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Enrolling by Invitation

NCT Number: NCT06722989

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

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.

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Key information

Conditions

Pregnancy Behavior Motor Activity

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UMCLjubljana

Ljubljana, 1000, Slovenia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

mobile-guided exercise

Behavioral

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.

Unguided physical activity

Behavioral

In this group, pregnant women will be physically active at their discretion.

Primary outcomes

  1. Resting heart rate variability

    Time frame: 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 outcomes

  1. Resting cardiac coherence

    Time frame: 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).

  2. Resting heart rate

    Time frame: From enrolment to the end of treatment at 5 weeks.

    Heart rate measured during sleep.

  3. Sleep duration

    Time frame: From enrolment to the end of treatment at 5 weeks.

    Overall duration of sleep and deep sleep duration.

  4. Systemic vascular resistance (SVR)

    Time frame: 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.

  5. BMI z-score

    Time frame: At the enrolment and conclusion of the study after 5 weeks.

    Measure of Insulin sensitivity

  6. AST/ALT ratio

    Time frame: At the enrolment and conclusion of the study after 5 weeks.

    Measure of Insulin sensitivity

  7. Fasting triglycerides

    Time frame: At the enrolment and conclusion of the study after 5 weeks.

    Measure of Insulin sensitivity

  8. Fasting glucose

    Time frame: At the enrolment and conclusion of the study after 5 weeks.

    Measure of Insulin sensitivity

  9. Fasting HDL

    Time frame: At the enrolment and conclusion of the study after 5 weeks.

    Measure of Insulin sensitivity

  10. Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)

    Time frame: At the enrolment and conclusion of the study after 5 weeks.

    Measure of Insulin sensitivity

  11. Single-Point Insulin Sensitivity Estimator (SPISE)

    Time frame: At the enrolment and conclusion of the study after 5 weeks.

    Measure of Insulin sensitivity

  12. Quantitative Insulin Sensitivity Check Index (QUICKI)

    Time frame: At the enrolment and conclusion of the study after 5 weeks.

    Measure of Insulin sensitivity

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 9, 2024
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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