Effects of Exercise During Gestation on Maternal and Foetal Health

NCT02582567 | Completed

• 1 other identifier: GESTAFIT
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pregnancy

Keywords

Pregnant Women; Quality of Life; Exercise; Sleep; Fetal Research; Diet, Mediterranean; Physical Fitness; Oxidative stress; Inflammation

Outcome Measures

Primary Outcomes (3)

• Insulin sensitivity derived from the homeostatic model assessment for insulin resistance (HOMA-IR)

  Insulin sensitivity will be derived from the homeostatic model assessment for insulin resistance (HOMA-IR), which will be calculated using the formula \[fasting insulin (μIU/mL) x fasting glucose (mg/dL)\]/405.

  34th week of gestation

• Maternal weight gain (kg)

  Maternal weight gain will be defined as the weight change from baseline measurement to the last measurement

  34th week of gestation

• Neonatal insuline-glucose index

  Neonatal insulin sensitivity will be assessed through the ratio glucose/insulin.

  At delivery in cord blood samples

Secondary Outcomes (48)

• Systolic and diastolic blood pressure (mmHg)

  at the 16th and 34th week of gestation

• Resting heart rate (bpm)

  at the 16th and 34th week of gestation

• The Mediterranean Diet Score

  at the 16th and 34th week of gestation

• Cardiorespiratory fitness (Vo2max)

  at the 16th and 34th week of gestation

• Cardiorespiratory fitness (meters in the 6-min walk test)

  at the 16th and 34th week of gestation

Study Arms (2)

Gestafitos

EXPERIMENTAL

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.

Other: Exercise intervention; Other: Control group

Placentraining

EXPERIMENTAL

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.

Other: Exercise intervention; Other: Control group

Interventions

Exercise intervention OTHER

The exercise intervention will be performed in two groups so that each group will have 12-13 participants.The groups will train 3 days/week (60min per session) from the 16th week of gestation until delivery. The exercise intervention group will go through different phases of training: a) Learning phase: which will involve the intervention plan, the goals we want to work, and how we will perform it; b) Movement Learning phase: theoretical and practical sessions with the explanation of movements and ergonomic basic patterns; and c) Physical Fitness Training phase: with training sessions aimed at improving fitness and weight loss, and training sessions focused on a correct pelvic mobilization for the delivery.The intensity will be adapted during the exercise program based on the week of gestation and each pregnant heart rate. The sessions will consist of a mixed work, composed of circuits where both muscular and cardiovascular conditioning will be implemented.

Gestafitos; Placentraining

Control group OTHER

Usual care, not exercise.

Gestafitos; Placentraining

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Granada: lead

Study Sites (1)

Pilar Cabello-Turmo

Granada, Granada, 18071, Spain

Location

Related Publications (5)

• Marin-Jimenez N, Baena-Garcia L, Coll-Risco I, Flor-Alemany M, Castro-Pinero J, Aparicio VA. Influence of a Concurrent Exercise Training Program on Health-Related Quality of Life During Advanced Pregnancy: The GESTAFIT Project. Sports Health. 2024 Jul-Aug;16(4):518-526. doi: 10.1177/19417381231189730. Epub 2023 Jul 31.

  PMID: 37525559 DERIVED

• Aparicio VA, Baena-Garcia L, Flor-Alemany M, Martinez-Gonzalez LJ, Varela-Lopez A, Sanchez C, Quiles JL. Differences in maternal and neonatal cardiometabolic markers and placenta status by foetal sex. The GESTAFIT project. Womens Health (Lond). 2022 Jan-Dec;18:17455057221117976. doi: 10.1177/17455057221117976.

  PMID: 35989614 DERIVED

• Baena-Garcia L, Coll-Risco I, Ocon-Hernandez O, Romero-Gallardo L, Acosta-Manzano P, May L, Aparicio VA. Association of objectively measured physical fitness during pregnancy with maternal and neonatal outcomes. The GESTAFIT Project. PLoS One. 2020 Feb 18;15(2):e0229079. doi: 10.1371/journal.pone.0229079. eCollection 2020.

  PMID: 32069319 DERIVED

• Aparicio VA, Ocon O, Diaz-Castro J, Acosta-Manzano P, Coll-Risco I, Borges-Cosic M, Romero-Gallardo L, Moreno-Fernandez J, Ochoa-Herrera JJ. Influence of a Concurrent Exercise Training Program During Pregnancy on Colostrum and Mature Human Milk Inflammatory Markers: Findings From the GESTAFIT Project. J Hum Lact. 2018 Nov;34(4):789-798. doi: 10.1177/0890334418759261. Epub 2018 Mar 30.

  PMID: 29601268 DERIVED

• Aparicio VA, Ocon O, Padilla-Vinuesa C, Soriano-Maldonado A, Romero-Gallardo L, Borges-Cosic M, Coll-Risco I, Ruiz-Cabello P, Acosta-Manzano P, Estevez-Lopez F, Alvarez-Gallardo IC, Delgado-Fernandez M, Ruiz JR, Van Poppel MN, Ochoa-Herrera JJ. Effects of supervised aerobic and strength training in overweight and grade I obese pregnant women on maternal and foetal health markers: the GESTAFIT randomized controlled trial. BMC Pregnancy Childbirth. 2016 Sep 29;16(1):290. doi: 10.1186/s12884-016-1081-y.

  PMID: 27680325 DERIVED

MeSH Terms

Conditions

Motor Activity; Inflammation

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: October 6, 2015
• First Posted: October 21, 2015
• Study Start: October 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2018
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

ES (1)