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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ruben Barakat Carballo, Universidad Politecnica de Madrid
ClinicalTrials.gov Identifier:
NCT01477372
First received: September 22, 2011
Last updated: April 10, 2012
Last verified: April 2012

September 22, 2011
April 10, 2012
September 2007
February 2011   (final data collection date for primary outcome measure)
Maternal weight gain [ Time Frame: week 36-38 of gestation ] [ Designated as safety issue: No ]
Maternal weight gain and proportion of participants exceeding weight gain above IOM (2009) recommendations
Same as current
Complete list of historical versions of study NCT01477372 on ClinicalTrials.gov Archive Site
  • Excessive weight gain related risks (gestational diabetes, macrosomia, type of delivery) [ Time Frame: week 36-38 of gestation ] [ Designated as safety issue: No ]
  • Urinary incontinence [ Time Frame: week 36-38 of gestation ] [ Designated as safety issue: No ]
  • Other pregnancy outcomes (maternal and foetal) [ Time Frame: week 36-38 of gestation ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of Physical Exercise Program During Pregnancy on Excessive Weight Gain and Its Consequences
Effect of Physical Exercise Program During Pregnancy on Excessive Weight Gain and Its Consequences

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

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).

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Pregnancy
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
  • Experimental: Exercise group
    Supervised exercise program
    Intervention: Behavioral: Supervised exercise program
  • No Intervention: Control
    Sedentary pregnant woman
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
320
February 2011
February 2011   (final data collection date for primary outcome measure)

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
Female
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01477372
240/09
No
Ruben Barakat Carballo, Universidad Politecnica de Madrid
Universidad Politecnica de Madrid
Not Provided
Study Director: Ruben O Barakat, PhD Universidad Politécnica de Madrid
Principal Investigator: Mireia Peláez, PhD Universidad Politécnica de Madrid
Universidad Politecnica de Madrid
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP