| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN70853932 |
| Date ISRCTN assigned | 04/07/2007 |
| Local reference number(s) | N/A |
| Public title | Chronic effect of exercise on attention and working memory in children |
| Scientific title |
|
| Acronym | LEAPFROG - CHRONIC |
| Disease/condition/study domain | Obesity |
| 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 |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Received from Yorkhill Hospitals Glasgow LREC (ref.: 05/s0708/89). |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Healthy children age 6 - 8 years attending mainstream primary schools. |
| Participants - exclusion criteria | Diagnosis of any disorder of attention or memory. |
| Patient information material |
|
| Anticipated start date | 01/06/2006 |
| Anticipated end date | 01/08/2007 |
| Status of trial | Completed |
| Target number of participants | 60 to 80 (30 to 40 in each group) |
| Interventions | 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. |
| Primary outcome measure(s) | Executive function measured by:
1. Cognitive Assessment System (CAS)
2. Attentional Network Task (ANT)
3. Cambridge Neuropsychological Test Battery (CANTAB) |
| Secondary outcome measure(s) | Conner¿s Attention Deficit Hyperactivity Disorder (ADHD) Index. |
| Sources of funding | 1. Scottish Executive Health Department (UK)
2. Chief Scientist's Office (UK)
3. Yorkhill Children's Foundation Studentship (UK) |
| Sponsor name | 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
United Kingdom
G3 8SJ |
| Sponsor website | http://www.nhsggc.org.uk/ |
| Contact name | Prof John Reilly |
| Contact details | Division of Developmental Medicine
University of Glasgow
1st Floor Tower Block, QMH
Yorkhill Hospitals
Dalnair Street
Glasgow
United Kingdom
G3 8SJ |
| Contact email | jjr2y@clinmed.gla.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN70853932 |
| Date last extracted from ISRCTN register | 17/04/2008 |
