NCT01383889

Brief 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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2011

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 28, 2011

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

March 5, 2013

Status Verified

March 1, 2013

Enrollment Period

1 year

First QC Date

June 27, 2011

Last Update Submit

March 4, 2013

Conditions

Blood PressureHeart Rate and Rhythm DisordersHypoglycemiaLactateNitrateCholesterol (Total and HDL)Abnormality in Fetal Heart Rate or Rhythm, Unspecified as to Episode of Care

Keywords

Physical exercisePregnancyFetal well being

Outcome Measures

Primary Outcomes (1)

  • Fetal bradycardia

    Fetal heart rate will be monitored durante 60 minutes, 20 minutes before, 20 minutes during and 20 minutes after two modalities of exercise: treading mill and stationary bicycle. The frequency of fetal bradycardia will be assessed.

    60 minutes

Secondary Outcomes (8)

  • Maternal blood pressure

    60 minutes

  • Maternal heart rate

    60 minutes

  • Glycemia

    60 minutes

  • Maternal lactate

    60 minutes

  • Maternal nitrate

    60 minutes

  • +3 more secondary outcomes

Study Arms (2)

Treading mill exercise

OTHER

Pregnant women in this group will perform treadmill exercise during 20 minutes. The intensity of exercise will be maintained between 60% and 80% of maximum heart rate by Karvonen formula, in addition to the subjective perception of exertion on the modified Borg scale (moderate intensity).

Other: Physical exercise

Stationary bicycle exercise

OTHER

Pregnant women in this group will perform exercise using a stationary bicycle. The intensity of exercise will be maintained between 60% and 80% of maximum heart rate by Karvonen formula, in addition to the subjective perception of exertion on the modified Borg scale (moderate intensity).

Other: Physical exercise

Interventions

Physical exerciseOTHER

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.

Stationary bicycle exerciseTreading mill exercise

Eligibility Criteria

Age20 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Single pregnancy
  • Alive fetus
  • Gestational age between 35 and 37 weeks
  • Previous sedentarity

You may not qualify if:

  • Smoking
  • Chronic maternal illness
  • Diseases that affect respiratory capacity
  • Physical handicap precluding performing exercise
  • Arterial Hypertension
  • Diabetes in Pregnancy
  • Placenta praevia
  • Preterm labor
  • Bleeding in the third trimester
  • Fetal Growth Restriction
  • Oligo-hydramnios
  • Brain-sparing effect
  • Fetal malformations
  • Medical contraindications for performing exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Paraibano de Pesquisa Prof. Joaquim Amorim Neto

Campina Grande, Paraíba, 58406120, Brazil

Location

MeSH Terms

Conditions

HypoglycemiaMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Melania MR Amorim, MD, PhD

    Instituto Materno Infantil Prof. Fernando Figueira

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 27, 2011

First Posted

June 28, 2011

Study Start

December 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

March 5, 2013

Record last verified: 2013-03

Locations

BR(1)