Exercise During Pregnancy: Effects on the Maternal-Fetal Unit

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2027-12-20

Brief Summary

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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.

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Detailed Description

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

Conditions

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Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Exercise training

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.

Group Type EXPERIMENTAL

Intervention

Intervention Type BEHAVIORAL

Exercise

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Intervention

Exercise

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes