NCT07486999

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable pregnancy

Timeline
Completed

Started Feb 2026

Shorter than P25 for not_applicable pregnancy

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 17, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 23, 2026

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

March 23, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

March 17, 2026

Last Update Submit

March 17, 2026

Conditions

Keywords

Exercise during pregnancyTherapeutic exerciseEducational interventionSelf-efficacyPhysical activityPrenatal carePilot randomized trial

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Baseline and 2 weeks post-intervention

Study Arms (2)

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.

Behavioral: Educational Session on Therapeutic Exercise During Pregnancy

Interventions

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.

Educational Intervention

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

María Blanco Díaz, PhD.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 17, 2026

First Posted

March 23, 2026

Study Start

February 1, 2026

Primary Completion

April 1, 2026

Study Completion

May 1, 2026

Last Updated

March 23, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share