Effects of Exercise During Gestation on Maternal and Foetal Health (GESTAFIT)

University of Granada (UGR)

Status: Completed

Conditions: Pregnancy

Treatments: Other: Control group; Other: Exercise intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02582567

GESTAFIT

Details and patient eligibility

About

The main objective of this project is to assess the effects of a novel and supervised exercise intervention in overweight pregnant and their newborn.

Methods/Design: The present study is a Randomized Controlled Trial. Sixty overweight pregnant interested in participate in the intervention program will be randomly assigned to either exercise (3 sessions/week), or to usual care (control) group (30 pregnant per group). The primary outcome measures are maternal weight gain, and maternal and neonatal glycaemic profile. Secondary outcomes measure are: i) body composition; ii) dietary patterns; iii) physical fitness; iv) objectively measured physical activity and sedentary behaviour; v) sleep quality; vi) mental health, quality of life and positive health; vii) haematology and biochemical analysis; viii) oxidative stress; ix) pro- and anti-inflammatory markers; x) bone health biomarkers; xi) adiposity-related proteins expression. The data will be analysed on an intention-to-treat basis and per protocol.

Enrollment: 140 patients

Sex: Female

Ages: 25 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Overweight pregnant woman with a normal pregnancy course.
• Answer "no" to all questions on the PARmed-X for pregnancy*.
• To be able to walk without assistance.
• To be able to read and write enough.
• Informed consent: To be capable and willing to provide consent. *In addition, specific inclusion criteria for data analysis are: gestational age at delivery of 37-42 weeks with single foetus, spontaneous vaginal delivery or instrumental vaginal and caesarean without maternofoetal pathology (or other indication that does not involve maternofoetal risk, such as disproportion, failed induction, no foetal progression or non-cephalic presentation), newborn with appropriate weight, Apgar score>7 in the 1st and 5th minute of life, cord blood pH (normal>7.20) and normal monitoring results.

Exclusion criteria

• Acute or terminal illness.
• Malnutrition.
• Inability to conduct tests for assessing physical fitness or exercise during pregnancy.
• Underweight, normal-weight or obesity.
• Pregnancy risk factors (such as hypertension, type 2 diabetes, etc.).
• Multiple pregnancies.
• Chromosopathy or foetal malformations.
• Uterine growth restriction.
• Foetal death.
• Upper or lower extremity fracture in the past 3 months.
• Presence of neuromuscular disease or drugs affecting neuromuscular function
• Be registered in other exercise program
• Perform more than 300 minutes of at least moderate physical activity per week
• Unwillingness to either complete the study requirements or to be randomised into control or intervention group.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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140 participants in 2 patient groups

Gestafitos

Experimental group

Description:

This is a longitudinal study developed, which is the continuation of the GESTAtion and FITness (GESTAFIT) Project. The main purpose is to evaluate the influence of a concurrent physical exercise program during pregnancy (developed under the GESTAFIT project) on the body composition, physical fitness, brain structure, and motor, cognitive, and language development of the offspring at four years of age.

Treatment:

Other: Exercise intervention

Other: Control group

Placentraining

Experimental group

Description:

This is a retrospective study which purpose is to analyse the status of placentas of women participating in the GESTAFIT project, in which a concurrent physical exercise programme was developed. This rigorous design will allow us to test our central hypothesis that exercise during pregnancy will produce greater improvements in placental metabolic pathways associated with pregnancy complications, and is associated with better pregnancy and newborn outcomes.

Treatment:

Other: Exercise intervention

Other: Control group