Mental Health Wellness 1NCT03391505
Acute Effects of Physical Activity On Memory, Cognitive Performance and Brain Activity
A study testing Small-sided soccer game, Walking soccer game and Rest group watching soccer in people with Mental Health Wellness 1, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 10 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Wellness 1
- What is being tested?
- Small-sided soccer game, Walking soccer game and Rest group watching soccer
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteDenmark
- Study dates
- 5 Feb 2018to 30 Apr 2018
- 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 10 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Informed consent from the childrens´ legal guardians.
- Physical, linguistic and mental competencies to complete the intervention and testing.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Mental Health Wellness 1
- Being tested
- Small-sided soccer game, Walking soccer game, Rest group watching soccer
- Keywords
- Cognition, Physical activity, Memory, Health
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Small-sided soccer gameBehavioural
Also called SSG
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.
Walking soccer gameBehavioural
Also called WSG
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.
Rest group watching soccerBehavioural
Also called RES
The rest group watching soccer consists of watching a soccer game on a laptop (two times ten minutes) interspersed with a five minutes break.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group 1 | Experimental | 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. Receives: Behavioral: Small-sided soccer game |
| Treatment Group 2 | Experimental | 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. Receives: Behavioral: Walking soccer game |
| Control Group | Placebo comparator | The rest group watching soccer consists of watching a soccer game on a laptop (two times ten minutes) interspersed with a five minutes break. Receives: Behavioral: Rest group watching soccer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-related brain potentials (P300)
Electroencephalographic measures (mV) of the neuroelectric system that occur in response to, or in or in preparation for, a discrete event.
Measured: 1 day
Cognitive Response Speed Performance
Measures of response speed (ms) during the computer-based Flanker task
Measured: 1 day
Cognitive Response Accuracy Performance
Measures of response accuracy (%) during the computer-based Flanker task
Measured: 1 day
Long-term Memory Accuracy Performance
Measures of response accuracy (%) during a tablet-based visual memory task
Measured: 7 days
Secondary outcomes (10)
Height
Measures of height (cm) with a Tanita Leicester portable altimeter
Measured: 1 day
Weight
Measures weight (kg) with an InBody 230 multifrequency body composition analyser
Measured: 1 day
Fat Percentage
Measures fat percentage (%) with an InBody 230 multifrequency body composition
Measured: 1 day
Lean Body Mass
Measures of lean body mass (kg) with an InBody 230 multifrequency body composition
Measured: 1 day
Fitness Status
Measures of distance covered during an maximal exercise test
Measured: 1 day
Maximal Heart Rate
Measures of maximal heart rate with heart rate monitors during an maximal exercise test
Measured: 1 day
Flow
Measures of flow with a danish translation og the flow questionnaire (Rheinberg et al., 2003) during the intervention
Measured: 1 day
Motivation
Measures of motivation with the Intrinsic Motivation Inventory (IMI) questionnaire (McAuley et al., 1987) after the intervention
Measured: 1 day
Enjoyment
Measures of self-perceived enjoyment with the Physical Activity Enjoyment Scale (PACES) (Kendzierski et al., 1991) questionnaire after the intervention
Measured: 1 day
Intervention intensity
Measures of heart rate with heart rate monitors during the intervention
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2018
- Study start5 Feb 2018
- Primary completion30 Apr 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health Wellness 1Studies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Principal investigator, Peter Krustrup, University of Southern Denmark
- Investigators
- Peter Krustrup, Principal investigator, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03391505
- Sponsor's protocol ID
- 59349 to H-16026885
- Status last verified
- May 2024
- First submitted
- 21 Dec 2017
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Physical Activity On Memory, Cognitive Performance and Brain Activity
- ClinicalTrials.gov ID
- NCT03391505
- Acronym / sponsor ID
- 59349 to H-16026885
- Conditions
- Mental Health Wellness 1
- Keywords
- Cognition, Physical activity, Memory, Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- 5 Feb 2018 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 5 Jan 2018 (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.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment Group 1 | Experimental | Behavioral: Small-sided soccer gameThe 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. |
| Treatment Group 2 | Experimental | Behavioral: Walking soccer gameThe 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. |
| Control Group | Placebo comparator | Behavioral: Rest group watching soccerThe rest group watching soccer consists of watching a soccer game on a laptop (two times ten minutes) interspersed with a five minutes break. |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Informed consent from the childrens´ legal guardians.
- Physical, linguistic and mental competencies to complete the intervention and testing.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Small-sided soccer gameAlso: SSGThe 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. | Behavioural | Treatment Group 1 |
| Walking soccer gameAlso: WSGThe 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. | Behavioural | Treatment Group 2 |
| Rest group watching soccerAlso: RESThe rest group watching soccer consists of watching a soccer game on a laptop (two times ten minutes) interspersed with a five minutes break. | Behavioural | Control Group |
Primary outcome
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.
Cognitive Response Speed Performance
Time frame: 1 day
Measures of response speed (ms) during the computer-based Flanker task
Cognitive Response Accuracy Performance
Time frame: 1 day
Measures of response accuracy (%) during the computer-based Flanker task
Long-term Memory Accuracy Performance
Time frame: 7 days
Measures of response accuracy (%) during a tablet-based visual memory task
10 secondary outcomes
Height
Time frame: 1 day
Weight
Time frame: 1 day
Fat Percentage
Time frame: 1 day
Lean Body Mass
Time frame: 1 day
Fitness Status
Time frame: 1 day
Maximal Heart Rate
Time frame: 1 day
Flow
Time frame: 1 day
Motivation
Time frame: 1 day
Enjoyment
Time frame: 1 day
Intervention intensity
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: No
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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.
Peter Krustrup principal investigator
University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Small-sided soccer game, Walking soccer game and Rest group watching soccer in people with Mental Health Wellness 1, run by University of Southern Denmark at 1 site in Denmark.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 8 May 2024. 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 Denmark. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Event-related brain potentials (P300) (time frame: 1 day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 May 2024.