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AzTrials

PregnancyGESTAFITNCT02582567

Effects of Exercise During Gestation on Maternal and Foetal Health

A study testing Exercise intervention in people with Pregnancy, run by Universidad de Granada at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 25 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
Pregnancy
What is being tested?
Exercise intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
1 siteSpain
Study dates
Oct 2015to Jul 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 14Show fewer
  • 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 locations and contacts

1 site in 1 country.

Spain1 site
  • Pilar Cabello-Turmo

    Granada, Granada, 18071

Other trials in Spain

About this study

Official title: Effects of Supervised Exercise During Gestation on Maternal and Foetal Health Markers. The GESTAFIT Project

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
Being tested
Exercise intervention, Control group
Keywords
Pregnant Women, Quality of Life, Exercise, Sleep, Fetal Research, Diet, Mediterranean, Physical Fitness, Oxidative stress, Inflammation
Medical subject headings
Motor Activity, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise interventionOther

    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.

  • Control groupOther

    Usual care, not exercise.

Study groups in NCT02582567
Study groupRoleWhat they receive
GestafitosExperimentalThis 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.
Receives: Other: Exercise intervention; Other: Control group
PlacentrainingExperimentalThis 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.
Receives: Other: Exercise intervention; Other: Control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 34th week of gestation

  2. Maternal weight gain (kg)

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

    Measured: 34th week of gestation

  3. Neonatal insuline-glucose index

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

    Measured: At delivery in cord blood samples

Secondary outcomes (48)
  1. Systolic and diastolic blood pressure (mmHg)

    Systolic and diastolic blood pressure (mmHg) will be measured after 5 minutes of rest, on 2 separate occasions (with 2 minutes between trials), with the person seated (Omron Health Care Europe B.V. Hoolddorp). The lowest value of the two trials will be selected for the analysis.

    Measured: at the 16th and 34th week of gestation

  2. Resting heart rate (bpm)

    Resting heart rate (bpm), will be measured after 5 minutes of rest, on 2 separate occasions (with 2 minutes between trials), with the person seated (Omron Health Care Europe B.V. Hoolddorp). The lowest value of the two trials will be selected for the analysis.

    Measured: at the 16th and 34th week of gestation

  3. The Mediterranean Diet Score

    The Mediterranean Diet Score in a version adapted to the specific needs during pregnancy for Fe, Ca and folic acid will be used to assess the adherence to the traditional Mediterranean dietary pattern.

    Measured: at the 16th and 34th week of gestation

  4. Cardiorespiratory fitness (Vo2max)

    The modified Bruce protocol will be performed to estimate maximal oxygen uptake (VO2max), and will be used as measure of cardiorespiratory fitness.

    Measured: at the 16th and 34th week of gestation

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

    We perform the 6-minute walk test, which measures the maximum distance (in meters) each participant can walk in 6 minutes along a 45.7 m rectangular course.

    Measured: at the 16th and 34th week of gestation

  6. Muscle strength (kg)

    The handgrip strength test will be used as measure of strength

    Measured: at the 16th and 34th week of gestation

  7. Flexibility (cm)

    The back-scratch test will be used as measure of flexibility

    Measured: at the 16th and 34th week of gestation

  8. Physical activity and sedentary behaviour (in minutes)

    Accelerometry will be used to objectively assess physical activity and sedentary time. Women will be asked to wear a tri-axial accelerometer (ActiSleep+, Pensacola, Florida, United States) for 9 consecutive days, starting the same day they receive the monitor (e.g. participants who receive the accelerometer on Monday, will carry the device until Tuesday of the next week). Participants will be instructed to wear the accelerometer during the whole day (24 hours) on their wrist attached by an elastic belt. Time (in minutes) engaged in light, moderate, and moderate-vigorous intensity PA and sedentary time will be calculated. This accelerometer has been previously used in pregnancy with similar methodology as described in the present protocol.

    Measured: at the 16th, 24th and 34th week of gestation

  9. Sleep behaviours (through accelerometry)

    Behaviours related to sleep, such as sleep onset, sleep latency, total sleep time, number and duration of awakenings and sleep efficiency will be objectively calculated by using a triaxial accelerometer (ActiSleep+, Pensacola, Florida, United States). The data analysis of such ActiSleep accelerometry data will be carried out through its specific software (Actilife).

    Measured: at the 16th, 24th and 34th week of gestation

  10. Pittsburgh Sleep Quality Index

    It will be used to assess sleep quality and disturbances over a l-month time interval.

    Measured: at the 16th, 24th and 34th week of gestation

  11. Insomnia Symptoms Questionnaire

    The presence of symptoms of insomnia will be measured with the Insomnia Symptoms Questionnaire, validated in pregnant women.

    Measured: at the 16th, 24th and 34th week of gestation

  12. Quality of life (Short-Form Health Survey 36)

    We will use the Short-Form Health Survey 36, for assessing health-related quality of life.

    Measured: at the 16th and 34th week of gestation

  13. Epidemiological Studies-Depression Scale questionnaire

    The pregnant antenatal depression levels will be assessed by the Center for Epidemiological Studies-Depression Scale questionnaire, which is validated and widely employed in pregnancy.

    Measured: at the 16th and 34th week of gestation

  14. State Trait Anxiety Index.

    Anxiety levels will be assessed with the State Trait Anxiety Index.

    Measured: at the 16th and 34th week of gestation

  15. The Detention of Restless Legs Syndrome questionnaire

    The "Restless Legs Syndrome" largely determines the quality of life for many pregnant and is related to their levels of depression and sleep quality. The Spanish version of the Detention of Restless Legs Syndrome questionnaire will be employed to assess the presence and severity of this syndrome .

    Measured: at the 16th and 34th week of gestation

  16. Oswestry Disability Index score

    Low-back pain will be assessed with the Spanish version of the Oswestry Disability Index score

    Measured: at the 16th and 34th week of gestation

  17. Pain Visual Analogue Scale

    Low-back pain intensity will be also assessed with the Pain Visual Analogue Scale

    Measured: at the 16th and 34th week of gestation

  18. 6-item Female Sexual Function Index

    The 6-item Female Sexual Function Index will be used to assess sex function. This instrument is composed of six questions: desire, arousal, lubrication, orgasm, satisfaction and pain. Each question can be scored from 0 to 5 and then summed up to provide a total score.

    Measured: at the 16th and 34th week of gestation

  19. Positive health

    "Positive health" will be evaluated through the following questionnaires:

    1. The Trait Meta-Mood Scale
    2. The Positive and Negative Affect Schedule
    3. The Satisfaction with Life Scale
    4. The 10-item Connor-Davidson Resilience Scale

    Measured: at the 16th and 34th week of gestation

  20. Haematology

    Erythrocyte count, haematocrit, haemoglobin, platelets, leukocytes and erythrocyte mean corpuscular volume will be quantified by Coulter (Brand).

    Measured: at 34th week of gestation and at delivery

  21. Lipid profile (in mother and cord blood)

    Plasma total, high-density lipoprotein and low-density lipoprotein cholesterol and triglycerides (all in mg/dL) will be assessed using an autoanalyzer (Hitachi-Roche p800, F. Hoffmann-La Roche Ltd. Switzerland)

    Measured: at 34th week of gestation and at delivery

  22. Glycaemic profile (in mother and cord blood)

    Plasma glucose, insulin and glycosylated haemoglobinwill be assessed using an autoanalyzer (Hitachi-Roche p800, F. Hoffmann-La Roche Ltd. Switzerland)

    Measured: at 34th week of gestation and at delivery

  23. Total plasma antioxidant capacity (in mother and cord blood)

    It will be measured by using commercial kit (spectrophotometry).

