Pregnancy
Conditions
Keywords
Exercise, Motor Activity
Brief summary
Metabolic alterations during pregnancy have been associated with adverse maternal-fetal outcomes, including low birth weight and pregnancy complications. Maternal endothelial dysfunction, oxidative stress, insulin resistance, and placental mitochondrial dysfunction are thought to contribute to fetal metabolic disturbances. Lifestyle changes, such as structured exercise during pregnancy, may modulate maternal and placental factors. This randomized controlled trial will evaluate the effects of a multicomponent exercise program during the second and third trimester on maternal functional capacity, vascular health, anthropometry, metabolic biomarkers, placental function, and newborn health outcomes.
Detailed description
To investigate the effects of a multicomponent supervised exercise program during pregnancy on the maternal-fetal unit.
Interventions
BEHAVIORALIntervention
Exercise
Sponsors
Instituto de Investigación Sanitaria de Navarra (IdiSNA)
NavarraBiomed Biomedical Research Center
Complejo Hospitalario de Navarra
Universidad Pública de Navarra
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
Supervised exercise training: the women will attend at least 2 weekly sessions consisting of aerobic exercise (walking on treadmills), strength training (for upper body, back, abdomen and legs) as well as pelvic floor muscle exercises. Each session is 60 minutes and lead by a exercise physiologist. The women will also go through motivational interviewing sessions throughout the intervention period and are encouraged to do home exercise training in addition to the supervised exercise.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Primigravid women * Gestational age 16-20 weeks * No severe malformations on ultrasound * Regular prenatal care and medical clearance from obstetrician * Being healthy and able to exercise following American College of Obstetricians and Gynecologists (ACOG) guidelines
Exclusion criteria
* Medical or obstetric complication excluding exercise ( ACOG guideline) Major surgery or trauma in past year * Cancer diagnosis * Cervical incompetence * History of ≥2 spontaneous abortions * Multiple pregnancy * Vaginal bleeding, placenta previa, or threatened abortion * COPD, asthma, or chronic bronchitis * Renal, musculoskeletal, cardiovascular, or systemic infections limiting exercise * Polyhydramnios or oligohydramnios * Not availability to attend to the physical exercise program
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiorespiratory fitness (Vo2max) | at the 16th and 34-36th week of gestation | The modified cycle protocol will be performed to estimate maximal oxygen uptake (VO2max), and will be used as measure of cardiorespiratory fitness. |
| Maternal weight gain (kg) | 34-36th week of gestation | Maternal weight gain will be defined as the weight change from baseline measurement to the last measurement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resting heart rate (bpm) | at the 16th and 34-36th week of gestation | 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. |
| Muscle strength (kg) | at the 16th and 34-36th week of gestation | The handgrip strength and leg press test will be used as measure of strength (upper and lower limbs) |
| Whole bone mineral density (g/cm2) | at the 16th to 34-36th week of gestation | Dual-energy X-ray absorptiometry (DXA) body composition measure |
| Fat free mass | at the 16th to 34-36th week of gestation | Dual-energy X-ray absorptiometry (DXA) body composition measure |
| Lean mass/fat mass ratio | at the 16th to 34-36th week of gestation | Dual-energy X-ray absorptiometry (DXA) body composition measure |
| Fat mass (kg) | at the 16th to 34-36th week of gestation | Dual-energy X-ray absorptiometry (DXA) body composition measure |
| Fat mass index (kg/m2) | at the 16th to 34-36th week of gestation | Dual-energy X-ray absorptiometry (DXA) body composition measure |
| Appendicular lean mass index (kg/m2) | at the 16th to 34-36th week of gestation | Dual-energy X-ray absorptiometry (DXA) body composition measure |
| Lean mass index (kg/m2) | at the 16th to 34-36th week of gestation | Dual-energy X-ray absorptiometry (DXA) body composition measure |
| Lean mass (kg) | at the 16th to 34-36th week of gestation | Dual-energy X-ray absorptiometry (DXA) body composition measure |
| Physical activity and sedentary behaviour (in minutes) | at the 16th and 34-36th week of gestation | 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 5-7 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). |
| Pittsburgh Sleep Quality Index | at the 16th and 34-36th week of gestation | 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 5-7 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). |
| Quality of life (EQ-5D-5L) | at the 16th and 34-36th week of gestation | We will use the EQ-5D-5L survey, for assessing health-related quality of life, ranging from 0 (worst imaginable health state) to 100 (best imaginable health state), with higher scores representing better perceived health. |
| Epidemiological Studies-Depression Scale questionnaire | at the 16th and 34-36th week of gestation | 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. The total score ranges from 0 to 60, with higher scores indicating more severe depressive symptoms. |
| Oswestry Disability Index score | at the 16th and 34-36th week of gestation | Low-back pain will be assessed with the Spanish version of the Oswestry Disability Index (ODI) score. The final ODI score ranges from 0 to 100, where 0 represents no disability and 100 represents maximum disability. |
| Physical Activity index | at the 16th and 34-36th week of gestation | Physical Activity will be assessed with the Spanish adaptation and validation of the Pregnancy Physical Activity Questionnaire (PPAQ). The scale ranges from 0 to 400+ MET·h/week, with higher scores indicating greater energy expenditure and physical activity levels. |
| Pain Visual Analogue Scale | at the 16th and 34-36th week of gestation | General or specific pain intensity will also be assessed using the Pain Visual Analogue Scale (VAS), a validated self-reported measure of perceived pain intensity. The VAS consists of a 10-centimeter horizontal line anchored by no pain (0) and worst imaginable pain (10) at each end. Participants will indicate their current pain level by marking a point along the line, with higher scores representing greater pain intensity. |
| Cognitive Function | at the 16th and 34-36th week of gestation | Global cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA), a validated screening tool that evaluates multiple cognitive domains, including executive function, memory, attention, language, and visuospatial abilities. The total score ranges from 0 to 30, with higher scores indicating better cognitive performance. |
| Adherence to the Mediterranean Diet | at the 16th and 34-36th week of gestation | Adherence to the Mediterranean dietary pattern will be assessed using the Mediterranean Diet Adherence Screener (MEDAS), a validated 14-item questionnaire designed to evaluate compliance with key components of the Mediterranean diet. Each item is scored 0 or 1, depending on whether the dietary criterion is met, yielding a total score ranging from 0 to 14, where higher scores indicate greater adherence to the Mediterranean diet. |
| Psychological Distress | at the 16th and 34-36th week of gestation | The Kessler Psychological Distress Scale (K10) will be used to assess nonspecific psychological distress, including symptoms of anxiety and depression, experienced over the past four weeks. The K10 consists of 10 items, each rated on a 5-point Likert scale ranging from 1 (none of the time) to 5 (all of the time), resulting in a total score between 10 and 50. Higher scores indicate greater psychological distress. |
| Erythrocytes | at 34th week of gestation and at delivery | Erythrocyte count (×10⁶ cells/µL), will be measured using an automated Coulter haematology analyser (Brand, City, Country). |
| Lipid profile (in mother and cord blood) | at 34th week of gestation and at delivery | Plasma total, high-density lipoprotein and low-density lipoprotein cholesterol and triglycerides (all in mg/dL) will be assessed using an autoanalyzer. |
| Plasma glucose (in mother and cord blood) | at 34th week of gestation and at delivery | Plasma glucose concentrations will be determined using the glucose oxidase enzymatic colorimetric method. |
| Total plasma antioxidant capacity (in mother and cord blood) | at 34th week of gestation and at delivery | Total plasma antioxidant capacity (in maternal and cord blood) will be measured using a commercial colorimetric assay kit based on spectrophotometry, following the manufacturer's instructions. Results will be expressed in Trolox equivalents (mmol Trolox/L), where higher values indicate greater antioxidant capacity. |
