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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

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

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Фундаментальное исследование

Центры проведения

Словения · 1 центр

• UMCLjubljana — Ljubljana

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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