    Measured: at 34th week of gestation and at delivery

  24. Plasma liposoluble antioxidants (in mother and cord blood)

    Plasma vitamin E, retinol, carotene, coenzyme Q10 and coenzyme Q9 will be measured through mass spectrometry

    Measured: at 34th week of gestation and at delivery

  25. Antioxidant enzymes activity (in mother and cord blood)

    Eritrocite membrane catalase, glutathione peroxidase and superoxide dismutase enzymes will be by measured by spectrophotometry.

    Measured: at 34th week of gestation and at delivery

  26. Carbonyl proteins (in mother and cord blood)

    Measurement of carbonyl proteins will be done by using commercial kit (spectrophotometry).

    Measured: at 34th week of gestation and at delivery

  27. Oxidative damage to lipids (in mother and cord blood)

    Measurement of 4-hydroxynonenal and isoprostanes in urine and plasma and hydroperoxides in plasma and erythrocyte membrane by using commercial kits (spectrophotometry and ELISA)

    Measured: at 34th week of gestation and at delivery

  28. Oxidative damage to DNA (in mother and cord blood)

    measurement of 8-hydroxyguanosine in urine and plasma by commercial kits (ELISA).

    Measured: at 34th week of gestation and at delivery

  29. Pro- and anti-inflammatory signal (in mother and cord blood)

    Some maternal and umbilical cord plasma pro-inflammatory and anti-inflammatory cytokines (IL-1β, IL-2, IL-6, IL-8, IL-10, IFN-γ and TNF-α, IL-1ra and TNF Srii α), some adipokines (adiponectin, adipsin, resistin, PAI-active, insulin and leptin) and myokines (irisin) will be measured by the employment of Luminex xMAP technology.

    Measured: at 34th week of gestation and at delivery

  30. Bone biomarkers (in mother and cord blood)

    Various relevant biomarkers related to bone metabolism (ACTH, DKK-1, FGF-23, Osteocalcin, OPN-Osteopontin, Osteoprotegerin, PTH and SOST) will be measured with Luminex xMAP technology.

    Measured: at 34th week of gestation and at delivery

  31. Adiposity-related proteins expression (in mother and cord blood)

    Glucocorticoid receptor; peroxisome proliferation activated receptor (PPAR); the beta-11 hydroxysteroid dehydrogenase type I (11βHSD1), and beta-11 hydroxysteroid dehydrogenase type II (11βHSD2) will be assessed in maternal and umbilical cord blood and in oral mucosa from the mother and newborn.

    Moreover, 4 genes highly involved in foetal and postnatal development of adipose tissue have been selected; two are receptors: the Glucocorticoid receptor and the PPAR-γ, and two are metabolic enzymes: beta-11 hydroxysteroid dehydrogenase type I or 11βHSD1, and 11 beta-hydroxysteroid dehydrogenase type II or 11βHSD2. Of great importance are PPAR-γ1 and PPAR-γ2, which are generated from the same gene by alternative promoter usage and mRNA. We will measure such proteins as well as paraoxonase/arylesterase 1 (PON1) concentrations in maternal and umbilical cord plasma by Polymerase Chain Reaction and Western Blot techniques.

    Measured: At delivery

  32. Anthropometry and Body Composition of the Mother and Child (Gestafitos)

    The height of the mother and child will be recorded using a scale (Seca 22, Hamburg). A comprehensive analysis of body composition will be carried out for both the mother and child (DXA, Hologic Discovery QDR, Nasdaq). We will also record weight (Inbody R20, Biospace, Korea) as well as waist and neck circumference in both the mother and child.

    Measured: 4 ± 1 years after birth

  33. Blood Pressure and Resting Heart Rate of the Mother and Child (Gestafitos)

    Systolic and diastolic blood pressure, along with heart rate, will be measured three times after 5 minutes of rest (Omron Hoolddorp) in both mother and child.

    Measured: 4 ± 1 years after birth

  34. Nutritional Status of the Mother and Child (Gestafitos)

    A food frequency questionnaire and a Mediterranean Diet Adherence questionnaire will be administered. The use of nutritional supplements will also be recorded.