| Antioxidant enzymes activity (in mother and cord blood) | at 34th week of gestation and at delivery | Erythrocyte membrane catalase, glutathione peroxidase, and superoxide dismutase enzyme activities will be measured by spectrophotometry using standard biochemical assays. Results will be expressed in units per milligram of hemoglobin (U/mg Hb), where higher values indicate greater enzymatic antioxidant activity. |
| Glycosylated haemoglobin levels (in mother and cord blood) | at 34th week of gestation and at delivery | Glycosylated haemoglobin (HbA1c) will be determined using the enzymatic colorimetric method. |
| Body length and head circumference | At delivery | Length in centimeters (cm), and head circumference in centimeters (cm). |
| Hospitalization days | At delivery | Hospitalization will be recorded as the number and duration of inpatient stays. |
| Pro- and anti-inflammatory signal (in mother and cord blood) | at 34th week of gestation and at delivery | 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. Other 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. Each outcome will be reported separately, with concentrations expressed in pg/mL or ng/mL, as appropriate for the specific analyte. |
| Birth weight | At delivery | Birth weight will be recorded in grams (g). |
| Delivery complications | At delivery | Mode of delivery (vaginal or caesarean section) and any maternal or neonatal complications occurring during delivery will be obtained from hospital medical records and classified according to the attending obstetrician's report. |
| Apgar score | At delivery | Apgar score will be evaluated at 1 and 5 minutes after delivery by trained obstetric or neonatal staff, following standard clinical procedures. Scores range from 0 to 10, with higher values indicating better neonatal condition. |
| Polypharmacy | At delivery and 6 and 12 months postpartum | Polypharmacy will be defined as the concurrent use of five or more medications. |
| Resting energy expenditure | at the 16th and 34-36th week of gestation | Resting energy expenditure is measured in the fasting and fed state by indirect calorimetry |
| Haematocrit | at 34th week of gestation and at delivery | Haemoglobin concentration (g/dL) will be measured using an automated Coulter haematology analyser (Brand, City, Country). |
| Mean corpuscular volume | at 34th week of gestation and at delivery | Mean corpuscular volume (fL) will be measured using an automated Coulter haematology analyser (Brand, City, Country). |
| Insulin levels (in mother and cord blood) | at 34th week of gestation and at delivery | Plasma insulin levels will be quantified by enzyme-linked immunosorbent assay (ELISA). |
| Cost-effectiveness analyses | At delivery and 6 and 12 months postpartum | Cost-effectiveness analyses will be conducted based on health service utilization and associated costs extracted from the hospital database. Each outcome will be reported separately, with appropriate units (e.g., number of admissions, days hospitalized, number of medications, EQ-5D-5L index score, euros): Count (episodes, days, or medications), EQ-5D-5L index (score), and euros (€). |
| Platelet count and leukocyte | at 34th week of gestation and at delivery | Platelet count (×10³ cells/µL) and leukocyte count (×10³ cells/µL) will be measured using an automated Coulter haematology analyser (Brand, City, Country). |
| Systolic and diastolic blood pressure (mmHg) | at the 16th and 34-36th week of gestation | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Placental mitochondrial leak respiration | At delivery | Mitochondrial oxygen (O₂) flux will be measured in placental tissue using high-resolution respirometry (Oroboros O₂k, Oroboros Instruments, Innsbruck, Austria). Tissue samples will be analyzed in fresh homogenates under controlled substrate-uncoupler-inhibitor titration (SUIT) protocols to evaluate basal, leak, and maximal respiratory states. Oxygen flux will be expressed as picomoles of O₂ consumed per second per milligram of tissue (pmol O₂·s-¹·mg-¹). |
| Changes to maternal, placenta and umbilical cord proteome | At delivery | Changes in proteome will be analyzed using the Olink® proximity extension assay (PEA) technology, following the manufacturer's standardized protocol (Olink Proteomics, Uppsala, Sweden). Protein abundance will be expressed as normalized protein expression (NPX) units, where higher NPX values indicate greater relative protein concentration. |
Countries
Spain
Outcome results
None listed