Trial record 13 of 293 for:    child [AGE-GROUP] AND exercise [TREATMENT] | Open Studies

Aerobic Training in Pregnant Women With Gestational Diabetes and Chronic Hypertension

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Hospital de Clinicas de Porto Alegre
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT01885234
First received: June 5, 2013
Last updated: June 19, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Pregnancy
Gestational Diabetes Mellitus
Chronic Hypertension in Obstetric Context
Other: Aerobic exercise
Other: Stretch exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Health Services Research
Official Title: Aerobic Training Effect in Pregnant Women With Gestational Diabetes and Chronic Hypertension: Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:
  • glycated hemoglobin [ Time Frame: day 1 and 10 weeks after training ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • HOMA [ Time Frame: day 1 and 10 weeks after training ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • First ventilatory threshold [ Time Frame: day 1 and 10 weeks after training ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 128
Study Start Date: December 2011
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
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
Pregnant women with Gestational Diabetes and pregnant women with chronic hypertension will perform 50 minutes of stretch exercise, once a week

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
  Eligibility

Ages Eligible for Study:   20 Weeks to 27 Weeks
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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:

  • Pre-eclampsia;
  • fetal malformations;
  • Intrauterine fetal death
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01885234

Contacts
Contact: José Geraldo L Ramos, MD ramosjg@terra.com.br
Contact: Roberta Bgeginski, MSc robertabg@gmail.com

Locations
Brazil
Hospital de Clínicas de Porto Alegre Recruiting
Porto Alegre, RS, Brazil, 90035-903
Contact: José Geraldo L Ramos, MD       ramosjg@terra.com.br   
Principal Investigator: José Geraldo L Ramos, MD         
Sub-Investigator: Sérgio H Martins-Costa, MD         
Sub-Investigator: Maria Lúcia R Oppermann, MD         
Sub-Investigator: Roberta Bgeginski, MSc         
Sub-Investigator: Luiz Fernando M Kruel, PhD         
Sub-Investigator: Felipe Schuch, MSc         
Sub-Investigator: Rodrigo S Delevatti, MSc         
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
Principal Investigator: José Geraldo L Ramos, MD HC Porto Alegre
  More Information

No publications provided

Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT01885234     History of Changes
Other Study ID Numbers: GDM-HAS120008
Study First Received: June 5, 2013
Last Updated: June 19, 2013
Health Authority: Brazil: Associação Fundo de Incentivo à Pesquisa
Brazil: Ethics Committee
Brazil: National Committee of Ethics in Research

Keywords provided by Hospital de Clinicas de Porto Alegre:
Glycated hemoglobin
HOMA
Pregnancy
aerobic exercise

Additional relevant MeSH terms:
Diabetes Mellitus
Hypertension
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Pregnancy Complications

ClinicalTrials.gov processed this record on August 27, 2014