Clinical trial NCT02582567: Effects of Exercise During Gestation on Maternal and Foetal Health
Official title: Effects of Supervised Exercise During Gestation on Maternal and Foetal Health Markers. The GESTAFIT Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Keywords: Pregnant Women
Quality of Life
Exercise
Sleep
Fetal Research
Diet, Mediterranean
Physical Fitness
Oxidative stress
Inflammation
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2015-10-21
Enrollment: 140
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Insulin sensitivity derived from the homeostatic model assessment for insulin resistance (HOMA-IR)
timeFrame: 34th week of gestation
measure: Maternal weight gain (kg)
timeFrame: 34th week of gestation
measure: Neonatal insuline-glucose index
timeFrame: At delivery in cord blood samples
Secondary outcomes:
measure: Systolic and diastolic blood pressure (mmHg)
timeFrame: at the 16th and 34th week of gestation
measure: Resting heart rate (bpm)
timeFrame: at the 16th and 34th week of gestation
measure: The Mediterranean Diet Score
timeFrame: at the 16th and 34th week of gestation
measure: Cardiorespiratory fitness (Vo2max)
timeFrame: at the 16th and 34th week of gestation
measure: Cardiorespiratory fitness (meters in the 6-min walk test)
timeFrame: at the 16th and 34th week of gestation
measure: Muscle strength (kg)
timeFrame: at the 16th and 34th week of gestation
measure: Flexibility (cm)
timeFrame: at the 16th and 34th week of gestation
measure: Physical activity and sedentary behaviour (in minutes)
timeFrame: at the 16th, 24th and 34th week of gestation
measure: Sleep behaviours (through accelerometry)
timeFrame: at the 16th, 24th and 34th week of gestation
measure: Pittsburgh Sleep Quality Index
timeFrame: at the 16th, 24th and 34th week of gestation
measure: Insomnia Symptoms Questionnaire
timeFrame: at the 16th, 24th and 34th week of gestation
measure: Quality of life (Short-Form Health Survey 36)
timeFrame: at the 16th and 34th week of gestation
measure: Epidemiological Studies-Depression Scale questionnaire
timeFrame: at the 16th and 34th week of gestation
measure: State Trait Anxiety Index.
timeFrame: at the 16th and 34th week of gestation
measure: The Detention of Restless Legs Syndrome questionnaire
timeFrame: at the 16th and 34th week of gestation
measure: Oswestry Disability Index score
timeFrame: at the 16th and 34th week of gestation
measure: Pain Visual Analogue Scale
timeFrame: at the 16th and 34th week of gestation
measure: 6-item Female Sexual Function Index
timeFrame: at the 16th and 34th week of gestation
measure: Positive health
timeFrame: at the 16th and 34th week of gestation
measure: Haematology
timeFrame: at 34th week of gestation and at delivery
measure: Lipid profile (in mother and cord blood)
timeFrame: at 34th week of gestation and at delivery
measure: Glycaemic profile (in mother and cord blood)
timeFrame: at 34th week of gestation and at delivery
measure: Total plasma antioxidant capacity (in mother and cord blood)
timeFrame: at 34th week of gestation and at delivery
measure: Plasma liposoluble antioxidants (in mother and cord blood)
timeFrame: at 34th week of gestation and at delivery
measure: Antioxidant enzymes activity (in mother and cord blood)
timeFrame: at 34th week of gestation and at delivery
measure: Carbonyl proteins (in mother and cord blood)
timeFrame: at 34th week of gestation and at delivery
measure: Oxidative damage to lipids (in mother and cord blood)
timeFrame: at 34th week of gestation and at delivery
measure: Oxidative damage to DNA (in mother and cord blood)
timeFrame: at 34th week of gestation and at delivery
measure: Pro- and anti-inflammatory signal (in mother and cord blood)
timeFrame: at 34th week of gestation and at delivery
measure: Bone biomarkers (in mother and cord blood)
timeFrame: at 34th week of gestation and at delivery
measure: Adiposity-related proteins expression (in mother and cord blood)
timeFrame: At delivery
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Pilar Cabello-Turmo
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.