Aerobic Training in Pregnant Women With Gestational Diabetes and Chronic Hypertension

NCT01885234 | Completed

• 1 other identifier: GDM-HAS120008
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pregnancy; Gestational Diabetes Mellitus; Chronic Hypertension in Obstetric Context

Keywords

Glycated hemoglobin; HOMA; Pregnancy; aerobic exercise

Outcome Measures

Primary Outcomes (1)

• glycated hemoglobin

  day 1 and 10 weeks after training

Secondary Outcomes (1)

• HOMA

  day 1 and 10 weeks after training

Other Outcomes (1)

• First ventilatory threshold

  day 1 and 10 weeks after training

Study Arms (2)

Aerobic exercise

EXPERIMENTAL

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

Stretch exercise

PLACEBO COMPARATOR

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

Aerobic exercise OTHER

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

Aerobic exercise

Stretch exercise OTHER

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

Stretch exercise

Eligibility Criteria

• Age: 20 Weeks - 27 Weeks
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Exercise; Plyometric Exercise

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human

Study Officials

• José Geraldo L Ramos, MD

  HC Porto Alegre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2013
• First Posted: June 24, 2013
• Study Start: December 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 22, 2015

Record last verified: 2015-12

Locations

BR (1)