PregnancyNCT06722989
The Impact of Mobile Application-guided Physical Exercise on Physiological Parameters in Healthy Pregnant Women
A study testing mobile-guided exercise and Unguided physical activity in people with Pregnancy, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- mobile-guided exercise and Unguided physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSlovenia
- Study dates
- 10 Mar 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Impact of Mobile Application-guided Physical Exercise in Healthy Pregnant Women on Vital Physiological Parameters Measured with a Wearable Tracking Device
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.
Read the 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.
- Conditions
- Pregnancy
- Being tested
- mobile-guided exercise, Unguided physical activity
- Keywords
- pregnacy, physical activity, physical exercise, wearable tracking device, mobile guided exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mobile-guided exerciseBehavioural
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.
Unguided physical activityBehavioural
In this group, pregnant women will be physically active at their discretion.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: mobile-guided exercise |
| Unguided physical activity | Active comparator | In this arm, pregnant women will be physically active at their discretion. Receives: Behavioral: Unguided physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From enrolment to the end of treatment at 5 weeks.
Secondary outcomes (12)
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).
Measured: From enrolment to the end of treatment at 5 weeks.
Resting heart rate
Heart rate measured during sleep.
Measured: From enrolment to the end of treatment at 5 weeks.
Sleep duration
Overall duration of sleep and deep sleep duration.
Measured: 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.
Measured: At the enrolment and conclusion of the study after 5 weeks.
BMI z-score
Measure of Insulin sensitivity
Measured: At the enrolment and conclusion of the study after 5 weeks.
AST/ALT ratio
Measure of Insulin sensitivity
Measured: At the enrolment and conclusion of the study after 5 weeks.
Fasting triglycerides
Measure of Insulin sensitivity
Measured: At the enrolment and conclusion of the study after 5 weeks.
Fasting glucose
Measure of Insulin sensitivity
Measured: At the enrolment and conclusion of the study after 5 weeks.
Fasting HDL
Measure of Insulin sensitivity
Measured: At the enrolment and conclusion of the study after 5 weeks.
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Measure of Insulin sensitivity
Measured: At the enrolment and conclusion of the study after 5 weeks.
Single-Point Insulin Sensitivity Estimator (SPISE)
Measure of Insulin sensitivity
Measured: At the enrolment and conclusion of the study after 5 weeks.
Quantitative Insulin Sensitivity Check Index (QUICKI)
Measure of Insulin sensitivity
Measured: At the enrolment and conclusion of the study after 5 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start10 Mar 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tanja Premru-Srsen, University Medical Centre Ljubljana
- Investigators
- Tanja Premru-Srsen, MD, PhD, Principal investigator, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06722989
- Sponsor's protocol ID
- 0120-47/2024-2711-6
- Status last verified
- Mar 2025
- First submitted
- 15 Nov 2024
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be shared on request.
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Mobile Application-guided Physical Exercise in Healthy Pregnant Women on Vital Physiological Parameters Measured with a Wearable Tracking Device
- ClinicalTrials.gov ID
- NCT06722989
- Acronym / sponsor ID
- 0120-47/2024-2711-6
- Conditions
- Pregnancy
- Keywords
- pregnacy, physical activity, physical exercise, wearable tracking device, mobile guided exercise
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mobile-guided exercise group | Experimental | Behavioral: mobile-guided exerciseExercises 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. |
| Unguided physical activity | Active comparator | Behavioral: Unguided physical activityIn this arm, pregnant women will be physically active at their discretion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mobile-guided exerciseExercises 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. | Behavioural | mobile-guided exercise group |
| Unguided physical activityIn this group, pregnant women will be physically active at their discretion. | Behavioural | Unguided physical activity |
Primary outcome
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).
12 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Individual participant dataSharing planned: Yes. De-identified data will be shared on request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tanja Premru-Srsen, MD, PhD principal investigator
University Medical Centre Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mobile-guided exercise and Unguided physical activity in people with Pregnancy, run by University Medical Centre Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resting heart rate variability (time frame: From enrolment to the end of treatment at 5 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025; AzTrials last refreshed its copy on 1 Nov 2026.