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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03255499
Registration number
NCT03255499
Ethics application status
Date submitted
11/08/2017
Date registered
21/08/2017
Date last updated
9/11/2020
Titles & IDs
Public title
Efficacy of the MovinCog Intervention in Children
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Scientific title
Efficacy of the MovinCog Intervention in Children: A Randomized, Placebo-controlled Trial
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Secondary ID [1]
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MC081017
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Learning Disorders
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Learning Disabilities
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Cognitive Change
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Condition category
Condition code
Mental Health
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Learning disabilities
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Behaviour - Exercise
Behaviour - Cognitive
Behaviour - Active control
Experimental: Exercise and cognitive training - 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.
Experimental: Exercise - High-intensity training regimen, 10min/day. Developed for the MovinCog intervention.
Experimental: Cognitive training - Computerized cognitive training, 20min/day. Developed for the MovinCog intervention.
Active Comparator: Games - 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.
Behaviour: Exercise
Exercise
Behaviour: Cognitive
Cognitive
Behaviour: Active control
Active control, including a blend of computer games, board games, quizzes, trivia
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Intervention code [1]
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Behaviour
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change from baseline working memory capacity at 10 weeks
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Assessment method [1]
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Constructs measured by multiple tasks (bds, corsi, n-back)
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Timepoint [1]
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Baseline and 10-week posttest
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Primary outcome [2]
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Change from baseline cognitive control at 10 weeks
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Assessment method [2]
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Constructs measured by multiple tasks (flanker, go/no-go, stroop)
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Timepoint [2]
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Baseline and 10-week posttest
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Primary outcome [3]
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Change from baseline scholastic aptitude at 10 weeks
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Assessment method [3]
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Constructs measured by multiple national (New Zealand), standardized tests
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Timepoint [3]
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Baseline and 10-week posttest
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Secondary outcome [1]
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Change from baseline resting heart rate at 10 weeks
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Assessment method [1]
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Measured by monitor
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Timepoint [1]
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Baseline and 10-week posttest
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Secondary outcome [2]
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BDNF polymorphism measured by genetic saliva kit
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Assessment method [2]
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Effect of BDNF polymorphism on primary outcomes
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Timepoint [2]
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Baseline
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Eligibility
Key inclusion criteria
- Age 7-15
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Minimum age
7
Years
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Maximum age
15
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- Age outside inclusion criteria
- History of seizures, brain trauma
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Unknown status
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
10/09/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/12/2021
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Actual
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Sample size
Target
1000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Auckland, New Zealand
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03255499
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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David Moreau
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Address
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University of Auckland, New Zealand
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03255499
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