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

NCT06722989 | Enrolling By Invitation

• 1 other identifier: 0120-47/2024-2711-6
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy

Keywords

pregnacy; physical activity; physical exercise; wearable tracking device; mobile guided exercise

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (12)

• Resting cardiac coherence

  From enrolment to the end of treatment at 5 weeks.

• 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.

• 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.

Study Arms (2)

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.

Behavioral: mobile-guided exercise

Unguided physical activity

ACTIVE COMPARATOR

In this arm, pregnant women will be physically active at their discretion.

Behavioral: Unguided physical activity

Interventions

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.

mobile-guided exercise group

Unguided physical activity BEHAVIORAL

In this group, pregnant women will be physically active at their discretion.

Unguided physical activity

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

UMCLjubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Tanja Premru-Srsen, MD, PhD

  University Medical Centre Ljubljana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: December 9, 2024
• Study Start: March 10, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: From study completion.
• Access Criteria: Upon request and review of the request.

Locations

SL (1)