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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01610323
Other study ID # SC11-05-021-21
Secondary ID
Status Completed
Phase N/A
First received May 31, 2012
Last updated July 25, 2014
Start date October 2011
Est. completion date July 2014

Study information

Verified date July 2014
Source Centre Hospitalier Universitaire de Québec, CHU de Québec
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial Summary

In pregnancy, the adoption or pursuit of a sedentary lifestyle contributes to the development of co-morbid conditions such as hypertension, maternal and childhood obesity, gestational diabetes, pre-eclampsia, cesarean section and delivery of large-for-gestational-age infants (LGA).

The aim of this study is to test the hypothesis that obese, pregnant women following a supervised moderate intensity physical conditioning program during the 2nd trimester of pregnancy will maintain a higher level of physical activity up to the end of pregnancy, as compared to women in the control group. We will also conduct a pilot study on the feasibility to examine the effects of the intervention on maternal fitness and neonatal anthropometry.


Description:

Looking at the multiple needs of pregnant women with obesity, physical conditioning may offer a great opportunity to improve fitness and to decrease cardio-metabolic disturbances, to prevent excessive weight gain, to improve general health status, and to reduce health care utilization. Furthermore, beneficial effects of fitness on adverse maternal health outcomes related to obesity might decrease the development of long-term obesity and metabolic repercussions in the offspring.

The Society of Obstetricians and Gynaecologists of Canada (SOGC) recommends that all women without contraindication be encouraged to participate in aerobic and strength-conditioning exercises as part of a healthy lifestyle during pregnancy. Despite these recommendations, obese women are inactive during pregnancy and are currently still at high risk of poor physical fitness.

Thus, although exercise clearly improves maternal health status and thus potentially prevents adverse perinatal outcomes, obese pregnant women poorly adhere to experts' recommendations about the need for exercise during pregnancy. Therefore, this situation justifies the need to develop adapted strategies aimed at increasing the implementation of guideline recommendations in this population.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date July 2014
Est. primary completion date June 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- pregnant women 18 years or older

- single pregnancy

- delivery at Centre Hospitalier Universitaire de Québec

- pre-pregnancy BMI =30 kg/m2

Exclusion Criteria:

- multiple pregnancy

- diabetes or chronic hypertension prior to pregnancy

- uncontrolled thyroid problems

- exercise contraindications

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Other:
Exercise intervention
Exercise group: 12 weeks of moderate intensity physical training under individual supervision in a specialised conditioning center, with a goal of 3 1h-sessions/week (from 16 wks to 28 wks of gestation). Including aerobic and muscular training.
Standard Care


Locations

Country Name City State
Canada Centre Hospitalier Universitaire de Québec Quebec

Sponsors (2)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Québec, CHU de Québec Fondation des étoiles

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Weekly time spent at physical activity of moderate intensity and above Accelerometry data (minutes per week spent over selected cutpoints) At 36 weeks of gestation No
Secondary Gestational weight gain Weight in kg at 36 weeks - weight in kg at 14 weeks At 36 weeks of gestation No
Secondary Muscular fitness Endurance and strength of lower and upper limbs as assessed by an isokinetic dynamometer. At 28 wks of gestation No
Secondary Cardiorespiratory fitness O2 consumption (ml*kg-1*min-1) at the anaerobic threshold. At 28 weeks of gestation No
Secondary Energy Expenditure According to the Pregnancy Physical Activity Questionnaire (PPAQ) At 36 weeks of gestation No
Secondary Neonatal anthropometry Birth weight, length and skinfolds At delivery No
Secondary Fetal growth Ultrasound and doppler At 28 weeks of gestation No
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