Clinical trial NCT06722989: The Impact of Mobile Application-guided Physical Exercise on Physiological Parameters in Healthy Pregnant Women
Official title: The Impact of Mobile Application-guided Physical Exercise in Healthy Pregnant Women on Vital Physiological Parameters Measured with a Wearable Tracking Device
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Pregnancy
Keywords: pregnacy
physical activity
physical exercise
wearable tracking device
mobile guided exercise
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2024-12-09
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Resting heart rate variability
timeFrame: From enrolment to the end of treatment at 5 weeks.
Secondary outcomes:
measure: Resting cardiac coherence
timeFrame: From enrolment to the end of treatment at 5 weeks.
measure: Resting heart rate
timeFrame: From enrolment to the end of treatment at 5 weeks.
measure: Sleep duration
timeFrame: From enrolment to the end of treatment at 5 weeks.
measure: Systemic vascular resistance (SVR)
timeFrame: At the enrolment and conclusion of the study after 5 weeks.
measure: BMI z-score
timeFrame: At the enrolment and conclusion of the study after 5 weeks.
measure: AST/ALT ratio
timeFrame: At the enrolment and conclusion of the study after 5 weeks.
measure: Fasting triglycerides
timeFrame: At the enrolment and conclusion of the study after 5 weeks.
measure: Fasting glucose
timeFrame: At the enrolment and conclusion of the study after 5 weeks.
measure: Fasting HDL
timeFrame: At the enrolment and conclusion of the study after 5 weeks.
measure: Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
timeFrame: At the enrolment and conclusion of the study after 5 weeks.
measure: Single-Point Insulin Sensitivity Estimator (SPISE)
timeFrame: At the enrolment and conclusion of the study after 5 weeks.
measure: Quantitative Insulin Sensitivity Check Index (QUICKI)
timeFrame: At the enrolment and conclusion of the study after 5 weeks.
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: UMCLjubljana
Study officials:
affiliation: University Medical Centre Ljubljana
name: Tanja Premru-Srsen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: