Condition category
Nutritional, Metabolic, Endocrine
Date applied
20/06/2006
Date assigned
04/07/2007
Last edited
31/01/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

Executive function measured by:
1. Cognitive Assessment System (CAS)
2. Attentional Network Task (ANT)
3. Cambridge Neuropsychological Test Battery (CANTAB)

Secondary outcome measures

Conner’s Attention Deficit Hyperactivity Disorder (ADHD) Index.

Overall trial start date

01/06/2006

Overall trial end date

01/08/2007

Reason abandoned

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

http://www.nhsggc.org.uk/

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

Results - basic reporting

Publication summary

1. 2011 pilot study in http://www.ncbi.nlm.nih.gov/pubmed/22034850

Publication citations

  1. 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.

Additional files

Editorial Notes