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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01477372
• Other study ID #: 240/09
• Status: Completed
• Phase: N/A
• First received: September 22, 2011
• Last updated: April 10, 2012
• Start date: September 2007
• Est. completion date: February 2011

Study information

• Verified date: April 2012
• Source: Universidad Politecnica de Madrid
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pregnancy
• Weight Gain

Intervention

Behavioral:
• Supervised exercise program
Intervention group participated in Blooming Exercise Program as from week 10-12 of gestation. At least 56 sessions through 22 weeks. 3 sessions per week

Locations

Country	Name	City	State
Spain	Universitarian Hospital of Fuenlabrada	Fuenlabrada	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Politecnica de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal weight gain	Maternal weight gain and proportion of participants exceeding weight gain above IOM (2009) recommendations	week 36-38 of gestation	No
Secondary	Excessive weight gain related risks (gestational diabetes, macrosomia, type of delivery)		week 36-38 of gestation	No
Secondary	Urinary incontinence		week 36-38 of gestation	No
Secondary	Other pregnancy outcomes (maternal and foetal)		week 36-38 of gestation	No