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Completed

NCT Number: NCT01477372

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

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Key information

Conditions

Pregnancy Behavior Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Motor Activity Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Universitarian Hospital of Fuenlabrada

Fuenlabrada, Madrid, 28942, Spain

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Supervised exercise program

Behavioral

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

Primary outcomes

  1. Maternal weight gain

    Time frame: week 36-38 of gestation

    Maternal weight gain and proportion of participants exceeding weight gain above IOM (2009) recommendations

Secondary outcomes

  1. Excessive weight gain related risks (gestational diabetes, macrosomia, type of delivery)

    Time frame: week 36-38 of gestation

  2. Urinary incontinence

    Time frame: week 36-38 of gestation

  3. Other pregnancy outcomes (maternal and foetal)

    Time frame: week 36-38 of gestation

Sponsors and collaborators

Lead sponsor

Universidad Politecnica de Madrid

Other

Registry information

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Nov 22, 2011
Registry last updated
Apr 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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