Efficacy of the MovinCog Intervention in Children

Cognitive Change Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03255499
• Other study ID #: MC081017
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 10, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: November 2020
• Source: University of Auckland, New Zealand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 15 Years

Eligibility

Inclusion Criteria:

• Age 7-15

Exclusion Criteria:

• Age outside inclusion criteria

• History of seizures, brain trauma

Related Conditions & MeSH terms

• Cognitive Change
• Learning Disabilities
• Learning Disorders

Intervention

Behavioral:
• Exercise
Exercise
• Cognitive
Cognitive
• Active control
Active control, including a blend of computer games, board games, quizzes, trivia

Locations

Country	Name	City	State
New Zealand	University of Auckland	Auckland

Sponsors (1)

Lead Sponsor	Collaborator
University of Auckland, New Zealand

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline working memory capacity at 10 weeks	Constructs measured by multiple tasks (bds, corsi, n-back)	Baseline and 10-week posttest
Primary	Change from baseline cognitive control at 10 weeks	Constructs measured by multiple tasks (flanker, go/no-go, stroop)	Baseline and 10-week posttest
Primary	Change from baseline scholastic aptitude at 10 weeks	Constructs measured by multiple national (New Zealand), standardized tests	Baseline and 10-week posttest
Secondary	Change from baseline resting heart rate at 10 weeks	Measured by monitor	Baseline and 10-week posttest
Secondary	BDNF polymorphism measured by genetic saliva kit	Effect of BDNF polymorphism on primary outcomes	Baseline