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

Overview

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.

Interventions

• 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
• Behavioral Unguided physical activity
  In this group, pregnant women will be physically active at their discretion.

Primary outcome measures

• Resting heart rate variability [Time frame: From enrolment to the end of treatment at 5 weeks.]

Secondary outcome measures (12)

• Resting cardiac coherence [Time frame: From enrolment to the end of treatment at 5 weeks.]
• Resting heart rate [Time frame: From enrolment to the end of treatment at 5 weeks.]
• Sleep duration [Time frame: From enrolment to the end of treatment at 5 weeks.]
• Systemic vascular resistance (SVR) [Time frame: At the enrolment and conclusion of the study after 5 weeks.]
• BMI z-score [Time frame: At the enrolment and conclusion of the study after 5 weeks.]
• AST/ALT ratio [Time frame: At the enrolment and conclusion of the study after 5 weeks.]
• Fasting triglycerides [Time frame: At the enrolment and conclusion of the study after 5 weeks.]
• Fasting glucose [Time frame: At the enrolment and conclusion of the study after 5 weeks.]
• Fasting HDL [Time frame: At the enrolment and conclusion of the study after 5 weeks.]
• Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) [Time frame: At the enrolment and conclusion of the study after 5 weeks.]
• Single-Point Insulin Sensitivity Estimator (SPISE) [Time frame: At the enrolment and conclusion of the study after 5 weeks.]
• Quantitative Insulin Sensitivity Check Index (QUICKI) [Time frame: At the enrolment and conclusion of the study after 5 weeks.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Basic science

Study locations

Slovenia · 1 center

• UMCLjubljana — Ljubljana

Identifiers

NCT: NCT06722989 · 0120-47/2024-2711-6

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