The Impact of Mobile Application-guided Physical Exercise in Healthy Pregnant Women on Vital Physiological Parameters Measured with a Wearable Tracking Device
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pregnancy
- Sponsor
- University Medical Centre Ljubljana
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Resting heart rate variability
- Status
- Enrolling By Invitation
- Last Updated
- last year
Overview
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.
Investigators
Tanja Premru-Srsen
Assoc. Prof.
University Medical Centre 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,
Outcomes
Primary Outcomes
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
- Resting heart rate(From enrolment to the end of treatment at 5 weeks.)
- Sleep duration(From enrolment to the end of treatment at 5 weeks.)
- Resting cardiac coherence(From enrolment to the end of treatment at 5 weeks.)
- Systemic vascular resistance (SVR)(At the enrolment and conclusion of the study after 5 weeks.)
- BMI z-score(At the enrolment and conclusion of the study after 5 weeks.)
- AST/ALT ratio(At the enrolment and conclusion of the study after 5 weeks.)
- Fasting triglycerides(At the enrolment and conclusion of the study after 5 weeks.)
- Fasting glucose(At the enrolment and conclusion of the study after 5 weeks.)
- Fasting HDL(At the enrolment and conclusion of the study after 5 weeks.)
- Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)(At the enrolment and conclusion of the study after 5 weeks.)
- Single-Point Insulin Sensitivity Estimator (SPISE)(At the enrolment and conclusion of the study after 5 weeks.)
- Quantitative Insulin Sensitivity Check Index (QUICKI)(At the enrolment and conclusion of the study after 5 weeks.)