NCT01220778

Brief 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

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Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 14, 2010

Completed
Last Updated

October 14, 2010

Status Verified

September 1, 2010

First QC Date

October 13, 2010

Last Update Submit

October 13, 2010

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mismatch negativity

Study Arms (2)

Exercise

EXPERIMENTAL
Behavioral: Exercise

Control

NO INTERVENTION

Interventions

ExerciseBEHAVIORAL
Exercise

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Age GroupsAdult (18-64)

You may qualify if:

  • First trimester of pregnancy
  • to 35 years of age
  • Pre-pregnancy BMI between 18 and 25
  • Primipara
  • Without any known health issues
  • Use of folic acid

You may not qualify if:

  • Use of alcohol, cigarettes or illegal drugs
  • Pregnancy complications
  • Unable or unwilling to breastfeed
  • Excessive or insufficient weight gain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cepsum

Montreal, Quebec, H3T1J4, Canada

RECRUITING

Related Publications (1)

  • LeMoyne EL, Curnier D, St-Jacques S, Ellemberg D. The effects of exercise during pregnancy on the newborn's brain: study protocol for a randomized controlled trial. Trials. 2012 May 29;13:68. doi: 10.1186/1745-6215-13-68.

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Elise L.LeMoyne

    Université de Montréal

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 13, 2010

First Posted

October 14, 2010

Last Updated

October 14, 2010

Record last verified: 2010-09

Locations