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NCT Number: NCT07486999

Educational Program on Exercise During Pregnancy

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Educational Session on Therapeutic Exercise During Pregnancy

Behavioral

A structured 60-minute group educational session including information on benefits and safety of exercise during pregnancy, recommendations for frequency and intensity, demonstration of adapted therapeutic exercises, and a question-and-answer period.

Primary outcomes

  1. Knowledge about exercise during pregnancy

    Time frame: Baseline and 2 weeks post-intervention

    Change in knowledge regarding exercise during pregnancy measured using the Knowledge of Exercise during Pregnancy Scale (KEPS). Scores range from low to high knowledge. The difference between baseline and 2-week follow-up will be analyzed.

  2. Exercise self-efficacy during pregnancy

    Time frame: Baseline and 2 weeks post-intervention

    Change in confidence to perform safe exercise during pregnancy measured using an adapted Pregnancy Exercise Self-Efficacy Scale. Scores range from low to high self-efficacy. The difference between baseline and 2-week follow-up will be analyzed.

Study contacts

Contact information is provided by the study sponsor or research team.

María Blanco Díaz, PhD.

CONTACT

[email protected]

+34667681858

Sponsors and collaborators

Lead sponsor

University of Oviedo

Other

Registry information

Official study title

Educational Intervention on Therapeutic Exercise During Pregnancy: A Pilot Randomized Controlled Trial

Acronym: EDUPREG

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 23, 2026
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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