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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 : February 26, 2019
Sponsor:
Collaborators:
Norwegian Fund for Postgraduate Training in Physiotherapy
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Tracking Information
First Submitted Date  ICMJE May 21, 2007
First Posted Date  ICMJE May 22, 2007
Last Update Posted Date February 26, 2019
Study Start Date  ICMJE May 2007
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2012)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: May 21, 2007)
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)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2015)
  • 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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Regular Exercise During Pregnancy
Official Title  ICMJE Training During Pregnancy - Effects of Regular Exercise During Pregnancy in Prevention of Pregnancy-related Diseases and Complications During Labour. A Randomised Clinical Trial
Brief Summary

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?
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Pregnancy Complications
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 23, 2011)
855
Original Estimated Enrollment  ICMJE
 (submitted: May 21, 2007)
880
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00476567
Other Study ID Numbers  ICMJE REK4.2007.81
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Norwegian University of Science and Technology
Study Sponsor  ICMJE Norwegian University of Science and Technology
Collaborators  ICMJE
  • Norwegian Fund for Postgraduate Training in Physiotherapy
  • St. Olavs Hospital
Investigators  ICMJE
Study Chair: Siv Mørkved, PhD Norwegian University of Science and Technology
PRS Account Norwegian University of Science and Technology
Verification Date February 2019

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