NCT02392741

Brief Summary

This study aims to determine the effect of a physical exercise program on microcirculation and maternal and perinatal outcomes in obese women. A randomized clinical trial will be performed at IMIP with obese pregnant women assisted at the Instituto de Medicina Integral Professor Fernando Figueira (IMIP) prenatal service.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Mar 2015

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2015

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 19, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

March 19, 2015

Status Verified

March 1, 2015

Enrollment Period

9 months

First QC Date

February 25, 2015

Last Update Submit

March 18, 2015

Conditions

ObesityPregnancy

Keywords

Physical ActivityMicrocirculationPregnancy OutcomeObesityPregnancy

Outcome Measures

Primary Outcomes (1)

  • Effects on microcirculation

    Microcirculation will be assessed using the Laser-doppler flowmetry manufacturers software (Moor Instruments, UK) and expressed in perfusion units (PU). The parameters that will be used to evaluate the microcirculation (microvascular function) are: resting skin blood flux (RF), maximum skin blood flux (MF) at peak PORH, the ratio of maximum level and flow at rest (MF/RF) and the area of hyperemia (AH) which is the graphical area under the curve formed during PORH.

    change from baseline microcirculation after 8 weeks

Secondary Outcomes (14)

  • Gestational diabetes

    at 30 weeks gestation

  • Gestational hypertension

    at 30 weeks gestation

  • Preeclampsia

    at 30 weeks gestation

  • Weight gain

    at admission on the study and till 40 weeks gestation

  • Gestational age at delivery

    at delivery

  • +9 more secondary outcomes

Study Arms (2)

Control

NO INTERVENTION

The control group will follow the IMIP prenatal routine.

Physical exercise program

EXPERIMENTAL

The intervention group witch will be submitted to an exercise program consisting of daily post prandial, 10' after breakfast, lunch and dinner.

Other: Physical exercise program

Interventions

Physical exercise programOTHER

The intervention consists to an exercise program composed by a daily post prandial, 10' after breakfast, lunch and dinner, totaling 150' weekly, for eight weeks.

Also known as: Walking
Physical exercise program

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Singleton pregnancy between 14 and 20 weeks gestation;
  • Literate women;
  • sedentary lifestyle.

You may not qualify if:

  • Cognitive, auditory, visual or motor impairment, certified by a specialist;
  • Any pregnancy disorders or previous maternal diseases: diabetes type 1 or type 2, hypertensive disorders of pregnancy, hemodynamic instability, renal disease or collagen, vaginal bleeding;
  • Any medical or obstetric contraindication to perform physical activity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ObesityMotor Activity

Interventions

Walking

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

LocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Study Officials

  • José Roberto da Silva Junior, Master

    Professor Fernando Figueira Integral Medicine Institute

    STUDY DIRECTOR

  • Isabelle Eunice de Albuquerque Pontes, Master

    Professor Fernando Figueira Integral Medicine Institute

    STUDY CHAIR

  • João Guilherme Bezerra Alves, PhD

    Professor Fernando Figueira Integral Medicine Institute

    PRINCIPAL INVESTIGATOR

  • Karine Ferreira Agra, Master

    Professor Fernando Figueira Integral Medicine Institute

    STUDY CHAIR

Central Study Contacts

João Guilherme Bezerra Alves, PhD

CONTACT

+55 81 21224122joaoguilherme@imip.org.br

Karine Ferreira Agra, Master

CONTACT

+55 81 21224122karine_agra@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Master in Health

Study Record Dates

First Submitted

February 25, 2015

First Posted

March 19, 2015

Study Start

March 1, 2015

Primary Completion

December 1, 2015

Study Completion

March 1, 2017

Last Updated

March 19, 2015

Record last verified: 2015-03