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CompletedNCT01885234Updated Dec 22, 2015

Aerobic Training in Pregnant Women With Gestational Diabetes and Chronic Hypertension

An interventional study of Aerobic exercise and Stretch exercise in Pregnancy, Gestational Diabetes Mellitus and Chronic Hypertension in Obstetric Context, sponsored by Hospital de Clinicas de Porto Alegre. Completed at 1 site in Brazil. Open to female participants aged 20 Weeks to 27 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-12-22.

Sponsored by Hospital de Clinicas de Porto Alegre · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
9
Allocation
Randomized
Ages
20 Weeks to 27 Weeks
Sex
Female
01

Study summary

The aim of the present study is verify glycated hemoglobin (HbA1c) and HOMA behavior in pregnant women with gestational diabetes or chronic hypertension after an aerobic training in cycle-ergometer. The sample is composed by 64 pregnant and sedentary women, 20 weeks' pregnant.

Two experimental groups (gestational diabetes and chronic hypertension, n = 16 each) will perform a low-intensity aerobic training in cycle-ergometer, three times/week, for 45 minutes each session. Two control groups (gestational diabetes and chronic hypertension, n = 16 each) will perform an unique session/week of relaxation and stretching.

Outcomes: first ventilatory threshold, HbA1c,HOMA, type of delivery, weight and height of the newborn.

Read the detailed description

The statistical analysis will consist of:

  • descriptive statistic;
  • Levene's test
  • Shapiro Wilk's normality test
  • Parametric or non-parametric test
  • a=0.05
  • SPSS 17.0
02

Conditions studied

  • Pregnancy
  • Gestational Diabetes Mellitus
  • Chronic Hypertension in Obstetric Context

Keywords

  • Glycated hemoglobin
  • HOMA
  • Pregnancy
  • aerobic exercise
03

In context

Diabetes, Gestational

842 studies on the registry are indexed under Diabetes, Gestational; 198 are open to participants now.

This study's enrollment of 9 is below the median of 110 across 550 interventional studies indexed under Diabetes, Gestational.

Browse Diabetes, Gestational studies →

Lead sponsor

Hospital de Clinicas de Porto Alegre is the lead sponsor of 450 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Weeks to 27 Weeks
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • age > 20 years;
  • gestational age between 20 and 27 weeks (date of the last period and confirmed by ultrasound);
  • Only one foetus in the womb;
  • Without orthopedic limitations;
  • Non-smoker;
  • Medical clearance for exercise

Exclusion criteria

Exclusion Criteria:

  • Pre-eclampsia;
  • fetal malformations;
  • Intrauterine fetal death
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
9 participants (actual)

Study arms

  • Experimental
    Aerobic exercise

    Pregnant women with Gestational Diabetes and pregnant women with chronic hypertension will perform 50 minutes of aerobic exercise in a bicycle, 3 times a week

    Other: Aerobic exercise

  • Placebo comparator
    Stretch exercise

    Pregnant women with Gestational Diabetes and pregnant women with chronic hypertension will perform 50 minutes of stretch exercise, once a week

    Other: Stretch exercise

Interventions

  • OtherAerobic exercise

    Pregnant women with Gestational Diabetes and pregnant women with chronic hypertension will perform 50 minutes of aerobic exercise in a bicycle, 3 times a week

  • OtherStretch exercise

    Pregnant women with Gestational Diabetes and pregnant women with chronic hypertension will perform 50 minutes of stretch exercise, once a week

06

What researchers measure

Primary outcomes

  1. glycated hemoglobin

    Time frame: day 1 and 10 weeks after training

Secondary outcomes

  1. HOMA

    Time frame: day 1 and 10 weeks after training

Other outcomes

  1. First ventilatory threshold

    Time frame: day 1 and 10 weeks after training

07

Study locations

1 site
  • Hospital de Clínicas de Porto Alegre
    Porto Alegre, RS 90035-903, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 22, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01885234
Lead sponsor
Hospital de Clinicas de Porto Alegre
Responsible party
Sponsor
First posted
Jun 24, 2013
Start date
Dec 2011
Primary completion
Dec 2015
Completion
Dec 2015
Last update
Dec 22, 2015

Study contacts

José Geraldo L Ramos, MD
principal investigator · HC Porto Alegre

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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