Contact information
Type
Scientific
Primary contact
Prof John Reilly
ORCID ID
Contact details
Division of Developmental Medicine
University of Glasgow
1st Floor Tower Block
QMH
Yorkhill Hospitals
Dalnair Street
Glasgow
G3 8SJ
United Kingdom
jjr2y@clinmed.gla.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
LEAPFROG - CHRONIC
Study hypothesis
There is increasing concern that modern children lead very sedentary lives. An inactive lifestyle increases risks of obesity and metabolic disease, but may also have adverse effects on cognitive function. Two recent systematic reviews/meta-analyses have concluded that there is a need for a Randomised Controlled Trial (RCT) to test the hypothesis that exercise can affect cognition in children, and to determine dose-response relationships. The aim of this study is:
1. To test the hypothesis that chronic aerobic exercise has effects on attention and working memory in children
2. To pilot for a larger scale future RCT
Ethics approval
Received from Yorkhill Hospitals Glasgow LREC (ref.: 05/s0708/89).
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Obesity
Intervention
Intervention group:
Aerobic exercise sessions for approximately 90 minutes per week delivered as physical education.
Control group:
Flexibility strength skill development for approximately 90 minutes per week, delivered as physical education.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Executive function measured by:
1. Cognitive Assessment System (CAS)
2. Attentional Network Task (ANT)
3. Cambridge Neuropsychological Test Battery (CANTAB)
Secondary outcome measures
Conners Attention Deficit Hyperactivity Disorder (ADHD) Index.
Overall trial start date
01/06/2006
Overall trial end date
01/08/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Healthy children age 6 - 8 years attending mainstream primary schools.
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
60 to 80 (30 to 40 in each group)
Participant exclusion criteria
Diagnosis of any disorder of attention or memory.
Recruitment start date
01/06/2006
Recruitment end date
01/08/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Division of Developmental Medicine
Glasgow
G3 8SJ
United Kingdom
Sponsor information
Organisation
Yorkhills Hospitals NHS Trust (UK)
Sponsor details
Dr Alison Wood
R & D Office
Harley Street
Royal Hospital for Sick Children
Yorkhill Hospitals
Dalnair Street
Glasgow
G3 8SJ
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Scottish Executive Health Department (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Chief Scientist's Office (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Yorkhill Children's Foundation Studentship (UK)
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
1. 2011 pilot study in http://www.ncbi.nlm.nih.gov/pubmed/22034850
Publication citations
-
Pilot study
Fisher A, Boyle JM, Paton JY, Tomporowski P, Watson C, McColl JH, Reilly JJ, Effects of a physical education intervention on cognitive function in young children: randomized controlled pilot study., BMC Pediatr, 2011, 11, 97, doi: 10.1186/1471-2431-11-97.