Exercise During Pregnancy: Effects on the Maternal-Fetal Unit (PREGFIT)

Universidad Pública de Navarra

Status: Invitation-only

Conditions: Pregnancy

Treatments: Behavioral: Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT07264231

PI_2024/148

Details and patient eligibility

About

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.

Full description

To investigate the effects of a multicomponent supervised exercise program during pregnancy on the maternal-fetal unit.

Enrollment: 64 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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64 participants in 2 patient groups

Exercise training

Experimental group

Description:

Participants will perform a supervised aerobic exercise program at 70% of maximum heart rate (HRmax), for 45 minutes per session, 3 times per week, during 12 weeks. Each session will follow a standardized protocol: 10 minutes of warm-up, 30 minutes of aerobic exercise, 5 minutes of cool-down and stretching. In addition, strength training sessions will be included 1-2 times per week. All exercise sessions will be delivered by qualified professionals, including exercise specialists, nutritionists, and physiotherapists with \>3 years of experience and a master's-level education in the field. The intervention will be conducted at the Exercise Physiology Unit (E-FIT Group Laboratory), Navarrabiomed Research Center, Pamplona, Spain.

Treatment:

Behavioral: Intervention

Control

No Intervention group

Description:

Usual care as provided by the health services in Spain. The investigators will not advice the women to be inactive.