    Measured: 4 ± 1 years after birth

  35. Physical Activity, Sedentary Behavior, and Sleep Quality of the Mother and Child

    We will assess physical activity, sedentary behavior, and sleep-related behaviors (latency, efficiency, etc.) using accelerometers (ActigraphGT3X+, Pensacola, Florida, USA) worn on the wrist for nine consecutive days. Acceleration changes will be recorded in 5-second epochs for children and 60-second epochs for mothers. Data will be collected on total volume and intensity of activity (mean physical activity intensity), energy expenditure, and the number of minutes per day spent at various intensities: low (sedentary), light, moderate, vigorous, and moderate-to-vigorous. Sleep quality will also be recorded using the specific Actisleep software.

    Measured: 4 ± 1 years after birth

  36. Health-Related Physical Fitness of the Child: PREFIT Battery

    Muscular strength, cardiorespiratory fitness, balance, speed, and motor coordination-agility will be assessed using the following PREFIT battery tests: 20m shuttle run test, handgrip dynamometry, standing long jump test, one-leg balance test, and 4x10m shuttle run test, respectively. The PREFIT battery is a feasible, reliable, maximal, and valid tool to assess physical fitness in preschool-aged children.

    Measured: 4 ± 1 years after birth

  37. Brain Structure, Cerebral Blood Flow, and Brain Function via Structural and Functional Magnetic Resonance Imaging (Gestafitos)

    MRI will be conducted at the Brain, Mind and Behavior Research Center (CIMCYC) at the University of Granada. Dr. Irene Esteban-Cornejo, a team member, has coordinated the neuroimaging area of previously funded studies (e.g., the ACTIVEBRAINS project, a randomized controlled trial assessing the effect of exercise on the brain in children). She has completed two research stays at the Monash Institute of Cognitive and Clinical Neurosciences in Australia, holds a Master's degree in advanced MRI analysis, and is the first author of the first two brain articles from the ACTIVEBRAINS project, both published in the prestigious journal Neuroimage. Dr. Esteban-Cornejo has also worked with leading experts in exercise and brain health (Erickson KI, Kramer AF, and Hillman CH) at Northeastern University and the University of Pittsburgh. Dr. Erickson and neuroscientist Marina López-Solà are also part of the current project team.

    Measured: 4 ± 1 years after birth

  38. Cognition (Gestafitos)

    Three key aspects of executive function will be assessed:

    1. Cognitive Inhibition: Assessed via the Stroop test, which involves three conditions evaluating interference when identifying the ink color of words that do not match their meaning.
    2. Cognitive Flexibility: Assessed with two independent tests: Design Fluency Test: Consists of three progressive conditions where participants create unique designs under different rules in 60 seconds, assessing flexibility, creativity, and visual pattern generation. Trail Making Test: Five conditions assessing visual search speed, attention, mental flexibility, working memory, and motor function.
    3. Working Memory: Assessed with a computerized n-back task (see MRI section), which evaluates the ability to simultaneously store and process information.
    4. Intelligence: Assessed with the Kaufman Brief Intelligence Test (KBIT), which includes subtests for verbal and non-verbal intelligence.

    Measured: 4 ± 1 years after birth

  39. Academic Performance (Gestafitos)

    1. Woodcock-Muñoz III Battery: Spanish adaptation of the Woodcock-Johnson III (WJ III), composed of 22 subtests that assess language, mathematics, and science. Selected subtests will be used to assess math fluency, calculation, comprehension, and writing.
    2. School Grades: Parents will also be asked to provide the child's school grades from the academic year(s) during which the assessments take place.

