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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mobile-guided exercise group | Experimental | 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. |
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| Unguided physical activity | Active Comparator | In this arm, pregnant women will be physically active at their discretion. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Resting heart rate variability | 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). | From enrolment to the end of treatment at 5 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Resting cardiac coherence | 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). | From enrolment to the end of treatment at 5 weeks. |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Tanja Premru-Srsen, MD, PhD | University Medical Centre Ljubljana | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMCLjubljana | Ljubljana | 1000 | Slovenia |
De-identified data will be shared on request.
From study completion.
Upon request and review of the request.
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| Unguided physical activity | Behavioral | In this group, pregnant women will be physically active at their discretion. |
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| Resting heart rate | Heart rate measured during sleep. | From enrolment to the end of treatment at 5 weeks. |
| Sleep duration | Overall duration of sleep and deep sleep duration. | From enrolment to the end of treatment at 5 weeks. |
| Systemic vascular resistance (SVR) | 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. | At the enrolment and conclusion of the study after 5 weeks. |
| BMI z-score | Measure of Insulin sensitivity | At the enrolment and conclusion of the study after 5 weeks. |
| AST/ALT ratio | Measure of Insulin sensitivity | At the enrolment and conclusion of the study after 5 weeks. |
| Fasting triglycerides | Measure of Insulin sensitivity | At the enrolment and conclusion of the study after 5 weeks. |
| Fasting glucose | Measure of Insulin sensitivity | At the enrolment and conclusion of the study after 5 weeks. |
| Fasting HDL | Measure of Insulin sensitivity | At the enrolment and conclusion of the study after 5 weeks. |
| Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) | Measure of Insulin sensitivity | At the enrolment and conclusion of the study after 5 weeks. |
| Single-Point Insulin Sensitivity Estimator (SPISE) | Measure of Insulin sensitivity | At the enrolment and conclusion of the study after 5 weeks. |
| Quantitative Insulin Sensitivity Check Index (QUICKI) | Measure of Insulin sensitivity | At the enrolment and conclusion of the study after 5 weeks. |