PregnancyNCT01220778
Effects of Physical Activity During Pregnancy on the Newborn's Cognitive Function
A study testing Exercise in people with Pregnancy, run by Université de Montréal at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteCanada
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- Adult
Who may be able to join
- 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
Who cannot join
- Use of alcohol, cigarettes or illegal drugs
- Pregnancy complications
- Unable or unwilling to breastfeed
- Excessive or insufficient weight gain
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Cepsum
Montreal, Quebec, H3T1J4
Elise L.LeMoyne, 514-343-6111 ext. 5380, apgrossesse@kinesio.umontreal.ca
About this study
Official title: Effects of Physical Activity During Pregnancy on the Newborn's Cognitive Function, the Healthy Mom, Bright Child Randomized Trial
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.
- Conditions
- Pregnancy
- Being tested
- Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Not described Receives: Behavioral: Exercise |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mismatch negativity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
Sponsor and investigators
- Lead sponsor
- Université de Montréal
- Sponsor type
- University, hospital or other
- Investigators
- Elise L.LeMoyne, Principal investigator, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01220778
- Sponsor's protocol ID
- CERSS-2010-951-P
- Status last verified
- Sep 2010
- First submitted
- 13 Oct 2010
- Last updated
- 14 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22643160
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Physical Activity During Pregnancy on the Newborn's Cognitive Function, the Healthy Mom, Bright Child Randomized Trial
- ClinicalTrials.gov ID
- NCT01220778
- Acronym / sponsor ID
- CERSS-2010-951-P
- Conditions
- Pregnancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Université de MontréalUniversity, hospital or other
- First posted
- 14 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: Exercise |
| Control | No intervention | – |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Age groups
- Adult
Key inclusion criteria (6 listed)
- First trimester of pregnancy
- 20 to 35 years of age
- Pre-pregnancy BMI between 18 and 25
- Primipara
- Without any known health issues
Key exclusion criteria (4 listed)
- Use of alcohol, cigarettes or illegal drugs
- Pregnancy complications
- Unable or unwilling to breastfeed
- Excessive or insufficient weight gain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise | Behavioural | Exercise |
Primary outcome
Mismatch negativity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2010.
- Derived from this study: PubMed 22643160LeMoyne 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elise L.LeMoyne principal investigator
Université de Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Pregnancy, run by Université de Montréal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elise L. LeMoyne (514-343-6111 ext. 5380, apgrossesse@kinesio.umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mismatch negativity. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01220778, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2010.