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

NCT ID: NCT01477372

Last Updated: 2012-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2011-02-28

Brief Summary

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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

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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).

Conditions

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Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exercise group

Supervised exercise program

Group Type EXPERIMENTAL

Supervised exercise program

Intervention Type 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

Control

Sedentary pregnant woman

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad Politecnica de Madrid

OTHER

Sponsor Role lead

Responsible Party

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Ruben Barakat Carballo

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ruben O Barakat, PhD

Role: STUDY_DIRECTOR

Universidad Politecnica de Madrid

Mireia Peláez, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad Politecnica de Madrid

Locations

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Universitarian Hospital of Fuenlabrada

Fuenlabrada, Madrid, Spain

Site Status

Countries

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Spain

References

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Pelaez M, Gonzalez-Cerron S, Montejo R, Barakat R. Protective Effect of Exercise in Pregnant Women Including Those Who Exceed Weight Gain Recommendations: A Randomized Controlled Trial. Mayo Clin Proc. 2019 Oct;94(10):1951-1959. doi: 10.1016/j.mayocp.2019.01.050.

Reference Type DERIVED
PMID: 31585579 (View on PubMed)

Other Identifiers

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240/09

Identifier Type: -

Identifier Source: org_study_id

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