Efficacy of the MovinCog Intervention in Children

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Learning Disorders, Learning Disabilities, Cognitive Change

Intervention / Treatment
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* Behavioral: Exercise
* Behavioral: Cognitive
* Behavioral: Active control


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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise and cognitive training<br>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: Exercise<br>* Exercise<br>Behavioral: Cognitive<br>* Cognitive<br>|
| Experimental: Exercise<br>High-intensity training regimen, 10min/day. Developed for the MovinCog intervention. | Behavioral: Exercise<br>* Exercise<br>|
| Experimental: Cognitive training<br>Computerized cognitive training, 20min/day. Developed for the MovinCog intervention. | Behavioral: Cognitive<br>* Cognitive<br>|
| Active Comparator: Games<br>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<br>* Active control, including a blend of computer games, board games, quizzes, trivia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline resting heart rate at 10 weeks | Measured by monitor | Baseline and 10-week posttest | 
| BDNF polymorphism measured by genetic saliva kit | Effect of BDNF polymorphism on primary outcomes | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cognitive training, physical exercise, brain dynamics, cognitive abilities, physiological markers