Educational Program on Exercise During Pregnancy (EDUPREG)

March 17, 2026 updated by: Maria Blanco Diaz, University of Oviedo

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 2 weeks post-intervention
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.
Baseline and 2 weeks post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oviedo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

March 17, 2026

First Submitted That Met QC Criteria

March 17, 2026

First Posted (Actual)

March 23, 2026

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EDU-EX-PREG-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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