PregnancyEDUPREGNCT07486999
Educational Program on Exercise During Pregnancy
A study testing Educational Session on Therapeutic Exercise During Pregnancy in people with Pregnancy, run by University of Oviedo.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Educational Session on Therapeutic Exercise During Pregnancy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Feb 2026to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant women between 24 and 36 weeks of gestation
- Age 18 years or older
- Ability to understand Spanish
- Low-risk pregnancy
Who cannot join
- High-risk pregnancy
- Medical contraindications to exercise during pregnancy
- Inability to complete online questionnaires
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Pregnancy
- Being tested
- Educational Session on Therapeutic Exercise During Pregnancy
- Keywords
- Exercise during pregnancy, Therapeutic exercise, Educational intervention, Self-efficacy, Physical activity, Prenatal care, Pilot randomized trial
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational Session on Therapeutic Exercise During PregnancyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Prenatal Care | No intervention | 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 | Participants in this arm receive standard prenatal care plus a structured 60-minute educational session on therapeutic exercise during pregnancy delivered by a physiotherapist. Receives: Behavioral: Educational Session on Therapeutic Exercise During Pregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge about exercise during pregnancy
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.
Measured: Baseline and 2 weeks post-intervention
Exercise self-efficacy during pregnancy
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.
Measured: Baseline and 2 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study startFeb 2026 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to either a control group receiving standard prenatal information or an experimental group receiving standard care plus an educational intervention on therapeutic exercise during pregnancy.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oviedo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Blanco Diaz, University of Oviedo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07486999
- Sponsor's protocol ID
- EDU-EX-PREG-01
- Acronym
- EDUPREG
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Educational Intervention on Therapeutic Exercise During Pregnancy: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07486999
- Acronym / sponsor ID
- EDUPREG / EDU-EX-PREG-01
- Conditions
- Pregnancy
- Keywords
- Exercise during pregnancy, Therapeutic exercise, Educational intervention, Self-efficacy, Physical activity, Prenatal care, Pilot randomized trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of OviedoUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 23 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to either a control group receiving standard prenatal information or an experimental group receiving standard care plus an educational intervention on therapeutic exercise during pregnancy.
| Arm | Type | Receives |
|---|---|---|
| Standard Prenatal Care | No intervention | –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 | Behavioral: Educational Session on Therapeutic Exercise During PregnancyParticipants in this arm receive standard prenatal care plus a structured 60-minute educational session on therapeutic exercise during pregnancy delivered by a physiotherapist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pregnant women between 24 and 36 weeks of gestation
- Age 18 years or older
- Ability to understand Spanish
- Low-risk pregnancy
Key exclusion criteria (3 listed)
- High-risk pregnancy
- Medical contraindications to exercise during pregnancy
- Inability to complete online questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational Session on Therapeutic Exercise During PregnancyA 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. | Behavioural | Educational Intervention |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Session on Therapeutic Exercise During Pregnancy in people with Pregnancy, run by University of Oviedo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact María Blanco Díaz, PhD. (+34667681858, blancomaria@uniovi.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge about exercise during pregnancy (time frame: Baseline and 2 weeks post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.