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Résztvevőt keres itt: LengyelországFázis nélkül

HIIT vs MICT During Pregnancy and Health and Birth Outcomes in Mothers and Children

A legfontosabb adatok

Ki végzi
Gdansk University of Physical Education and Sport
Hol
Gdansk (Lengyelország)A helyszín megnézése
Azonosító
Állapot
Toboroz
Résztvevők
600 fő, tervezett
Kezdés
2021. jún. 24.
Várható befejezés
2031. aug. 31.
A vizsgálat típusa
Beavatkozással járó, 6 csoportAz egyik csoport egy már használt kezelést kap, összehasonlításként.
A vizsgált kezelések
  • High intensity interval training program for pregnant women
  • Moderate intensity continuous training program for pregnant women
  • Standard obstetric care with extended education on healthy lifestyle
  • High intensity interval training program for nonpregnant women
  • Moderate intensity continuous training program for nonpregnant women
  • Standard health care with extended education on healthy lifestyle
A regiszteradat frissítve
2022. december 2.

Ki vehet részt

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

A vizsgálat terhes nőket, valamint olyan nem terhes nőket keres, akik még nem szültek, edzésprogramokban és egészségügyi vizsgálatokon való részvételre.

Életkor
18–45 év
Nem
Csak nők
A betegség stádiuma
A terhes nőknél a terhesség lefolyásának lehetővé kell tennie a terhesekre szabott testmozgást. A nem terhes nőknél nem lehet diagnosztizált meddőség vagy más a szaporodási rendszert érintő betegség.

A részvétel fő kizáró okai

  • Olyan ok, amely miatt a nagyobb fizikai megterhelés vagy bármelyik vizsgálat nem biztonságos
  • Allergia a vizsgálatokhoz használt anyagokra, például a nikkelre vagy a fertőtlenítőszerekre
  • Más olyan állapot, amely a kutatók szerint veszélyeztetné az egészséget vagy a biztonságot, vagy rontaná az adatok minőségét
  • Nem terhes nők, akik már szültek

A regiszter feltételei, szó szerint

Mind a 18 feltétel megnézéseKevesebb

Ki vehet részt

  • 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)

Ki nem vehet részt

  • 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
  • contraindications to increased physical effort or to any of the diagnostic or control tests

Nézd meg, megfelelhetsz-e

Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.

  • 18 és 45 év között vagy?

Helyszínek itt: Lengyelország

  • Laboratory of Physical Effort and Genetics in Sport at Gdansk University of Physical Education and SportGdansk, LengyelországContact: Anna N Szumilewicz, Assoc. Prof.Résztvevőt keres

A vizsgálatról

Mit akar kideríteni a vizsgálat

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.

A teljes eredeti leírásKevesebb

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.

A vizsgálat 6 csoportja

  • Pregnant HIIT groupA vizsgált kezelés

    The high intensity interval training (HIIT) program will be implemented according to the World Health Organization guidelines on physical activity and sedentary behavior (2020) and on the recommendations on physical activity and exercise during pregnancy and postpartum period published by the American College of Obstetricians and Gynecologists (2020). The program will be also based on the "High-Intensity Interval Training for Cardiometabolic Disease Prevention" report by American College of Sports Medicine (2019). During the study, the participant will be under standard obstetric care on her own. She is obliged to inform her obstetric care provider about participation in the HIIT program and to provide feedback to the project coordinator as to possible recommendations of the obstetric care provider regarding the exercise.

    Kezelés: High intensity interval training program for pregnant women

  • Pregnant MICT groupMár használt kezelés, összehasonlításként

    The moderate intensity continuous training (MICT) program will be implemented based on the World Health Organization guidelines on physical activity and sedentary behavior (2020) and on the recommendations on physical activity and exercise during pregnancy and postpartum period published by the American College of Obstetricians and Gynecologists (2020). During the study, the participant will be under standard obstetric care on her own. She is obliged to inform her obstetric care provider about participation in the MICT program and to provide feedback to the project coordinator as to possible recommendations of the obstetric care provider regarding the exercise.

    Kezelés: Moderate intensity continuous training program for pregnant women

  • Pregnant standard care groupSzínlelt kezelés, összehasonlításként

    During the study, the participant will be under standard obstetric care on her own. She is obliged to inform her obstetric care provider about participation in the HIIT Mama study and to provide feedback to the project coordinator as to possible contraindications to taking part in the study tests.

    Kezelés: Standard obstetric care with extended education on healthy lifestyle

  • Nonpregnant HIIT groupA vizsgált kezelés

    The high intensity interval training (HIIT) program will be implemented according to the World Health Organization guidelines on physical activity and sedentary behavior (2020) and on the "High-Intensity Interval Training for Cardiometabolic Disease Prevention" report by American College of Sports Medicine (2019). During the study, the participant will be under standard health care on her own. She is obliged to inform her health care provider about participation in the HIIT Mama study and to provide feedback to the project coordinator as to possible contraindications to exercise or taking part in the study tests.

    Kezelés: High intensity interval training program for nonpregnant women

  • Nonpregnant MICT groupMár használt kezelés, összehasonlításként

    The moderate intensity continuous training program will be implemented according to the World Health Organization guidelines on physical activity and sedentary behavior (2020). During the study, the participant will be under standard health care on her own. She is obliged to inform her health care provider about participation in the HIIT Mama study and to provide feedback to the project coordinator as to possible contraindications to exercise or taking part in the study tests.

    Kezelés: Moderate intensity continuous training program for nonpregnant women

  • Nonpregnant standard care groupSzínlelt kezelés, összehasonlításként

    During the study, the participant will be under standard health care on her own. She is obliged to inform her health care provider about participation in the HIIT Mama study and to provide feedback to the project coordinator as to possible contraindications to exercise or taking part in the study tests.

    Kezelés: Standard health care with extended education on healthy lifestyle

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
The Effect of Pre- and Postnatal High Intensity Interval Training and Moderate Intensity Continuous Training on Biological, Functional and Psychological Markers of Pregnancy Disorders and Non-communicable Diseases in Mothers and Offsprings
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 12.
Illeszkedési kérdések
Forrás: NCT05009433: ki vehet részt
A regiszteradat frissítve
2022. december 2.