NCT06954454: ActivePregnanc

Impact of In-Person Versus Online Supervised Multicenter Multicomponent Prenatal Exercise Program on Maternal Physical Activity, Fitness, and Healthy Lifestyle

Recruiting now NA Last updated 4 June 2025

What this trial tests

NA trial testing prenatal physical exercise intervention in Pregnant Women Participating in a Supervised Multicomponent Exercise Intervention in 250 participants. Currently enrolling.

Timeline

24 April 2025

Primary endpoint
24 October 2026

24 April 2027

Quick facts

Lead sponsor	Polytechnic University of Santarém
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	250
Start date	24 April 2025
Primary completion	24 October 2026
Estimated completion	24 April 2027
Sites	3 locations across Portugal

Drugs / interventions tested

• prenatal physical exercise intervention

Conditions studied

• Pregnant Women Participating in a Supervised Multicomponent Exercise Intervention — all drugs for Pregnant Women Participating in a Supervised Multicomponent Exercise Intervention →

Sponsor

Polytechnic University of Santarém

Who can join

Adults 18 to 50, female only, with Pregnant Women Participating in a Supervised Multicomponent Exercise Intervention. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Many studies have been supporting the positive effects of an active lifestyle concerning the prevention and treatment of pregnancy-related complications and health problems, such as gestational diabetes, gestational hypertension, obesity, low back pain, urinary incontinence, anxiety or depression, as well as regarding its effectiveness in maintaining fitness and functionality, and in improving postpartum recovery.

Practice and clinical guidelines have become increasingly popular tools for synthesizing evidence-based information to assist practitioners and patients/participants in making decisions related to starting or continuing physical activity.

Despite this knowledge, most women still do not receive proper guidance on how to exercise during pregnancy or after childbirth, and the prevalence of physical inactivity is still high among pregnant and postpartum women. On the other hand, the COVID-19 pandemic has highlighted the need for virtual approaches in health interventions, but few studies have addressed the effectiveness of such interventions.

This study is about the benefits of exercising during pregnancy in terms of maternal physical activity, fitness, and healthy lifestyle parameters. After the first visit to the doctor, pregnant women without absolute contraindications to exercise will be invited to participate in a multi-site (fitness center, university, or hospital) prenatal exercise program delivered either in person or online by qualified exercise physiologists.

The exercise intervention will follow international evidence-based guidelines. It includes aerobic, coordination, strength, postural, stretching, and pelvic floor exercises, organized in two weekly sessions lasting 60 minutes each.

Pregnant women will be asked to answer questionnaires about physical activity, fitness, and healthy lifestyle parameters (sleep, diet, stress) twice: before starting the exercise program and after completing 12 weeks of the program. The same procedure applies to basic fitness field tests (e.g., to assess balance, flexibility, strength, cardiorespiratory fitness, etc.).

Participants will have access to the free Active Pregnancy Guide (including recommendations for walking, dancing, swimming, etc.). On other days of the week, they can follow specific workouts on the YouTube channel (@GravidezAtiva-ActivePregnancy).

Researchers will test whether the exercise program is beneficial in maintaining or improving maternal physical activity and fitness levels and healthy lifestyle parameters after 12 weeks. Moreover, researchers will compare which exercise mode (in-person or virtual) is better or similar. Participants will also be asked about their satisfaction with the intervention and educational resources. Participation and resources will be free. All participants will benefit from the exercise intervention.

The study's results will contribute to knowledge on this topic, inform future exercise recommendations for pregnant women, and inform public health strategies.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Impact of in-person versus online supervised multicentre multicomponent prenatal exercise programme on maternal physical activity, fitness and healthy lifestyle: the Active Pregnancy trial SPIRIT 2025-based protocol.
   Santos-Rocha R, Branco M, Prior de Freitas J, Castro B, et al · · 2025 · PMID 40657545 · DOI 10.1136/bmjsem-2025-002767