Effect of Physical Exercise Program During Pregnancy on E... | NCT01477372

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

NCT01477372

Sponsor

Universidad Politecnica de Madrid

Status

Completed

Last Update Posted

Apr 11, 2012Estimated

Enrollment

320Actual

Phase

Not Applicable

Conditions

Pregnancy

Interventions

Supervised exercise program

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2007

Primary Completion Date

Feb 2011Actual

Completion Date

Feb 2011Actual

First Submitted Date

Sep 22, 2011

First Submission Date that Met QC Criteria

Nov 18, 2011

First Posted Date

Nov 22, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 10, 2012

Last Update Posted Date

Apr 11, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ruben Barakat Carballo, Director, Universidad Politecnica de MadridPrincipal Investigator

Lead Sponsor

Universidad Politecnica de MadridOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

320Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Exercise group	Experimental	Supervised exercise program	Behavioral: Supervised exercise program
Control	No Intervention	Sedentary pregnant woman

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maternal weight gain	Maternal weight gain and proportion of participants exceeding weight gain above IOM (2009) recommendations	week 36-38 of gestation

Secondary Outcomes

Measure	Description	Time Frame
Excessive weight gain related risks (gestational diabetes, macrosomia, type of delivery)		week 36-38 of gestation
Urinary incontinence		week 36-38 of gestation

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ruben O Barakat, PhD	Universidad Politecnica de Madrid	Study Director
Mireia Peláez, PhD	Universidad Politecnica de Madrid	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universitarian Hospital of Fuenlabrada		Fuenlabrada	Madrid	28942	Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31585579	Derived	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.

ID	Term
D009043	Motor Activity
D014549	Urinary Incontinence

ID	Term
D001519	Behavior
D014555	Urination Disorders
D014570	Urologic Diseases
D052776	Female Urogenital Diseases