Exercise During Pregnancy: Effects on the Maternal-Fetal Unit

NCT07264231 | Enrolling By Invitation DMC

• 1 other identifier: PI_2024/148
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy

Keywords

Exercise; Motor Activity

Outcome Measures

Primary Outcomes (2)

• Cardiorespiratory fitness (Vo2max)

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

  at the 16th and 34-36th week of gestation

• Maternal weight gain (kg)

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

  34-36th week of gestation

Secondary Outcomes (40)

• 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

Other Outcomes (2)

• Placental mitochondrial leak respiration

  At delivery

• Changes to maternal, placenta and umbilical cord proteome

  At delivery

Study Arms (2)

Exercise training

EXPERIMENTAL

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.

Behavioral: Intervention

Control

NO INTERVENTION

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

Interventions

Intervention BEHAVIORAL

Exercise

Exercise training

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Pública de Navarra: lead
• Fundación Instituto de Investigación Sanitaria de Navarra: collaborator
• NavarraBiomed Biomedical Research Center: collaborator
• Complejo Hospitalario de Navarra: collaborator

Study Sites (1)

Navarrabiomed, Hospital Universitario de Navarra (HUN) and Universidad Pública de Navarra (UPNA)

Pamplona, Navarre, 31010, Spain

Location

Related Publications (3)

• Ramirez-Velez R, Aguilar de Plata AC, Escudero MM, Echeverry I, Ortega JG, Salazar B, Rey JJ, Hormiga C, Lopez-Jaramillo P. Influence of regular aerobic exercise on endothelium-dependent vasodilation and cardiorespiratory fitness in pregnant women. J Obstet Gynaecol Res. 2011 Nov;37(11):1601-8. doi: 10.1111/j.1447-0756.2011.01582.x. Epub 2011 Jul 6.

  PMID: 21733037 RESULT

• Ramirez-Velez R, Lobelo F, Aguilar-de Plata AC, Izquierdo M, Garcia-Hermoso A. Exercise during pregnancy on maternal lipids: a secondary analysis of randomized controlled trial. BMC Pregnancy Childbirth. 2017 Nov 28;17(1):396. doi: 10.1186/s12884-017-1571-6.

  PMID: 29179683 RESULT

• Pinzon DC, Zamora K, Martinez JH, Florez-Lopez ME, de Plata AC, Mosquera M, Ramirez-Velez R. Type of delivery and gestational age is not affected by pregnant Latin-American women engaging in vigorous exercise: a secondary analysis of data from a controlled randomized trial. Rev Salud Publica (Bogota). 2012 Oct;14(5):731-43.

  PMID: 24652353 RESULT

MeSH Terms

Conditions

Motor Activity

Interventions

Methods

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: December 4, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 15, 2027
• Study Completion (Estimated): December 20, 2027
• Last Updated: December 4, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)