- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03391505
Acute Effects of Physical Activity On Memory, Cognitive Performance and Brain Activity
February 22, 2018 updated by: Peter Krustrup, University of Southern Denmark
The overall aim of the study is to investigate the effects of an acute bout of physical activity on cognitive performance and long-term memory in elementary school children.
Elaborating, the study seeks to investigate the effect of the intensity of the physical activity on cognitive performance and long-term memory in preadolescent children.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Based on a power analysis a total population of 100 children (four school classes) will be invited to participate in a 10-day protocol.
The children will be randomly allocated, within their cluster (classes) and stratified for gender and soccer level, to one of 3 intervention groups.
The groups consist of: A small-sides soccer game group (SSG), a walking soccer group (WSG) and a rest group watching soccer on TV (RES).
At day 1 the children will complete a screening of their physical characteristics (height, weight, fat percentages, lean muscle mass and fitness status).
On day 2 the children will complete a screening and a familiarization to the cognitive tasks used (cognitive performance and long-term memory) and the brain activity measuring devices (transportable EEG systems).
On day 3 the children will complete the interventions, which first consist a long-term memory task, where the children will be asked to remember forty different pictures.
Immediately after exposure to the forty pictures, the children will participate in 2 x 10 minutes of their respective interventions with 5 minutes break in between.
During the break, the children will complete a short questionnaire to address their flow.
Furthermore, during the intervention they will be equipped with heart rate monitors to quantify the physical demands of the intervention.
Immediately after completing the 2 x 10 minutes interventions the children will be equipped with a transportable EEG system, and undergo a cognitive test (the Flanker task) to address their cognitive performance.
The EEG recordings are used to measure the P3 amplitude and latency, biomarkers for cognitive performance.
While equipping the children with the EEG system, the children will complete questionnaires about their participation.
At day 10 the children will try to remember as many pictures of the forty pictures as possible to address the effect of the interventions on their long-term memory.
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Rune Lind, PhD
- Phone Number: (+45)40911109
- Email: rrlind@health.sdu.dk
Study Contact Backup
- Name: Svend Sparre Geertsen, Ass. Proff
- Phone Number: (+45)35327325
- Email: ssgeertsen@nexs.ku.dk
Study Locations
-
-
-
Odense, Denmark, 5700
- Recruiting
- University of Southern Denmark
-
Contact:
- Rune Lind, PhD
- Phone Number: (+45)40911109
- Email: rrlind@health.sdu.dk
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 14 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Informed consent from the childrens´ legal guardians.
- Physical, linguistic and mental competencies to complete the intervention and testing.
Exclusion Criteria:
- Use of prescription-only drugs that kan affect learning ability.
- Smoking.
- Neurological diseases inclusive damages to the spinal cord.
- Children who is not evaluated to being cable of completing the protocol among these psychological diseases or psychological unstable children.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment Group 1
The small-sided soccer game consists of a single bout (two times ten minutes) of small-sided soccer game (3v3) interspersed with a five minutes break.
|
The small-sided soccer game consists of a single bout (two times ten minutes) of small-sided soccer game (3v3) interspersed with a five minutes break.
Other Names:
|
Experimental: Treatment Group 2
The walking soccer game consists of a single bout (two times ten minutes) of small-sided walking soccer game (3v3) interspersed with a five minutes break.
|
The walking soccer game consists of a single bout (two times ten minutes) of small-sided walking soccer game (3v3) interspersed with a five minutes break.
Other Names:
|
Placebo Comparator: Control Group
The rest group watching soccer consists of watching a soccer game on a laptop (two times ten minutes) interspersed with a five minutes break.
|
The rest group watching soccer consists of watching a soccer game on a laptop (two times ten minutes) interspersed with a five minutes break.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Event-related brain potentials (P300)
Time Frame: 1 day
|
Electroencephalographic measures (mV) of the neuroelectric system that occur in response to, or in or in preparation for, a discrete event.
|
1 day
|
Cognitive Response Speed Performance
Time Frame: 1 day
|
Measures of response speed (ms) during the computer-based Flanker task
|
1 day
|
Cognitive Response Accuracy Performance
Time Frame: 1 day
|
Measures of response accuracy (%) during the computer-based Flanker task
|
1 day
|
Long-term Memory Accuracy Performance
Time Frame: 7 days
|
Measures of response accuracy (%) during a tablet-based visual memory task
|
7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Height
Time Frame: 1 day
|
Measures of height (cm) with a Tanita Leicester portable altimeter
|
1 day
|
Weight
Time Frame: 1 day
|
Measures weight (kg) with an InBody 230 multifrequency body composition analyser
|
1 day
|
Fat Percentage
Time Frame: 1 day
|
Measures fat percentage (%) with an InBody 230 multifrequency body composition
|
1 day
|
Lean Body Mass
Time Frame: 1 day
|
Measures of lean body mass (kg) with an InBody 230 multifrequency body composition
|
1 day
|
Fitness Status
Time Frame: 1 day
|
Measures of distance covered during an maximal exercise test
|
1 day
|
Maximal Heart Rate
Time Frame: 1 day
|
Measures of maximal heart rate with heart rate monitors during an maximal exercise test
|
1 day
|
Flow
Time Frame: 1 day
|
Measures of flow with a danish translation og the flow questionnaire (Rheinberg et al., 2003) during the intervention
|
1 day
|
Motivation
Time Frame: 1 day
|
Measures of motivation with the Intrinsic Motivation Inventory (IMI) questionnaire (McAuley et al., 1987) after the intervention
|
1 day
|
Enjoyment
Time Frame: 1 day
|
Measures of self-perceived enjoyment with the Physical Activity Enjoyment Scale (PACES) (Kendzierski et al., 1991) questionnaire after the intervention
|
1 day
|
Intervention intensity
Time Frame: 1 day
|
Measures of heart rate with heart rate monitors during the intervention
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Peter Krustrup, University of Southern Denmark
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
March 5, 2018
Primary Completion (Anticipated)
May 30, 2018
Study Completion (Anticipated)
May 30, 2018
Study Registration Dates
First Submitted
December 21, 2017
First Submitted That Met QC Criteria
December 29, 2017
First Posted (Actual)
January 5, 2018
Study Record Updates
Last Update Posted (Actual)
February 26, 2018
Last Update Submitted That Met QC Criteria
February 22, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 59349 to H-16026885
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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