Effect of Physical Exercise Program During Pregnancy on Excessive Weight Gain and Its Consequences

Not Applicable

Completed

• Conditions: Pregnancy
• Interventions: Behavioral: Supervised exercise program

• Registration Number: NCT01477372
• Lead Sponsor: Universidad Politecnica de Madrid

Brief Summary

The purpose of this study was to assess the effectiveness of a moderated physical exercise program called Blooming Exercise Program (BEP) developed during pregnancy in order to control excessive maternal weight gain and its consequences. Additionally, other objectives of the study were to analyse the influence of BEP on urinary incontinence, on the other pregnancy outcomes and on the perception of the pregnant's health

Detailed Description

BACKROUND: Pregnancy and delivery can condition significantly women's health. In particular, an excessive gain of weight during pregnancy constitutes a risk factor which may lead to (i) different alterations during pregnancy such as gestational diabetes or hypertension, (ii) foetus health problems (macrosomia), (iii) delivery complications (dystocia, prolonged labour and increased number of caesareans) and (iv) future health disorders for the woman (overweight, obesity and cardiovascular alterations). Furthermore, during pregnancy pelvic floor health problems, such as urinary incontinence (IU) may arise or worsen.

OBJECTIVES: The main aim of this study was to assess the effectiveness of a moderate physical exercise program called Blooming Exercise Program (BEP) developed during pregnancy in order to control excessive maternal weight gain and its consequences. Additionally, other objectives of the study were to analyse the influence of BEP on urinary incontinence, on the other pregnancy outcomes (maternal and foetal) and on the perception of the pregnant's health.

DESIGN: A randomized, controlled trial called has been conducted. 300 healthy pregnant women were recruited and divided into an intervention group (IG, n=100) and a control group (CG, n=200). The IG participated in BEP as from week 10-12 of gestation (at least 56 sessions through 22 weeks. 3 sessions per week). The CG did not participate in any supervised program addressed to pregnant women but received regular health care. Pregnancy outcomes regarding the mother and the new born, urinary incontinence and women's habits data were obtained and registered through initial interviews, medical records and two specific questionnaires on health and urinary incontinency (ICIQ-SF and King's).

Study Timeline

• Study Start: 2007-09
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Study First Submitted: 2011-09-22
• Study First Submitted QC: 2011-11-18
• Study First Posted: 2011-11-22
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-10
• Last Update Posted: 2012-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 320

Inclusion Criteria

• Healthy pregnant women
• Delivering in "Hospital Universitario de Fuenlabrada"
• At week 10-14 of gestation
• Able to attend 3 sessions per week until the end of the pregnancy

Exclusion Criteria

• Contraindications appointed by ACOG
• Less than 56 sessions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise group	Supervised exercise program	Supervised exercise program

Primary Outcome Measures

Name	Time	Method
Maternal weight gain	week 36-38 of gestation	Maternal weight gain and proportion of participants exceeding weight gain above IOM (2009) recommendations

Secondary Outcome Measures

Name	Time	Method
Excessive weight gain related risks (gestational diabetes, macrosomia, type of delivery)	week 36-38 of gestation
Urinary incontinence	week 36-38 of gestation
Other pregnancy outcomes (maternal and foetal)	week 36-38 of gestation

Trial Locations

Locations (1)

Universitarian Hospital of Fuenlabrada; 🇪🇸 Fuenlabrada, Madrid, Spain