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Acute Maternal and Fetal Effects of Exercise in Pregnancy

NCT01383889 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2013-03-05

No results posted yet for this study

Summary

This will be an open randomized clinical trial involving pregnant women between 35 and 37 weeks randomized to two modalities of exercise: treadmill or stationary bike. The study hypothesis is that exercise on a stationary cycle causes less maternal and fetal effects in relation to treadmill exercise.We will study the acute effects of exercise for both the mother and the fetus, monitoring the parameters before, during and after exercise for 20 minutes. The exercise intensity will be moderate, remaining between 60% and 80% of maximum heart rate. Women will be monitored with a recording equipment of ABPM (ambulatory blood pressure monitorization) and continuous cardiotocography and blood will be collected to measure blood glucose, total cholesterol and HDL, nitrate and lactate before, during and after exercise. The analysis variables are: maternal heart rate and blood pressure, fetal heart rate, number of fetal movements, transient accelerations, decelerations, short-term variability, episodes of high variability, uterine tone, glucose, lactate, nitrate, total cholesterol and HDL.The analysis will be based on intention to treat, according to the recommendations of the CONSORT (2010).

Conditions

  • Blood Pressure
  • Heart Rate and Rhythm Disorders
  • Hypoglycemia
  • Lactate
  • Nitrate
  • Cholesterol (Total and HDL)
  • Abnormality in Fetal Heart Rate or Rhythm, Unspecified as to Episode of Care

Interventions

OTHER

Physical exercise

Two modalities of exercise will be compared: treading mill and stationary bicycle. Pregnant women enrolled in the study will perform exercise during 20 minutes and will be monitored 20 minutes before, during and 20 minutes after exercise.

Sponsors & Collaborators

  • Professor Fernando Figueira Integral Medicine Institute

    collaborator OTHER

  • Federal University of Paraíba

    collaborator OTHER

  • Instituto Materno Infantil Prof. Fernando Figueira

    lead OTHER

Principal Investigators

  • Melania MR Amorim, MD, PhD · Instituto Materno Infantil Prof. Fernando Figueira

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01383889 on ClinicalTrials.gov