RekrutujeFaza III
Badanie fazy III leku LY3502970
A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight
Badane leki: LY3502970
+2
+2W Polsce: RekrutujeNa świecie: Rekrutuje
Pęcherz nadreaktywny: badanie kliniczne
Tytuł w rejestrze: HIIT vs MICT During Pregnancy and Health and Birth Outcomes in Mothers and Children
Najważniejsze informacje
- Choroba
- Pęcherz nadreaktywny, Nadciśnienie tętnicze, Cukrzyca (Pregnancy, Postpartum, Childbirth, Health Status, Physical Fitness, Noncommunicable Diseases, Metabolism, Diabetes Mellitus, Gestational…)
- Status w Polsce
- Rekrutujestany polskich ośrodków według ClinicalTrials.gov
- Status na świecie
- Rekrutujestan całego badania w rejestrze
- Wiek uczestników
- 18-45 lat
- Płeć
- tylko kobiety
- Zdrowi ochotnicy
- tak
- Planowana liczba uczestników
- łącznie 600
- Terminy (planowane)
- 24 czerwca 2021 - 31 sierpnia 2031
- Kraje
- 1: Polska
- Numer w rejestrze
- NCT05009433 (ClinicalTrials.gov)
Gdzie prowadzone jest badanie
Ośrodki prowadzące badanie w Polsce (1), alfabetycznie według miejscowości:
- GdańskKontakt
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Cel badania
Opis z rejestru (w języku angielskim):
Regular exercise during pregnancy and postpartum leads to health benefits for mother and child. Inactivity during pregnancy and after delivery is now treated as risky behavior. Physically active pregnant women significantly less often suffer from, among others, gestational diabetes, excessive weight gain, lipids disorders, hypertension, preeclampsia, depressive symptoms, functional and structural disorders, including stress urinary incontinence, back pain or diastasis recti abdominis (DRA). Prenatal physical activity reduces the risk of premature delivery and miscarriage, fetal macrosomia, complications in labor or the risk of metabolic disorders in children.
High-intensity interval training (HIIT) has become one of the most popular trends in the fitness sector. The effectiveness of HIIT on a number of health indicators has been proven in various populations but limited data are available on HIIT during pregnancy.
The first hypothesis is that the HIIT, implemented during pregnancy and after childbirth, as a stronger exercise stimulus, will have a better impact on selected biological and psychological parameters of mothers, as well as on selected health parameters of their children, compared to the MICT (moderate intensity continuous training). Therefore, it promises better preventive effects on pregnancy complications and ailments as well as non-communicable diseases occurring in these populations. In the second hypothesis, it was assumed that HIIT and MICT implemented during pregnancy and after childbirth, tailored to the specific needs of the perinatal period, will not differ in the effectiveness of maintaining normal functional parameters in women, including prevention of urinary incontinence, back pain, DRA, etc.
Pregnant women who apply for the study will be divided into three groups: those attending the HIIT, MICT or educational programs. During the study, the participants will be under standard obstetric care. As comparative groups, non-pregnant women will be also recruited.
The investigators will collect data on selected biological, functional and psychological parameters in the study women at each trimester of pregnancy, during the puerperium and one year after childbirth. The data from the medical documentation on the course of childbirth and the assessment of the new-born, as well as the results of preventive examinations in the study women's children aged one, two, four and six years will be also analyzed.
Leczenie w badaniu
| Lek / interwencja | Rola | Postać, podanie |
|---|---|---|
| High intensity interval training program for pregnant women | Interwencja behawioralna | |
| Moderate intensity continuous training program for pregnant women | Interwencja behawioralna | |
| Standard obstetric care with extended education on healthy lifestyle | Interwencja behawioralna | |
| High intensity interval training program for nonpregnant women | Interwencja behawioralna | |
| Moderate intensity continuous training program for nonpregnant women | Interwencja behawioralna | |
| Standard health care with extended education on healthy lifestyle | Interwencja behawioralna |
Kryteria udziału
Kryteria w języku angielskim, tak jak w rejestrze.
Kryteria włączenia kto może wziąć udział (14)
- Criteria: Inclusion Criteria: For pregnant women:
- course of pregnancy allowing participation in physical activities adapted to pregnant women
- consent of the obstetric care provider to participate in the study tests and exercise classes;
- taking part in all diagnostic and control tests to assess selected biological, functional and psychological parameters at each trimester of pregnancy, during the puerperium and one year after childbirth;
- participant's consent to use data from the medical documentation on the course of childbirth and the assessment of the new-born, as well as the results of preventive examinations in children aged one, two, four and six, routinely performed according to the Polish pediatric care system;
- availability to participate in classes three times a week until the day of delivery;
- declaration of participation in postpartum classes at least once a week and self-completion of the exercise program according to written instructions prepared by the exercise specialist;
- women can participate in the exercise programs regardless of their level of fitness or exercise capacity, as well as the level of motor skills (based on the diagnostic exercise tests, the exercise program will be tailored to the individual needs and capabilities of a woman). For nonpregnant women:
- nulliparous;
- lack of diagnosed infertility and other disorders of the reproductive system;
- taking part in all diagnostic and control tests to assess selected biological, functional and psychological parameters at indicated time points: before and after each of the 8-week exercise program during the first 8 months of the study and once every 3 months during the following twelve months of the study
- declaration of availability to participate in exercise classes three times a week for the first 8 months of the program (attendance at least 80% is required);
- declaration of participation in classes at least once a week and self-completion of the exercise program to the required 150 minutes of physical activity per week, according to the written guidelines prepared by the instructor, for the next 12 months of the program;
- women can participate in the exercise program regardless of their level of fitness or exercise capacity, as well as the level of motor skills (based on the diagnostic exercise tests, the exercise program will be tailored to the individual needs and capabilities of a woman).
Kryteria wyłączenia kto nie może wziąć udziału (4)
- for Pregnant and Nonpregnant Women:
- contraindications to increased physical effort or to any of the diagnostic or control tests;
- allergies to materials used during diagnostic and control tests (e.g. nickel present in steel plates of vaginal electrodes, disinfectants);
- other conditions that, according to the researchers, will threaten the health or safety of the participants or will significantly affect the quality of the collected data.
To główne kryteria z rejestru. Pełną listę i ostateczną decyzję o udziale ustala lekarz prowadzący badanie.
Zapytaj o udział w tym badaniu
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