    Other Motor, Cognitive, and Language Development Scales:

    1. Bayley Scales of Infant Development, Third Edition (BSID-III)
    2. Wechsler Intelligence Scale for Children
    3. BENCI Battery (Computerized Neuropsychological Assessment Battery for Children)

    Measured: 4 ± 1 years after birth

  40. Genetic and Epigenetic Analyses (Gestafitos)

    Buccal mucosa samples will be collected from children to analyze the expression of the FTO gene polymorphism rs9939609 and MC4R gene polymorphism rs17782313. DNA will be extracted from saliva using Whatmann® paper supports and organic extraction methods optimized for quality and quantity. Samples will be quantified using a NanoDrop 2000 spectrophotometer (ThermoScientific) and normalized to ~5 ng/µL before being genotyped with TaqMan probes (Applied Biosystems) on a RealTime ABI PRISM® 7900 HT. Unsuccessful samples will be amplified and sequenced using specific primers and analyzed with the 3130 HID Genetic Analyzer (Applied Biosystem). DNA and RNA will be extracted using the QIAamp DNA Mini Kit and DNeasy Blood \& Tissue Kit (Qiagen), and processed with the Qiacube robot.

    Measured: 4 ± 1 years after birth

  41. Oxidative stress and antioxidant defence (Placentraining)

    The content in placenta of fat-soluble antioxidants (tocopherol, coenzyme Q10 and Q9 and retinol) will be analysed by HPLC, and nitric oxide and the total antioxidant capacity by the ABTS method.

    • Oxidative damage to proteins: carbonyl proteins using commercial kits (spectrophotometry).
    • Oxidative damage to lipids: 4-hydroxynonenal and isoprostanes using commercial kits (spectrophotometry and ELISA). Oxidative damage to DNA: 8-hydroxyguanosine by commercial kits (ELISA).

    Measured: after placental expulsion following birth

  42. Expression of markers of biogenesis, autophagy, mitochondrial fusion-fission processes (Placentraining)

    Changes inmitochondrial dynamics and their quality control are a key aspect to explain the observed findings.

    Therefore, using Western-blotting or RT-PCR, the mitochondrial processes of fission (Drp1, Fis1 and OPA1), fusion (Mfn1 and Mfn2), biogenesis (PGC1alpha, Tfam, Sirt1, Nrf1, Nrf2) and autophagy (PARKIN2, PINK1, Beclin-1, ATG8, ATG5, ATG12, VDAC1).

    Measured: after placental expulsion following birth

  43. Trace and ultra-trace minerals (Placentraining)

    The determination of total content of these essential (Ca, Mg, Mn, Fe, Cu, Zn, Se) or toxic elements (Hg, V, Cr, As, Cd, Pb, Ni) in placenta samples will be performed by an ICP-MS instrument (Agilent 7500, Agilent Technologies, Tokyo, Japan) fitted with a Meinhard type nebulizer (Glass Expansion, Romainmotier) and equipped with a He collision cell.

    Measured: after placental expulsion following birth

  44. Genomic and methylation (Placentraining)

    Samples will be processed as it is previously described in the "Genetic analyses section". Genomic and Methylation will be developed by pyrosequencing method. This will be developed for detection of FTO and MC4R genes. Genomic DNA from placentas will be isolated using DNeasy Blood\&Tissue Kit following the recommended protocol (Qiagen N.V, Hi.GE). After checking the quality and quantity of the DNA, the promoters of the FTO and MC4R genes will be amplified by means of predesigned PyroMark CpG Assays. Region amplification using these primers will allow us to directly quantify the methylation status of the CGs within the region. First, we will amplify FTO and MC4R regions of interest by PCR using the PyroMark PCR Kit (QIAGEN N.V, Hi.GE), which enables labelling CG nucleotides susceptible of being methylated. Reaction products (one per sample and gene) will be purified and used for the sequencing reaction.

    Measured: after placental expulsion following birth

  45. Candidate gene expression and Small RNA analysis (Placentraining)

    For a better understanding of the metabolic pathways involved, we will carry out the study of candidate genes, as well as the determination of miRNAs that will allow us to establish a genotype-expression-environment relationship (with Small RNA Sequencing analysis).

