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NCT01220778 Clinical Trial

Effects of Physical Activity During Pregnancy on the Newborn's Cognitive Function

Pregnancy Clinical Trial

Official title:
Effects of Physical Activity During Pregnancy on the Newborn's Cognitive Function, the Healthy Mom, Bright Child Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01220778
Other study ID # CERSS-2010-951-P
Secondary ID
Status Recruiting
Phase N/A
First received October 13, 2010
Last updated October 13, 2010

Study information
Verified date September 2010
Source Université de Montréal
Contact Elise L. LeMoyne
Phone 514-343-6111
Email apgrossesse@kinesio.umontreal.ca
Is FDA regulated No
Health authority Canada: Canadian Institutes of Health ResearchCanada: Ethics Review CommitteeCanada: Health Canada
Study type Interventional

Clinical Trial Summary

Background: It is now generally accepted that an active lifestyle is beneficial for cognition, but can these benefits be transmitted for the active pregnant woman to her unborn child? This has been demonstrated in rats where the pups born of mothers who exercised during pregnancy had increased hippocampal neurogenesis and better memory and learning capabilities. Human studies tend to confirm this by looking at behavioral results, ie. better orientation and state regulation skills in newborns. The aim of the present study is to verify this on the electrophysiological level and to determine the effects of an active lifestyle during pregnancy on the newborn's brain development.

Methods: 60 pregnant women will be included in a randomized controlled trial. The exercise group will be asked to exercise a minimum of 20 minutes, 3 times per week, at a minimal intensity of 55% of their maximal aerobic capacity. The control group will not be given exercise counselling. Newborns' brain activity will be recorded using electroencephalography (EEG) 10 days post partum. The primary outcome measure will be the amplitude and latency of the mismatch negativity (MMN), a component of the auditory event-related potential (ERP) that can be used to investigate the auditory sensory memory.

Recruitment information / eligibility
Status Recruiting
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Female
Age group 20 Years to 35 Years
Eligibility Inclusion Criteria:

- First trimester of pregnancy

- 20 to 35 years of age

- Pre-pregnancy BMI between 18 and 25

- Primipara

- Without any known health issues

- Use of folic acid

Exclusion Criteria:

- Use of alcohol, cigarettes or illegal drugs

- Pregnancy complications

- Unable or unwilling to breastfeed

- Excessive or insufficient weight gain

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment

Related Conditions & MeSH terms

Intervention

Behavioral:
• Exercise

Locations
Country Name City State
Canada Cepsum Montreal Quebec

Sponsors (1)
Lead Sponsor Collaborator
Université de Montréal

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mismatch negativity
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