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

Not Applicable

• Conditions: Pregnancy

• Registration Number: NCT06722989
• Lead Sponsor: University Medical Centre Ljubljana

Brief 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.

Study Timeline

• Study First Submitted: 2024-11-15
• Study First Submitted QC: 2024-12-03
• Study First Posted: 2024-12-09
• Status Verified: 2025-03
• Study Start: 2025-03-10
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-26
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• age ≥ 18 years,
• confirmed duration of pregnancy with ultrasound measurement between the crown and the coccyx of the fetus in the first trimester,
• legal capacity,
• understanding of the Slovenian and English languages,
• signed consent form for the study, access to encrypted data, and use of data according to GDPR.

Exclusion Criteria

pregnant women who will not sign a consent form for the study and the GDPR.

• pregnant women who will not allow the use of the key to access encrypted measurement data

• women under the influence of illegal substances (drugs or alcohol) that may interfere with their ability to participate and comply with the investigation procedures,

• any acute or chronic disease, disorder or condition, including cognitive dysfunction,

• pregnant women with multiple pregnancies,

• pregnant women with conditions that constitute a contraindication to regular physical exercise during pregnancy:

  • with a cervix < 30 mm,
  • with persistent unexplained bloody discharge,
  • with a placenta < 30 mm from the internal os,
  • with a growth-restricted fetus,
  • with rupture of the amniotic sac,
  • with a previous premature birth < 32 weeks,
  • with recurrent miscarriages
  • with one or more affirmative answers in the self-assessment questionnaire for physical fitness.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Resting heart rate variability	From enrolment to the end of treatment at 5 weeks.	Heart rate variability (HRV) refers to the change in the interval between two beats (beat-to-beat interval) and allows a non-invasive assessment of the balance between the cardiac sympathetic and parasympathetic nervous systems. It will be measured during rest (sleep).

Secondary Outcome Measures

Name	Time	Method
Sleep duration	From enrolment to the end of treatment at 5 weeks.	Overall duration of sleep and deep sleep duration.
Resting cardiac coherence	From enrolment to the end of treatment at 5 weeks.	Cardiac coherence, or physiological coherence, describes a measure of the stability and harmony of individual oscillatory regulatory systems in the body at any given time. It is reflected in the regular, sine-wave pattern of the heartbeat. It will be measured during rest (sleep).
Resting heart rate	From enrolment to the end of treatment at 5 weeks.	Heart rate measured during sleep.
Systemic vascular resistance (SVR)	At the enrolment and conclusion of the study after 5 weeks.	Systemic vascular resistance is the quantitative value for left ventricular afterload. In most patients, changes in vascular resistance reflect changes in arteriolar tone or changes in the viscosity of blood. It will be measured by USCOM.
BMI z-score	At the enrolment and conclusion of the study after 5 weeks.	Measure of Insulin sensitivity
AST/ALT ratio	At the enrolment and conclusion of the study after 5 weeks.	Measure of Insulin sensitivity
Fasting triglycerides	At the enrolment and conclusion of the study after 5 weeks.	Measure of Insulin sensitivity
Fasting glucose	At the enrolment and conclusion of the study after 5 weeks.	Measure of Insulin sensitivity
Fasting HDL	At the enrolment and conclusion of the study after 5 weeks.	Measure of Insulin sensitivity
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)	At the enrolment and conclusion of the study after 5 weeks.	Measure of Insulin sensitivity
Single-Point Insulin Sensitivity Estimator (SPISE)	At the enrolment and conclusion of the study after 5 weeks.	Measure of Insulin sensitivity
Quantitative Insulin Sensitivity Check Index (QUICKI)	At the enrolment and conclusion of the study after 5 weeks.	Measure of Insulin sensitivity

Trial Locations

Locations (1)

UMCLjubljana; 🇸🇮 Ljubljana, Slovenia