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Trial record 21 of 224 for:    Recruiting, Not yet recruiting, Available Studies | "Mental Health"

Acute Effects of Physical Activity On Memory, Cognitive Performance and Brain Activity

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ClinicalTrials.gov Identifier: NCT03391505
Recruitment Status : Recruiting
First Posted : January 5, 2018
Last Update Posted : February 26, 2018
Sponsor:
Collaborator:
University of Copenhagen
Information provided by (Responsible Party):
Peter Krustrup, University of Southern Denmark

Brief 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 preadolescent children.

Condition or disease Intervention/treatment Phase
Mental Health Wellness 1 Behavioral: Small-sided soccer game Behavioral: Walking soccer game Behavioral: Rest group watching soccer Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Acute Effects of Physical Activity On Memory, Cognitive Performance and Brain Activity
Estimated Study Start Date : March 5, 2018
Estimated Primary Completion Date : May 30, 2018
Estimated Study Completion Date : May 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

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.
Behavioral: Small-sided soccer game
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 Name: SSG

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.
Behavioral: Walking soccer game
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 Name: WSG

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.
Behavioral: Rest group watching soccer
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 Name: RES




Primary Outcome Measures :
  1. 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.

  2. Cognitive Response Speed Performance [ Time Frame: 1 day ]
    Measures of response speed (ms) during the computer-based Flanker task

  3. Cognitive Response Accuracy Performance [ Time Frame: 1 day ]
    Measures of response accuracy (%) during the computer-based Flanker task

  4. Long-term Memory Accuracy Performance [ Time Frame: 7 days ]
    Measures of response accuracy (%) during a tablet-based visual memory task


Secondary Outcome Measures :
  1. Height [ Time Frame: 1 day ]
    Measures of height (cm) with a Tanita Leicester portable altimeter

  2. Weight [ Time Frame: 1 day ]
    Measures weight (kg) with an InBody 230 multifrequency body composition analyser

  3. Fat Percentage [ Time Frame: 1 day ]
    Measures fat percentage (%) with an InBody 230 multifrequency body composition

  4. Lean Body Mass [ Time Frame: 1 day ]
    Measures of lean body mass (kg) with an InBody 230 multifrequency body composition

  5. Fitness Status [ Time Frame: 1 day ]
    Measures of distance covered during an maximal exercise test

  6. Maximal Heart Rate [ Time Frame: 1 day ]
    Measures of maximal heart rate with heart rate monitors during an maximal exercise test

  7. Flow [ Time Frame: 1 day ]
    Measures of flow with a danish translation og the flow questionnaire (Rheinberg et al., 2003) during the intervention

  8. Motivation [ Time Frame: 1 day ]
    Measures of motivation with the Intrinsic Motivation Inventory (IMI) questionnaire (McAuley et al., 1987) after the intervention

  9. 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

  10. Intervention intensity [ Time Frame: 1 day ]
    Measures of heart rate with heart rate monitors during the intervention



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03391505


Contacts
Contact: Rune Lind, PhD (+45)40911109 rrlind@health.sdu.dk
Contact: Svend Sparre Geertsen, Ass. Proff (+45)35327325 ssgeertsen@nexs.ku.dk

Locations
Denmark
University of Southern Denmark Recruiting
Odense, Denmark, 5700
Contact: Rune Lind, PhD    (+45)40911109    rrlind@health.sdu.dk   
Sponsors and Collaborators
University of Southern Denmark
University of Copenhagen
Investigators
Principal Investigator: Peter Krustrup University of Southern Denmark

Responsible Party: Peter Krustrup, Professor, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT03391505     History of Changes
Other Study ID Numbers: 59349 to H-16026885
First Posted: January 5, 2018    Key Record Dates
Last Update Posted: February 26, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Peter Krustrup, University of Southern Denmark:
Cognition
Physical activity
Memory
Health