NCT06722989

The Impact of Mobile Application-guided Physical Exercise on Physiological Parameters in Healthy Pregnant Women

The Impact of Mobile Application-guided Physical Exercise in Healthy Pregnant Women on Vital Physiological Parameters Measured with a Wearable Tracking Device

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University Medical Centre Ljubljana · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

After the second-trimester anomaly scan, healthy pregnant women will be offered inclusion in the study. Before inclusion, participants will fill out a questionnaire on the suitability of moderate physical exercise. After signing the consent form for the study, they will receive a random wrist-tracking device. The investigators will inform them about the use and possibilities of the wrist-tracking device. Suppose they will be randomly assigned to the group with a guided exercise program for pregnant women. In that case, they will also have a guided exercise program via a mobile application, where they will receive one of the exercises intended for pregnant women every day for up to 30 minutes. The investigators will also present and explain all the exercises to them, emphasizing the crucial role they play in our study. The investigators will also explain when they should stop exercising and immediately consult a perinatologist on the phone number provided. If they are randomly assigned to the control group, they will not receive exercise, but they can be physically active at their discretion.

Detailed description

The research will be a randomized intervention study on the impact of physical activity on physiological parameters and sleep duration during pregnancy. The research will be designed as a naturalistic study based on the guidelines for assessing the appropriateness of heart rate measurements with wrist-based heart rate monitors in biobehavioral research. The study will be conducted at the Gynecology Clinic at the University College of Medicine in Ljubljana.

Conditions

• Pregnancy

Interventions

Type	Name	Description
BEHAVIORAL	mobile-guided exercise	Exercises for pregnant women in the SG will fall into moderate physical activity. They will be previously assessed by a perinatologist with a license to guide exercise during pregnancy. Each exercise will last 30 minutes, including initial warm-up exercises and final stretching exercises. The recommended moderate activity for pregnant women is at least 150 minutes per week, achieved on at least three days. For pregnant women aged 29 years or less, this means within the limits of a heart rate of 125 to 146 beats/min. For pregnant women aged 30 years or more, it is within the limits of a heart rate of between 121 and 141 beats per minute. According to the Borg scale of perceived exertion from six to 20, moderate exercise is rated between 13 and 14, corresponding to the specified heart rate thresholds. The pregnant woman will rate her exercise on the Borg perceived exertion scale from six to 20. The recommended number of steps per day will be at least 6,000.
BEHAVIORAL	Unguided physical activity	In this group, pregnant women will be physically active at their discretion.

Timeline

• Start date: 2025-03-10
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2024-12-09
• Last updated: 2025-03-26

Locations

1 site across 1 country: Slovenia