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
  Purpose

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


Condition Intervention
Pregnancy
Behavioral: Supervised exercise program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Physical Exercise Program During Pregnancy on Excessive Weight Gain and Its Consequences

Resource links provided by NLM:


Further study details as provided by Universidad Politecnica de Madrid:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Enrollment: 320
Study Start Date: September 2007
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise group
Supervised exercise program
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
No Intervention: Control
Sedentary pregnant woman

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).

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01477372

Locations
Spain
Universitarian Hospital of Fuenlabrada
Fuenlabrada, Madrid, Spain, 28942
Sponsors and Collaborators
Universidad Politecnica de Madrid
Investigators
Study Director: Ruben O Barakat, PhD Universidad Politécnica de Madrid
Principal Investigator: Mireia Peláez, PhD Universidad Politécnica de Madrid
  More Information

No publications provided

Responsible Party: Ruben Barakat Carballo, Director, Universidad Politecnica de Madrid
ClinicalTrials.gov Identifier: NCT01477372     History of Changes
Other Study ID Numbers: 240/09
Study First Received: September 22, 2011
Last Updated: April 10, 2012
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Universidad Politecnica de Madrid:
Pregnancy
Exercise
Excessive weight gain
Outcomes
Urinary incontinence

Additional relevant MeSH terms:
Weight Gain
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 21, 2014