start

First participant enrolled

September 10, 2017

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

November 9, 2020

Status Verified

November 1, 2020

Enrollment Period

4.3 years

First QC Date

August 11, 2017

Last Update Submit

November 5, 2020

Conditions

Learning DisordersLearning DisabilitiesCognitive Change

Keywords

cognitive trainingphysical exercisebrain dynamicscognitive abilitiesphysiological markers

Outcome Measures

Primary Outcomes (3)

  • Change from baseline working memory capacity at 10 weeks

    Constructs measured by multiple tasks (bds, corsi, n-back)

    Baseline and 10-week posttest

  • Change from baseline cognitive control at 10 weeks

    Constructs measured by multiple tasks (flanker, go/no-go, stroop)

    Baseline and 10-week posttest

  • Change from baseline scholastic aptitude at 10 weeks

    Constructs measured by multiple national (New Zealand), standardized tests

    Baseline and 10-week posttest

Secondary Outcomes (2)

  • Change from baseline resting heart rate at 10 weeks

    Baseline and 10-week posttest

  • BDNF polymorphism measured by genetic saliva kit

    Baseline

Study Arms (4)

Exercise and cognitive training

EXPERIMENTAL

This intervention includes a combination of high-intensity exercise (10min/day) and computerized cognitive training (20min/day). The software for the latter has been developed by our group, and includes 8 mini-games targeting different cognitive abilities. Both are developed for the MovinCog intervention. The intervention is personalized, based on individual performance.

Behavioral: ExerciseBehavioral: Cognitive

Exercise

EXPERIMENTAL

High-intensity training regimen, 10min/day. Developed for the MovinCog intervention.

Behavioral: Exercise

Cognitive training

EXPERIMENTAL

Computerized cognitive training, 20min/day. Developed for the MovinCog intervention.

Behavioral: Cognitive

Games

ACTIVE COMPARATOR

The active control is composed of a blend of board games, computer games, and trivia quizzes. Specific content is personalized based on individual preferences, so as to reflect the flexibility of the experimental arms.

Behavioral: Active control

Interventions

ExerciseBEHAVIORAL

Exercise

ExerciseExercise and cognitive training
CognitiveBEHAVIORAL

Cognitive

Cognitive trainingExercise and cognitive training
Active controlBEHAVIORAL

Active control, including a blend of computer games, board games, quizzes, trivia

Games

Eligibility Criteria

Age7 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Age 7-15

You may not qualify if:

  • History of seizures, brain trauma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Auckland

Auckland, 1010, New Zealand

Location

Related Publications (1)

  • Moreau D, Kirk IJ, Waldie KE. High-intensity training enhances executive function in children in a randomized, placebo-controlled trial. Elife. 2017 Aug 22;6:e25062. doi: 10.7554/eLife.25062.

    PMID: 28825973DERIVED

MeSH Terms

Conditions

Learning DisabilitiesMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Communication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • David Moreau

    University of Auckland, New Zealand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

August 11, 2017

First Posted

August 21, 2017

Study Start

September 10, 2017

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

November 9, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will share

Release IPD at the time of publication.

Shared Documents
STUDY PROTOCOL, ANALYTIC CODE
Time Frame
Post-publication
Access Criteria
Unrestricted
More information

Locations

NZ(1)