Learning DisordersNCT03255499
Efficacy of the MovinCog Intervention in Children
A study testing Exercise and Cognitive in people with Learning Disorders and Learning Disabilities, run by University of Auckland, New Zealand at 1 site in New Zealand.
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. Read more about this study
- Who is it for?
- Ages 7 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Learning Disorders, Learning Disabilities, Cognitive Change
- What is being tested?
- Exercise and Cognitive
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteNew Zealand
- Study dates
- 10 Sep 2017to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 7-15
Who cannot join
- Age outside inclusion criteria
- History of seizures, brain trauma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of the MovinCog Intervention in Children: A Randomized, Placebo-controlled Trial
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.
Read the 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.
- Conditions
- Learning Disorders, Learning Disabilities, Cognitive Change
- Being tested
- Exercise, Cognitive, Active control
- Keywords
- cognitive training, physical exercise, brain dynamics, cognitive abilities, physiological markers
- Medical subject headings
- Learning Disabilities, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Exercise
CognitiveBehavioural
Cognitive
Active controlBehavioural
Active control, including a blend of computer games, board games, quizzes, trivia
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Exercise; Behavioral: Cognitive |
| Exercise | Experimental | High-intensity training regimen, 10min/day. Developed for the MovinCog intervention. Receives: Behavioral: Exercise |
| Cognitive training | Experimental | Computerized cognitive training, 20min/day. Developed for the MovinCog intervention. Receives: 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. Receives: Behavioral: Active control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline working memory capacity at 10 weeks
Constructs measured by multiple tasks (bds, corsi, n-back)
Measured: Baseline and 10-week posttest
Change from baseline cognitive control at 10 weeks
Constructs measured by multiple tasks (flanker, go/no-go, stroop)
Measured: Baseline and 10-week posttest
Change from baseline scholastic aptitude at 10 weeks
Constructs measured by multiple national (New Zealand), standardized tests
Measured: Baseline and 10-week posttest
Secondary outcomes (2)
Change from baseline resting heart rate at 10 weeks
Measured by monitor
Measured: Baseline and 10-week posttest
BDNF polymorphism measured by genetic saliva kit
Effect of BDNF polymorphism on primary outcomes
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2017
- Study start10 Sep 2017
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Learning DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Auckland, New Zealand
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Moreau, University of Auckland, New Zealand
- Investigators
- David Moreau, Principal investigator, University of Auckland, New Zealand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03255499
- Sponsor's protocol ID
- MC081017
- Status last verified
- Nov 2020
- First submitted
- 11 Aug 2017
- Last updated
- 9 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Release IPD at the time of publication.
Publications
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.
PubMed 28825973
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the MovinCog Intervention in Children: A Randomized, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT03255499
- Acronym / sponsor ID
- MC081017
- Conditions
- Learning Disorders, Learning Disabilities, Cognitive Change
- Keywords
- cognitive training, physical exercise, brain dynamics, cognitive abilities, physiological markers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of Auckland, New ZealandUniversity, hospital or other
- Study start
- 10 Sep 2017 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 21 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Exercise and cognitive training | Experimental | Behavioral: Exercise, Behavioral: CognitiveThis 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. |
| Exercise | Experimental | Behavioral: ExerciseHigh-intensity training regimen, 10min/day. Developed for the MovinCog intervention. |
| Cognitive training | Experimental | Behavioral: CognitiveComputerized cognitive training, 20min/day. Developed for the MovinCog intervention. |
| Games | Active comparator | Behavioral: Active controlThe 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. |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Age 7-15
Key exclusion criteria (2 listed)
- Age outside inclusion criteria
- History of seizures, brain trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseExercise | Behavioural | Exercise, Exercise and cognitive training |
| CognitiveCognitive | Behavioural | Cognitive training, Exercise and cognitive training |
| Active controlActive control, including a blend of computer games, board games, quizzes, trivia | Behavioural | Games |
Primary outcome
Change from baseline working memory capacity at 10 weeks
Time frame: Baseline and 10-week posttest
Constructs measured by multiple tasks (bds, corsi, n-back)
Change from baseline cognitive control at 10 weeks
Time frame: Baseline and 10-week posttest
Constructs measured by multiple tasks (flanker, go/no-go, stroop)
Change from baseline scholastic aptitude at 10 weeks
Time frame: Baseline and 10-week posttest
Constructs measured by multiple national (New Zealand), standardized tests
2 secondary outcomes
Change from baseline resting heart rate at 10 weeks
Time frame: Baseline and 10-week posttest
BDNF polymorphism measured by genetic saliva kit
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2020.
- Derived from this study: PubMed 28825973Moreau 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.
- Individual participant dataSharing planned: Yes. Release IPD at the time of publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Moreau principal investigator
University of Auckland, New Zealand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Cognitive in people with Learning Disorders and Learning Disabilities, run by University of Auckland, New Zealand at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline working memory capacity at 10 weeks (time frame: Baseline and 10-week posttest). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03255499, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2020.