Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-02-23 @ 8:07 PM
Study NCT ID:
NCT03391505
Status:
COMPLETED
Last Update Posted:
2024-05-08
First Post:
2017-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Effects of Physical Activity On Memory, Cognitive Performance and Brain Activity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-07', 'studyFirstSubmitDate': '2017-12-21', 'studyFirstSubmitQcDate': '2017-12-29', 'lastUpdatePostDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Event-related brain potentials (P300)', 'timeFrame': '1 day', 'description': 'Electroencephalographic measures (mV) of the neuroelectric system that occur in response to, or in or in preparation for, a discrete event.'}, {'measure': 'Cognitive Response Speed Performance', 'timeFrame': '1 day', 'description': 'Measures of response speed (ms) during the computer-based Flanker task'}, {'measure': 'Cognitive Response Accuracy Performance', 'timeFrame': '1 day', 'description': 'Measures of response accuracy (%) during the computer-based Flanker task'}, {'measure': 'Long-term Memory Accuracy Performance', 'timeFrame': '7 days', 'description': 'Measures of response accuracy (%) during a tablet-based visual memory task'}], 'secondaryOutcomes': [{'measure': 'Height', 'timeFrame': '1 day', 'description': 'Measures of height (cm) with a Tanita Leicester portable altimeter'}, {'measure': 'Weight', 'timeFrame': '1 day', 'description': 'Measures weight (kg) with an InBody 230 multifrequency body composition analyser'}, {'measure': 'Fat Percentage', 'timeFrame': '1 day', 'description': 'Measures fat percentage (%) with an InBody 230 multifrequency body composition'}, {'measure': 'Lean Body Mass', 'timeFrame': '1 day', 'description': 'Measures of lean body mass (kg) with an InBody 230 multifrequency body composition'}, {'measure': 'Fitness Status', 'timeFrame': '1 day', 'description': 'Measures of distance covered during an maximal exercise test'}, {'measure': 'Maximal Heart Rate', 'timeFrame': '1 day', 'description': 'Measures of maximal heart rate with heart rate monitors during an maximal exercise test'}, {'measure': 'Flow', 'timeFrame': '1 day', 'description': 'Measures of flow with a danish translation og the flow questionnaire (Rheinberg et al., 2003) during the intervention'}, {'measure': 'Motivation', 'timeFrame': '1 day', 'description': 'Measures of motivation with the Intrinsic Motivation Inventory (IMI) questionnaire (McAuley et al., 1987) after the intervention'}, {'measure': 'Enjoyment', 'timeFrame': '1 day', 'description': 'Measures of self-perceived enjoyment with the Physical Activity Enjoyment Scale (PACES) (Kendzierski et al., 1991) questionnaire after the intervention'}, {'measure': 'Intervention intensity', 'timeFrame': '1 day', 'description': 'Measures of heart rate with heart rate monitors during the intervention'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cognition', 'Physical activity', 'Memory', 'Health'], 'conditions': ['Mental Health Wellness 1']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent from the childrens´ legal guardians.\n* Physical, linguistic and mental competencies to complete the intervention and testing.\n\nExclusion Criteria:\n\n* Use of prescription-only drugs that kan affect learning ability.\n* Smoking.\n* Neurological diseases inclusive damages to the spinal cord.\n* Children who is not evaluated to being cable of completing the protocol among these psychological diseases or psychological unstable children.'}, 'identificationModule': {'nctId': 'NCT03391505', 'briefTitle': 'Acute Effects of Physical Activity On Memory, Cognitive Performance and Brain Activity', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern Denmark'}, 'officialTitle': 'Acute Effects of Physical Activity On Memory, Cognitive Performance and Brain Activity', 'orgStudyIdInfo': {'id': '59349 to H-16026885'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Group 1', 'description': '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.', 'interventionNames': ['Behavioral: Small-sided soccer game']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Group 2', 'description': '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.', 'interventionNames': ['Behavioral: Walking soccer game']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'description': 'The rest group watching soccer consists of watching a soccer game on a laptop (two times ten minutes) interspersed with a five minutes break.', 'interventionNames': ['Behavioral: Rest group watching soccer']}], 'interventions': [{'name': 'Small-sided soccer game', 'type': 'BEHAVIORAL', 'otherNames': ['SSG'], 'description': '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.', 'armGroupLabels': ['Treatment Group 1']}, {'name': 'Walking soccer game', 'type': 'BEHAVIORAL', 'otherNames': ['WSG'], 'description': '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.', 'armGroupLabels': ['Treatment Group 2']}, {'name': 'Rest group watching soccer', 'type': 'BEHAVIORAL', 'otherNames': ['RES'], 'description': 'The rest group watching soccer consists of watching a soccer game on a laptop (two times ten minutes) interspersed with a five minutes break.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5700', 'city': 'Odense', 'country': 'Denmark', 'facility': 'University of Southern Denmark', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'overallOfficials': [{'name': 'Peter Krustrup', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Southern Denmark'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Copenhagen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Peter Krustrup', 'investigatorAffiliation': 'University of Southern Denmark'}}}}