Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Effects of Regular Exercise During Pregnancy

Training During Pregnancy - Effects of Regular Exercise During Pregnancy in Prevention of Pregnancy-related Diseases and Complications During Labour. A Randomised Clinical Trial

There is a great lack of results from randomized clinical trials with high methodological quality, assessing the effects of exercise during pregnancy. The main aims of this trial is to study the effects of exercise during pregnancy in the prevention and treatment of disease and complications which may arise during pregnancy:

  • Does regular exercise during pregnancy aid in preventing gestational diabetes?
  • Does regular exercise during pregnancy prevent low back and/or pelvic girdle pain?
  • Does regular exercise during pregnancy prevent urine and/or fecal incontinence?
  • Does regular exercise during pregnancy have an effect on labour and delivery?
  • Does regular exercise during pregnancy prevent maternal excessive weight gain and fetal macrosomatia?

Studieoversigt

Detaljeret beskrivelse

Pregnancy is regarded as a period of high risk when it comes to development of e.g. excessive weight gain, gestational diabetes and musculoskeletal problems such as low back pain and pelvic girdle pain, and urinary and fecal incontinence. While pregnancy and labor imply these and other risks, exercise is regarded as advantageous during pregnancy. Today's knowledge about the importance of exercise during pregnancy is mainly based on observational data from epidemiological studies, and the scientific strength of the clinical recommendations given is open to question. There is a great lack of results from randomized clinical trials with high methodological quality, assessing the effects of exercise during pregnancy. As a result of this, many important questions are still not answered. One of these is the effect exercise during pregnancy has in the prevention and treatment of disease and complications which may arise during pregnancy. Another question is the consequences that exercise during pregnancy has for labor and delivery. This study is designed as a randomized clinical trial using validated measurement tools to find answers to the mentioned questions.

In both national and international literature the importance of physical activity is highlighted. WHO has recently presented a global strategy for nutrition, physical activity and health. In Norway physical activity and exercise have been strongly addressed, and is an issue of high priority also in pregnant and postpartum women (St.meld.nr.16). Nevertheless, few trials evaluating the effects of regular exercise have been published. There is a need for evidence based knowledge to be implemented in education of health professionals, and in the development of health promotion strategies aiming at the general population.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

855

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Trondheim, Norge, 7489
        • Department of Community Medicine and General Practice, Norwegian University of Science and Technology and Clinical Service, St Olavs Hospital, Trondheim University Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  • Pregnant 18 weeks
  • attend the routine ultrasound control at the three hospitals
  • healthy
  • age 18 years or more
  • singleton live foetus at the routine ultrasound scan
  • normal pregnancy.

Exclusion Criteria:

  • pregnancy complications
  • high risk for preterm labour
  • pain during pelvic floor muscle contractions
  • ongoing urinary tract infection
  • diseases that could interfere with participation (following recommendations from SEF 2000, ACOG 2003)
  • living too far from the hospitals to be able to attend weekly exercise groups

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: exercise
Regular exercise 45-60 minutes minimum three times per week
a specific training program 12 weeks between pregnancy week 20 and 36. regular exercise 45-60 minutes minimum three times per week.
Andre navne:
  • fysioterapi
  • regular training
  • specific exercises
Aktiv komparator: control
standard antenatal care
standard antenatal care

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Gestational diabetes
Tidsramme: 20 and 36 weeks pregnancy and 3 months post partum
insulin resistance
20 and 36 weeks pregnancy and 3 months post partum
Gestational diabetes
Tidsramme: 18 months postpartum
Insulin resistance
18 months postpartum

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
incontinence
Tidsramme: 20 and 36 weeks of pregnancy, 3 months post partum
Fecal- and urinary incontinence (incontinence scores)
20 and 36 weeks of pregnancy, 3 months post partum
lumbopelvic pain
Tidsramme: 20 and 36 weeks pregnancy and 3 months post partum
Lumbopelvic pain (Pain intensity 100mm Visual Analogue Scale)
20 and 36 weeks pregnancy and 3 months post partum
disability
Tidsramme: 20 and 36 weeks pregnancy and 3 months post partum
Disability Rating Index (Salèn et al. 1994)
20 and 36 weeks pregnancy and 3 months post partum
incontinence
Tidsramme: 18 months postpartum
Fecal- and urinary incontinence (incontinence scores)
18 months postpartum
lumbopelvic pain
Tidsramme: 18 months postpartum
Lumbopelvic pain (Pain intensity 100mm Visual Analogue Scale)
18 months postpartum
disability
Tidsramme: 18 months postpartum
Disability Rating Index (Salèn et al. 1994)
18 months postpartum
Gestational diabetes
Tidsramme: 5 years
insulin resistance
5 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Studiestol: Siv Mørkved, PhD, Norwegian University of Science and Technology

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. maj 2007

Primær færdiggørelse (Faktiske)

1. juni 2011

Studieafslutning (Faktiske)

1. juni 2015

Datoer for studieregistrering

Først indsendt

21. maj 2007

Først indsendt, der opfyldte QC-kriterier

21. maj 2007

Først opslået (Skøn)

22. maj 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. oktober 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. oktober 2020

Sidst verificeret

1. oktober 2020

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • REK4.2007.81

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner