Effects of Exercise During Gestation on Maternal and Foetal Health

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

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2018-07-31

Brief Summary

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The main objective of this project is to assess the effects of a novel and supervised exercise intervention in overweight pregnant and their newborn.

Methods/Design: The present study is a Randomized Controlled Trial. Sixty overweight pregnant interested in participate in the intervention program will be randomly assigned to either exercise (3 sessions/week), or to usual care (control) group (30 pregnant per group). The primary outcome measures are maternal weight gain, and maternal and neonatal glycaemic profile. Secondary outcomes measure are: i) body composition; ii) dietary patterns; iii) physical fitness; iv) objectively measured physical activity and sedentary behaviour; v) sleep quality; vi) mental health, quality of life and positive health; vii) haematology and biochemical analysis; viii) oxidative stress; ix) pro- and anti-inflammatory markers; x) bone health biomarkers; xi) adiposity-related proteins expression. The data will be analysed on an intention-to-treat basis and per protocol.

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Detailed Description

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Conditions

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Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Gestafitos

This is a longitudinal study developed, which is the continuation of the GESTAtion and FITness (GESTAFIT) Project. The main purpose is to evaluate the influence of a concurrent physical exercise program during pregnancy (developed under the GESTAFIT project) on the body composition, physical fitness, brain structure, and motor, cognitive, and language development of the offspring at four years of age.

Group Type EXPERIMENTAL

Exercise intervention

Intervention Type OTHER

The exercise intervention will be performed in two groups so that each group will have 12-13 participants.The groups will train 3 days/week (60min per session) from the 16th week of gestation until delivery. The exercise intervention group will go through different phases of training: a) Learning phase: which will involve the intervention plan, the goals we want to work, and how we will perform it; b) Movement Learning phase: theoretical and practical sessions with the explanation of movements and ergonomic basic patterns; and c) Physical Fitness Training phase: with training sessions aimed at improving fitness and weight loss, and training sessions focused on a correct pelvic mobilization for the delivery.The intensity will be adapted during the exercise program based on the week of gestation and each pregnant heart rate. The sessions will consist of a mixed work, composed of circuits where both muscular and cardiovascular conditioning will be implemented.

Control group

Intervention Type OTHER

Usual care, not exercise.

Placentraining

This is a retrospective study which purpose is to analyse the status of placentas of women participating in the GESTAFIT project, in which a concurrent physical exercise programme was developed. This rigorous design will allow us to test our central hypothesis that exercise during pregnancy will produce greater improvements in placental metabolic pathways associated with pregnancy complications, and is associated with better pregnancy and newborn outcomes.

Group Type EXPERIMENTAL

Exercise intervention

Intervention Type OTHER

The exercise intervention will be performed in two groups so that each group will have 12-13 participants.The groups will train 3 days/week (60min per session) from the 16th week of gestation until delivery. The exercise intervention group will go through different phases of training: a) Learning phase: which will involve the intervention plan, the goals we want to work, and how we will perform it; b) Movement Learning phase: theoretical and practical sessions with the explanation of movements and ergonomic basic patterns; and c) Physical Fitness Training phase: with training sessions aimed at improving fitness and weight loss, and training sessions focused on a correct pelvic mobilization for the delivery.The intensity will be adapted during the exercise program based on the week of gestation and each pregnant heart rate. The sessions will consist of a mixed work, composed of circuits where both muscular and cardiovascular conditioning will be implemented.

Control group

Intervention Type OTHER

Usual care, not exercise.

Interventions

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Exercise intervention

The exercise intervention will be performed in two groups so that each group will have 12-13 participants.The groups will train 3 days/week (60min per session) from the 16th week of gestation until delivery. The exercise intervention group will go through different phases of training: a) Learning phase: which will involve the intervention plan, the goals we want to work, and how we will perform it; b) Movement Learning phase: theoretical and practical sessions with the explanation of movements and ergonomic basic patterns; and c) Physical Fitness Training phase: with training sessions aimed at improving fitness and weight loss, and training sessions focused on a correct pelvic mobilization for the delivery.The intensity will be adapted during the exercise program based on the week of gestation and each pregnant heart rate. The sessions will consist of a mixed work, composed of circuits where both muscular and cardiovascular conditioning will be implemented.

Intervention Type OTHER

Control group

Usual care, not exercise.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Overweight pregnant woman with a normal pregnancy course.
* Answer "no" to all questions on the PARmed-X for pregnancy\*.
* To be able to walk without assistance.
* To be able to read and write enough.

Exclusion Criteria

* Acute or terminal illness.
* Malnutrition.
* Inability to conduct tests for assessing physical fitness or exercise during pregnancy.
* Underweight, normal-weight or obesity.
* Pregnancy risk factors (such as hypertension, type 2 diabetes, etc.).
* Multiple pregnancies.
* Chromosopathy or foetal malformations.
* Uterine growth restriction.
* Foetal death.
* Upper or lower extremity fracture in the past 3 months.
* Presence of neuromuscular disease or drugs affecting neuromuscular function
* Be registered in other exercise program
* Perform more than 300 minutes of at least moderate physical activity per week
* Unwillingness to either complete the study requirements or to be randomised into control or intervention group.

Minimum Eligible Age

25 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes