ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Regular Exercise During Pregnancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00476567
Recruitment Status : Completed
First Posted : May 22, 2007
Last Update Posted : August 19, 2015
Sponsor:
Collaborators:
Norwegian Fund for Postgraduate Training in Physiotherapy
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology

May 21, 2007
May 22, 2007
August 19, 2015
May 2007
June 2011   (Final data collection date for primary outcome measure)
  • Gestational diabetes [ Time Frame: 20 and 36 weeks pregnancy and 3 months post partum ]
    insulin resistance
  • Gestational diabetes [ Time Frame: 18 months postpartum ]
    Insulin resistance
All assessments at 20 and 36 weeks pregnancy and 3 months post partum: - Gestational diabetes: Oral glucose tolerance test - Low back and pelvic girdle pain: Pain intensity 100mm Visual Analogue Scale, Disability Rating Index (Salèn et al. 1994)
Complete list of historical versions of study NCT00476567 on ClinicalTrials.gov Archive Site
  • incontinence [ Time Frame: 20 and 36 weeks of pregnancy, 3 months post partum ]
    Fecal- and urinary incontinence (incontinence scores)
  • lumbopelvic pain [ Time Frame: 20 and 36 weeks pregnancy and 3 months post partum ]
    Lumbopelvic pain (Pain intensity 100mm Visual Analogue Scale)
  • disability [ Time Frame: 20 and 36 weeks pregnancy and 3 months post partum ]
    Disability Rating Index (Salèn et al. 1994)
  • incontinence [ Time Frame: 18 months postpartum ]
    Fecal- and urinary incontinence (incontinence scores)
  • lumbopelvic pain [ Time Frame: 18 months postpartum ]
    Lumbopelvic pain (Pain intensity 100mm Visual Analogue Scale)
  • disability [ Time Frame: 18 months postpartum ]
    Disability Rating Index (Salèn et al. 1994)
  • Gestational diabetes [ Time Frame: 5 years ]
    insulin resistance
Not Provided
Not Provided
Not Provided
 
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?

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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Pregnancy Complications
  • Other: standard
    standard antenatal care
  • Behavioral: specific training program
    a specific training program 12 weeks between pregnancy week 20 and 36. regular exercise 45-60 minutes minimum three times per week.
    Other Names:
    • physiotherapy
    • regular training
    • specific exercises
  • Experimental: exercise
    Regular exercise 45-60 minutes minimum three times per week
    Intervention: Behavioral: specific training program
  • Active Comparator: control
    standard antenatal care
    Intervention: Other: standard

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
855
880
June 2015
June 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Norway
 
 
NCT00476567
REK4.2007.81
No
Not Provided
Not Provided
Norwegian University of Science and Technology
Norwegian University of Science and Technology
  • Norwegian Fund for Postgraduate Training in Physiotherapy
  • St. Olavs Hospital
Study Chair: Siv Mørkved, PhD Norwegian University of Science and Technology
Norwegian University of Science and Technology
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP