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Educational Program on Exercise During Pregnancy (EDUPREG)

U

University of Oviedo

Status

Not yet enrolling

Conditions

Pregnancy

Treatments

Behavioral: Educational Session on Therapeutic Exercise During Pregnancy

Study type

Interventional

Funder types

Other

Identifiers

NCT07486999
EDU-EX-PREG-01

Details and patient eligibility

About

This study aims to evaluate whether a short educational session about safe therapeutic exercise during pregnancy can improve knowledge, confidence, and physical activity levels in pregnant women.

Although exercise during pregnancy is safe and beneficial, many women have doubts or lack information about how to exercise correctly. This can lead to low physical activity levels during pregnancy.

In this pilot randomized controlled trial, pregnant women attending primary care health centers will be invited to participate. After completing baseline questionnaires, participants will be randomly assigned to one of two groups. The control group will receive standard prenatal information provided during routine care. The experimental group will receive standard care plus a structured educational session about therapeutic exercise during pregnancy.

Participants will complete questionnaires measuring knowledge about exercise during pregnancy, confidence to exercise safely, and physical activity levels before the intervention and two weeks afterward.

The study is educational only. No mandatory physical exercise is required, and usual medical care will not be modified. The results will help determine whether brief educational interventions can support healthier lifestyles during pregnancy.

Full description

Regular physical activity during pregnancy is associated with multiple maternal and fetal health benefits. However, many pregnant women remain inactive due to lack of knowledge, misconceptions about safety, and low confidence to perform exercise. Educational strategies may help overcome these barriers, yet evidence on brief structured educational interventions in primary care settings remains limited.

This study is designed as a pilot randomized controlled trial to evaluate the feasibility and preliminary effectiveness of an educational intervention on therapeutic exercise during pregnancy.

Pregnant women between 24 and 36 weeks of gestation attending primary care health centers in the Principality of Asturias (Spain) will be invited to participate. Inclusion criteria include age ≥18 years, ability to understand Spanish, and low-risk pregnancy. Women with high-risk pregnancies, medical contraindications to exercise, or inability to complete online questionnaires will be excluded.

After providing informed consent, participants will complete baseline online questionnaires assessing:

Knowledge about exercise during pregnancy (Knowledge of Exercise during Pregnancy Scale - KEPS)

Exercise self-efficacy during pregnancy (adapted Pregnancy Exercise Self-Efficacy Scale)

Physical activity level (Pregnancy Physical Activity Questionnaire - PPAQ, Spanish validated version)

Participants will then be randomly assigned (1:1) to one of two groups:

Control group: Receives standard prenatal information routinely provided during midwife consultations.

Experimental group: Receives standard prenatal care plus a structured educational session delivered by a physiotherapist. The session lasts approximately 60 minutes and includes information on benefits and safety of exercise during pregnancy, recommendations on frequency and intensity, demonstration of adapted therapeutic exercises, and time for questions. The intervention is educational only and does not require mandatory physical exercise practice.

Two weeks after the intervention, all participants will complete the same questionnaires again.

Primary outcomes are changes in knowledge and exercise self-efficacy scores between baseline and follow-up. Secondary outcome is change in physical activity level measured by the PPAQ. As a pilot study, the planned sample size is 30-40 participants.

Data will be collected anonymously using coded identifiers. The study is considered minimal risk, as it involves only educational activities and questionnaire completion, without altering usual medical care.

Findings from this pilot trial will inform the feasibility of implementing structured educational interventions on exercise during pregnancy in primary care and provide preliminary data for future larger-scale studies.

Enrollment

30 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Pregnant women between 24 and 36 weeks of gestation
  • Age 18 years or older
  • Ability to understand Spanish
  • Low-risk pregnancy

Exclusion criteria

  • High-risk pregnancy
  • Medical contraindications to exercise during pregnancy
  • Inability to complete online questionnaires

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

Standard Prenatal Care
No Intervention group
Description:
Participants in this arm receive the usual prenatal information provided during routine midwife consultations, without any additional structured educational session on exercise.
Educational Intervention
Experimental group
Description:
Participants in this arm receive standard prenatal care plus a structured 60-minute educational session on therapeutic exercise during pregnancy delivered by a physiotherapist.
Treatment:
Behavioral: Educational Session on Therapeutic Exercise During Pregnancy

Trial contacts and locations

0

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Central trial contact

María Blanco Díaz, PhD.

Data sourced from clinicaltrials.gov

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