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Efficacy of the MovinCog Intervention in Children

Primary Purpose

Learning Disorders, Learning Disabilities, Cognitive Change

Status

Unknown status

Phase

Not Applicable

Locations

New Zealand

Study Type

Interventional

Intervention

Exercise

Cognitive

Active control

About this trial

This is an interventional treatment trial for Learning Disorders focused on measuring cognitive training, physical exercise, brain dynamics, cognitive abilities, physiological markers

Eligibility Criteria

7 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Age 7-15

Exclusion Criteria:

Age outside inclusion criteria
History of seizures, brain trauma

Sites / Locations

University of Auckland

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

Exercise and cognitive training

Exercise

Cognitive training

Games

Arm Description

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.

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

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

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.

Outcomes

Primary Outcome Measures

Change from baseline working memory capacity at 10 weeks

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

Change from baseline cognitive control at 10 weeks

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

Change from baseline scholastic aptitude at 10 weeks

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

Secondary Outcome Measures

Change from baseline resting heart rate at 10 weeks

Measured by monitor

BDNF polymorphism measured by genetic saliva kit

Effect of BDNF polymorphism on primary outcomes

Full Information

NCT ID

NCT03255499

First Posted

August 11, 2017

Last Updated

November 5, 2020

Sponsor

University of Auckland, New Zealand

1. Study Identification

Unique Protocol Identification Number

NCT03255499

Brief Title

Efficacy of the MovinCog Intervention in Children

Official Title

Efficacy of the MovinCog Intervention in Children: A Randomized, Placebo-controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Unknown status

Study Start Date

September 10, 2017 (Actual)

Primary Completion Date

December 31, 2021 (Anticipated)

Study Completion Date

December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Auckland, New Zealand

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed Description

Specifically, the investigators will compare both components together (exercise and cognitive training) against either one of the components (exercise alone, or cognitive training alone) and against an active control group. The study will include measures of scholastic aptitude, as well as of working memory and cognitive control (primary outcome measures), two cognitive abilities that are critical to daily life activities, and that respond well to training. In addition, the investigators will measure physiological responses to training, to monitor changes associated with exercise (secondary outcome measures). Finally, the investigators will relate training-specific improvements with transfer gains, to better model the interaction between training and transfer. This will provide a comprehensive understanding of the dynamics associated with the intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Learning Disorders, Learning Disabilities, Cognitive Change

Keywords

cognitive training, physical exercise, brain dynamics, cognitive abilities, physiological markers

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Exercise and cognitive training

Arm Type

Experimental

Arm Description

Arm Title

Exercise

Arm Type

Experimental

Arm Description

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

Arm Title

Cognitive training

Arm Type

Experimental

Arm Description

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

Arm Title

Games

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Exercise

Intervention Description

Exercise

Intervention Type

Behavioral

Intervention Name(s)

Cognitive

Intervention Description

Cognitive

Intervention Type

Behavioral

Intervention Name(s)

Active control

Intervention Description

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

Primary Outcome Measure Information:

Title

Change from baseline working memory capacity at 10 weeks

Description

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

Time Frame

Baseline and 10-week posttest

Title

Change from baseline cognitive control at 10 weeks

Description

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

Time Frame

Baseline and 10-week posttest

Title

Change from baseline scholastic aptitude at 10 weeks

Description

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

Time Frame

Baseline and 10-week posttest

Secondary Outcome Measure Information:

Title

Change from baseline resting heart rate at 10 weeks

Description

Measured by monitor

Time Frame

Baseline and 10-week posttest

Title

BDNF polymorphism measured by genetic saliva kit

Description

Effect of BDNF polymorphism on primary outcomes

Time Frame

Baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

7 Years

Maximum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 7-15 Exclusion Criteria: Age outside inclusion criteria History of seizures, brain trauma

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Moreau

Organizational Affiliation

University of Auckland, New Zealand

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Auckland

City

Auckland

ZIP/Postal Code

1010

Country

New Zealand

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Release IPD at the time of publication.

IPD Sharing Time Frame

Post-publication

IPD Sharing Access Criteria

Unrestricted

IPD Sharing URL

http://github.com/davidmoreau/

Citations:

PubMed Identifier

28825973

Citation

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.

Results Reference

derived

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Efficacy of the MovinCog Intervention in Children

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