Diabetes, Gestational Clinical Trial
Official title:
Acute Effects of an Aquatic Physical Exercise on Glycemic Control of Gestational Diabetes
NCT number | NCT02931656 |
Other study ID # | 1111-1188-1100 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2016 |
Est. completion date | June 2019 |
Verified date | October 2019 |
Source | Professor Fernando Figueira Integral Medicine Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Gestational diabetes mellitus (GDM) is increasing worldwide and has been associated with adverse perinatal outcomes and high risk for chronic disease both for the mother and for the child. Physical exercise is feasible to diabetic pregnant women and contributes to a better glycemic control and to decrease adverse perinatal outcomes. However there are no studies assessing the effects of aquatic physical exercise on GDM control.
Status | Completed |
Enrollment | 70 |
Est. completion date | June 2019 |
Est. primary completion date | December 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 35 Years |
Eligibility |
Inclusion Criteria: - GDM Group: GDM diagnosis will be based on International Association of the Diabetes in Pregnancy Study Group (IADPSG) and WHO, Hyperglycemia and Adverse Pregnancy Outcomes (HAPO) study (2 h 75 g oral glucose tolerance test (OGTT): a fasting glucose = 92 mg/dl or a one hour result of = 80 mg/dl, or a two hour result of = 153 mg/dl; - Control Group: Normal glucose tolerance (IADPSG /WHO) - Aging 18 to 35 years; - Physically inactive (< 150` per week based on International Physical Activity Questionnaire. Exclusion Criteria: - Kidney disease or collagenosis; - Previous history of gestational diabetes; - Diabetes type 1 or type 2; - Hypertensive disorders related to pregnancy; - Hemodynamic instability; - Obstetric labor; - Vaginal bleeding; - Cognitive disorder, auditory, visual or motor severely limiting, attested by a medical specialist; - Skin disorders who have a contraindication to the use of a swimming pool; - Urinary tract infection; - Be inserted in the program of regular exercise; |
Country | Name | City | State |
---|---|---|---|
Brazil | José Roberto da Silva Junior | Recife | Pernambuco |
Lead Sponsor | Collaborator |
---|---|
Professor Fernando Figueira Integral Medicine Institute | Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Fundação de Amparo à Ciência e Tecnologia do Estado de Pernambuco |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from Glycemic level | Blood glucose test: maternal glucose levels | Before and up to 5 minutes after the intervention | |
Secondary | Change from Systolic and diastolic blood pressure | Measured in mmHg every medical consultation | Before and up to 5 minutes after the intervention | |
Secondary | Change from Heart rate (pulse) | number of beats in 60 seconds | Before and up to 5 minutes after the intervention | |
Secondary | Change from Respiratory rate | number of movements indicative of inspiration and expiration per 60 seconds | Before and up to 5 minutes after the intervention | |
Secondary | Change from Oxygen saturation | Quantity oxygen is being transported in the blood at the time of measurement | Before and up to 5 minutes after the intervention | |
Secondary | Change from Fetal heart rate | Heartbeat frequency of the fetus per minute | Before and up to 5 minutes after the intervention |
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