Benefits of Exercise for the Maternal-Fetal Unit During Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Cardiorespiratory fitness (Vo2max)
研究概览
简要总结
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.
详细描述
To investigate the effects of a multicomponent supervised exercise program during pregnancy on the maternal-fetal unit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Cardiorespiratory fitness (Vo2max)
时间窗: 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)
时间窗: 34-36th week of gestation
Maternal weight gain will be defined as the weight change from baseline measurement to the last measurement
次要结局
- Systolic and diastolic blood pressure (mmHg)(at the 16th and 34-36th week of gestation)
- Resting heart rate (bpm)(at the 16th and 34-36th week of gestation)
- Muscle strength (kg)(at the 16th and 34-36th week of gestation)
- Whole bone mineral density (g/cm2)(at the 16th to 34-36th week of gestation)
- Fat free mass(at the 16th to 34-36th week of gestation)
- Lean mass/fat mass ratio(at the 16th to 34-36th week of gestation)
- Fat mass (kg)(at the 16th to 34-36th week of gestation)
- Fat mass index (kg/m2)(at the 16th to 34-36th week of gestation)
- Appendicular lean mass index (kg/m2)(at the 16th to 34-36th week of gestation)
- Lean mass index (kg/m2)(at the 16th to 34-36th week of gestation)
- Lean mass (kg)(at the 16th to 34-36th week of gestation)
- Physical activity and sedentary behaviour (in minutes)(at the 16th and 34-36th week of gestation)
- Pittsburgh Sleep Quality Index(at the 16th and 34-36th week of gestation)
- Quality of life (EQ-5D-5L)(at the 16th and 34-36th week of gestation)
- Epidemiological Studies-Depression Scale questionnaire(at the 16th and 34-36th week of gestation)
- Oswestry Disability Index score(at the 16th and 34-36th week of gestation)
- Physical Activity index(at the 16th and 34-36th week of gestation)
- Pain Visual Analogue Scale(at the 16th and 34-36th week of gestation)
- Cognitive Function(at the 16th and 34-36th week of gestation)
- Adherence to the Mediterranean Diet(at the 16th and 34-36th week of gestation)
- Psychological Distress(at the 16th and 34-36th week of gestation)
- Erythrocytes(at 34th week of gestation and at delivery)
- Lipid profile (in mother and cord blood)(at 34th week of gestation and at delivery)
- Plasma glucose (in mother and cord blood)(at 34th week of gestation and at delivery)
- Total plasma antioxidant capacity (in mother and cord blood)(at 34th week of gestation and at delivery)
- Antioxidant enzymes activity (in mother and cord blood)(at 34th week of gestation and at delivery)
- Apgar score(At delivery)
- Pro- and anti-inflammatory signal (in mother and cord blood)(at 34th week of gestation and at delivery)
- Birth weight(At delivery)
- Delivery complications(At delivery)
- Polypharmacy(At delivery and 6 and 12 months postpartum)
- Resting energy expenditure(at the 16th and 34-36th week of gestation)
- Haematocrit(at 34th week of gestation and at delivery)
- Platelet count and leukocyte(at 34th week of gestation and at delivery)
- Mean corpuscular volume(at 34th week of gestation and at delivery)
- Insulin levels (in mother and cord blood)(at 34th week of gestation and at delivery)
- Glycosylated haemoglobin levels (in mother and cord blood)(at 34th week of gestation and at delivery)
- Body length and head circumference(At delivery)
- Hospitalization days(At delivery)
- Cost-effectiveness analyses(At delivery and 6 and 12 months postpartum)
研究者
Robinson Ramírez-Vélez
Principal Investigator
Universidad Pública de Navarra