- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01477372
Effect of Physical Exercise Program During Pregnancy on Excessive Weight Gain and Its Consequences
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
BACKROUND: Pregnancy and delivery can condition significantly women's health. In particular, an excessive gain of weight during pregnancy constitutes a risk factor which may lead to (i) different alterations during pregnancy such as gestational diabetes or hypertension, (ii) foetus health problems (macrosomia), (iii) delivery complications (dystocia, prolonged labour and increased number of caesareans) and (iv) future health disorders for the woman (overweight, obesity and cardiovascular alterations). Furthermore, during pregnancy pelvic floor health problems, such as urinary incontinence (IU) may arise or worsen.
OBJECTIVES: The main aim of this study was to assess the effectiveness of a moderate physical exercise program called Blooming Exercise Program (BEP) developed during pregnancy in order to control excessive maternal weight gain and its consequences. Additionally, other objectives of the study were to analyse the influence of BEP on urinary incontinence, on the other pregnancy outcomes (maternal and foetal) and on the perception of the pregnant's health.
DESIGN: A randomized, controlled trial called has been conducted. 300 healthy pregnant women were recruited and divided into an intervention group (IG, n=100) and a control group (CG, n=200). The IG participated in BEP as from week 10-12 of gestation (at least 56 sessions through 22 weeks. 3 sessions per week). The CG did not participate in any supervised program addressed to pregnant women but received regular health care. Pregnancy outcomes regarding the mother and the new born, urinary incontinence and women's habits data were obtained and registered through initial interviews, medical records and two specific questionnaires on health and urinary incontinency (ICIQ-SF and King's).
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Madrid
-
Fuenlabrada, Madrid, Spanien, 28942
- Universitarian Hospital of Fuenlabrada
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Healthy pregnant women
- Delivering in "Hospital Universitario de Fuenlabrada"
- At week 10-14 of gestation
- Able to attend 3 sessions per week until the end of the pregnancy
Exclusion Criteria:
- Contraindications appointed by ACOG
- Less than 56 sessions
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Exercise group
Supervised exercise program
|
Intervention group participated in Blooming Exercise Program as from week 10-12 of gestation.
At least 56 sessions through 22 weeks.
3 sessions per week
|
Ingen indgriben: Control
Sedentary pregnant woman
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Maternal weight gain
Tidsramme: week 36-38 of gestation
|
Maternal weight gain and proportion of participants exceeding weight gain above IOM (2009) recommendations
|
week 36-38 of gestation
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Excessive weight gain related risks (gestational diabetes, macrosomia, type of delivery)
Tidsramme: week 36-38 of gestation
|
week 36-38 of gestation
|
Urinary incontinence
Tidsramme: week 36-38 of gestation
|
week 36-38 of gestation
|
Other pregnancy outcomes (maternal and foetal)
Tidsramme: week 36-38 of gestation
|
week 36-38 of gestation
|
Samarbejdspartnere og efterforskere
Efterforskere
- Studieleder: Ruben O Barakat, PhD, Universidad Politécnica de Madrid.
- Ledende efterforsker: Mireia Peláez, PhD, Universidad Politécnica de Madrid.
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 240/09
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