Plain English Summary
Background and study aims
Physical activity (exercise) isnt just good for a child's health. Research has shown that physical education (PE) and physical activity can also improve academic performance. However, to date, there have been few studies looking into the effects of physical activity on the cognitive functioning (for example thinking, remembering, judging, and problem-solving) in children. Furthermore, the effects of prolonged sitting on the cognitive functioning of children has never been properly investigated, or indeed how physical activity (or prolonged sitting) affects childrens cardiometabolic health (i.e. their risk of developing heart disease or diabetes). Here, we are going to look into how feasible it is to set up a study to measure the effect of physical activity on the cognitive functioning of children when at school.
Who can participate?
Dutch speaking, healthy children between the ages of 10 and 13.
What does the study involve?
All participating children eat the same breakfast in the morning. They are then randomly allocated into one of three groups. Those in group A sit for a prolonged period in their classroom at school (all morning). Those in group B also sit in their classroom, but with an active break (where the children do a physical activity) halfway through the morning. Those in group C start the day with a physical activity, then sit down in their classroom with an active break halfway through the morning. Blood samples are taken from all the children just before they eat their breakfast and then at the end of the morning. They all take part in cognitive functioning tests at various times throughout the morning.
What are the possible benefits and risks of participating?
There is very little risk to taking part in this study. Blood samples are collected using a fingerprick method, a commonly used technique with few risks.
Where is the study run from?
Department of Public and Occupational Health, VU University Medical Centre, Amsterdam (Netherlands)
When is the study starting and how long is it expected to run for?
June 2013 to June 2014
Who is funding the study?
EMGO Institute for Health and Care Research (Netherlands)
Who is the main contact?
Dr Amika Singh
a.singh@vumc.nl
Trial website
Contact information
Type
Scientific
Primary contact
Dr Amika Singh
ORCID ID
Contact details
van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
+31 (0)20 4448382
a.singh@vumc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NL43909.029.13
Study information
Scientific title
Physical activity, sitting and cognition a pilot study
Acronym
Study hypothesis
We hypothesized that both one as well as two bouts of moderate-intensity physical activity would enhance childrens selective attention, with larger effects for repeated bouts, when compared to sitting the whole morning.
Ethics approval
Medical Ethics Committee of the VU University Medical Center, Amsterdam (The Netherlands), 17/12/2013
Study design
Randomised pilot study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Physical activity, cognitive functioning
Intervention
Group A - prolonged sitting
Group B - sitting with an active break halfway the morning
Group C - day start with physical activity, then sitting with an active break halfway the morning
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Selective attention according to the TEA-CH test, measured at baseline, after 20, 110, 130 and 220 minutes
Secondary outcome measures
Fasting blood levels of C-peptide, triglycerides and cholesterol, measured at baseline, after 20, 110, 130 and 220 minutes
Overall trial start date
01/06/2013
Overall trial end date
01/06/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged between 10-13 years
2. Apparently healthy
3. Dutch speaking
Children were requested to refrain from any moderate-to-vigorous physical activity (MVPA) for at least 3 days prior to the experiment.
Participant type
Healthy volunteer
Age group
Child
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. Known physical activity contraindications
2. Major illness/injury (acute or chronic)
3. Physical problems that may limit the ability to perform the experiment
Participants will be screened by a health check questionnaire.
Recruitment start date
01/06/2013
Recruitment end date
01/06/2014
Locations
Countries of recruitment
Netherlands
Trial participating centre
van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
Funders
Funder type
University/education
Funder name
EMGO Institute for Health and Care Research, VU University Medical Center (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26724833