    For mRNA and miRNA analysis, placental RNA will be obtained through the kit "RNeasy Mini" (Qiagen) following the manufacturer instructions. RNA integrity will be analyzed by a "RNA 6000 Nano chip" (Agilent) using a Bionalalyzer 2100 (Agilent) and the concentration will be calculated by NanoDrop 2000 (ThermoFisher Scientific).

    Predesigned TaqMan Gene Expression assays (ThermoFisher Scientific) will be used to study the expression of candidate genes: IL6, CXCL8, TNF-alpha, CSF3, BDNF; FTO, MC4R and KL klotho (KL).

    Measured: after placental expulsion following birth

  46. Targeted and untargeted metabolomics and lipidomics analyses

    Targeted metabolomics analyses will be performed using liquid chromatography coupled to mass spectrometry. Lipid species extraction will be extracted from plasma samples with MTBE. Ten μL of the extracted sample will be applied onto UPLC 1290 (Agilent Technologies, Barcelona, Spain) equipped with a reversed-phase column coupled to QTOF mass spectrometer model 6545 (Agilent Technologies, Barcelona, Spain). Data will be collected in positive and negative electrospray modes. MassHunter (Agilent Technologies, Barcelona, Spain) and R software will be used to collect, extract, align, filter and normalize the data using quality controls. Untargeted metabolomics analyses will be performed using liquid chromatography coupled to mass spectrometry. Metabolite extraction will be extracted from plasma samples with methanol.

    Measured: after placental expulsion following birth

  47. Toxics (Placentraining)

    Concentrations of free bioactive phenols will be determined by multiclass ultra-high-performance liquid chromatography-tandem mass spectrometry (UHPLC-MS/MS). The following phenols will be assessed:

    bisphenol A; parabens: methylparaben, ethylparaben, propylparaben, butylparaben; benzofenonas (BzP): BzP-1, BzP-2, BzP-3, BzP-6, BzP-8, 4-hydroxy-BzP. Concentrations of perfluoroalkyl substances in placenta will be assessed by coupling salt assisted liquid-liquid extraction with dispersive liquid-liquid microextraction and UHPLC-MS/MS. The following perfluoroalkyl substances will be measured: PFHxA, PFHpA, PFOA, PFNA, PFDA, PFUnA, PFDoA, PFTrA, PFHxS and PFOS.

    Measured: after placental expulsion following birth

  48. Inflammatory, anti-inflammatory, vasculogenesis and angiogenesis markers (Placentraining)

    We will use Luminex xMAP technology (Millipore, Darmstadt, Germany) kits to assess placenta Fractalkine, IL-1α, IL1β, IL-RA, IL-2, IL-6, IL-8, IL-10, IFN-γ, TNF-α, TNF-β, Brain-derived neurotrophic factor, Epidermal growth factor, Fibroblast growth factor 2, Granulocyte-colony stimulating factor, Granulocyte-macrophage colony-stimulating factor, Platelet-derived growth factor-AA, Monocyte chemoattractant protein-1, Vascular endothelial growth factor. For these determination we will use Human Sepsis Magnetic Bead Panel 3 Multiplex Assay (cat. No. HTH17MAG-14K).

    Measured: after placental expulsion following birth

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2015 (estimated)
  2. Study startOct 2015
  3. Primary completionJul 2017
  4. Study completionJul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Single group
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02582567
Sponsor's protocol ID
GESTAFIT
Acronym
GESTAFIT
Status last verified
Nov 2025
First submitted
6 Oct 2015
Last updated
17 Nov 2025
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 37525559
  • 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.

    PubMed 35989614
  • 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.

    PubMed 32069319
  • 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.

    PubMed 29601268
  • 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.

    PubMed 27680325

Questions about this trial

What is this clinical trial studying?

A study testing Exercise intervention in people with Pregnancy, run by Universidad de Granada at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Insulin sensitivity derived from the homeostatic model assessment for insulin resistance (HOMA-IR) (time frame: 34th week of gestation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02582567, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.

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