Acute Effects of an Aquatic Physical Exercise on Glycemic Control of Gestational Diabetes

NCT02931656 | Completed DMC

• 1 other identifier: 1111-1188-1100
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes, Gestational

Keywords

Gestational Diabetes

Outcome Measures

Primary Outcomes (1)

• Change from Glycemic level

  Blood glucose test: maternal glucose levels

  Before and up to 5 minutes after the intervention

Secondary Outcomes (5)

• Change from Systolic and diastolic blood pressure

  Before and up to 5 minutes after the intervention

• Change from Heart rate (pulse)

  Before and up to 5 minutes after the intervention

• Change from Respiratory rate

  Before and up to 5 minutes after the intervention

• Change from Oxygen saturation

  Before and up to 5 minutes after the intervention

• Change from Fetal heart rate

  Before and up to 5 minutes after the intervention

Study Arms (2)

GDM aquatic exercise

EXPERIMENTAL

GDM Diagnosis criteria accordance with to IADPSG / WHO

Other: Aquatic exercise

Control Group aquatic exercise

ACTIVE COMPARATOR

No change in blood glucose levels Group, investigated between 24-28 weeks of gestation.

Other: Aquatic exercise

Interventions

Aquatic exercise OTHER

The aquatic exercise program will be under the professional guidance of a physiotherapist, with water at a temperature of around 26 to 28°C. The exercise sessions will be executed following the steps: 1) Heating (stretching and flexibility, static method, during 5'); 2) Aerobic exercise (running, displacements and combined movements of arms and legs, with 1minute interval, to 1minute activity and of during 20') 3) Spot exercises (strength / endurance of the upper and lower limbs and abdomen, using the resistance of water for 15') 4) Relaxation (slow walks for 5'). During the sessions of exercises the pregnant women will have heart rate monitored by the frequency meter (Polar Electro OY) to control the intensity of the exercises that will focus on the range of moderate intensity.

Also known as: Water aerobics, Hydrotherapy

Control Group aquatic exercise; GDM aquatic exercise

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Professor Fernando Figueira Integral Medicine Institute: lead
• Fundação de Amparo à Ciência e Tecnologia de Pernambuco: collaborator
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator

Study Sites (1)

José Roberto da Silva Junior

Recife, Pernambuco, 50070-550, Brazil

Location

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Aquatic Therapy; Hydrotherapy

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)

Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Officials

• João Guilherme Bezerra Alves/, Doctor

  Institute of Integrative Medicine Professor Fernando Figueira

  STUDY DIRECTOR

• Alex Sandro Rolland de Souza, Doctor

  Institute of Integrative Medicine Professor Fernando Figueira

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Fernando Figueira Integral Medicine Institute

Study Record Dates

• First Submitted: September 28, 2016
• First Posted: October 13, 2016
• Study Start: March 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: June 1, 2019
• Last Updated: October 9, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)