ISRCTN ISRCTN97975679
DOI https://doi.org/10.1186/ISRCTN97975679
Secondary identifying numbers NL43909.029.13
Submission date
10/06/2014
Registration date
07/08/2014
Last edited
05/01/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Physical activity (exercise) isn’t 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 children’s 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

Contact information

Dr Amika Singh
Scientific

van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands

Phone +31 (0)20 4448382
Email a.singh@vumc.nl

Study information

Study designRandomised pilot study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titlePhysical activity, sitting and cognition – a pilot study
Study objectivesWe hypothesized that both one as well as two bouts of moderate-intensity physical activity would enhance children’s selective attention, with larger effects for repeated bouts, when compared to sitting the whole morning.
Ethics approval(s)Medical Ethics Committee of the VU University Medical Center, Amsterdam (The Netherlands), 17/12/2013
Health condition(s) or problem(s) studiedPhysical activity, cognitive functioning
InterventionGroup 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 typeBehavioural
Primary outcome measureSelective attention according to the TEA-CH test, measured at baseline, after 20, 110, 130 and 220 minutes
Secondary outcome measuresFasting blood levels of C-peptide, triglycerides and cholesterol, measured at baseline, after 20, 110, 130 and 220 minutes
Overall study start date01/06/2013
Completion date01/06/2014

Eligibility

Participant type(s)Healthy volunteer
Age groupChild
Lower age limit10 Years
Upper age limit13 Years
SexBoth
Target number of participants60
Key inclusion criteria1. 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.
Key exclusion criteria1. 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.
Date of first enrolment01/06/2013
Date of final enrolment01/06/2014

Locations

Countries of recruitment

  • Netherlands

Study participating centre

van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands

Sponsor information

EMGO Institute for Health and Care Research (Netherlands)
University/education

VU University Medical Center
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands

ROR logo "ROR" https://ror.org/0258apj61

Funders

Funder type

University/education

EMGO Institute for Health and Care Research, VU University Medical Center (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/10/2016 Yes No