The Impact of Mobile Application-guided Physical Exercise in Healthy Pregnant Women on Vital Physiological Parameters Measured with a Wearable Tracking Device
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Resting heart rate variability
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
mobile-guided exercise group
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.
干预措施: mobile-guided exercise (Behavioral)
Unguided physical activity
In this arm, pregnant women will be physically active at their discretion.
干预措施: Unguided physical activity (Behavioral)
结局指标
主要结局
Resting heart rate variability
时间窗: 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).
次要结局
- BMI z-score(At the enrolment and conclusion of the study after 5 weeks.)
- 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.)
- AST/ALT ratio(At the enrolment and conclusion of the study after 5 weeks.)
- Fasting triglycerides(At the enrolment and conclusion of the study after 5 weeks.)
- Fasting glucose(At the enrolment and conclusion of the study after 5 weeks.)
- Fasting HDL(At the enrolment and conclusion of the study after 5 weeks.)
- Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)(At the enrolment and conclusion of the study after 5 weeks.)
- Single-Point Insulin Sensitivity Estimator (SPISE)(At the enrolment and conclusion of the study after 5 weeks.)
- Quantitative Insulin Sensitivity Check Index (QUICKI)(At the enrolment and conclusion of the study after 5 weeks.)
研究者
Tanja Premru-Srsen
Assoc. Prof.
University Medical Centre Ljubljana