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Effects of Regular Exercise During Pregnancy

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Norwegian Fund for Postgraduate Training in Physiotherapy
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00476567
First received: May 21, 2007
Last updated: June 15, 2012
Last verified: June 2012
History of Changes
  Purpose

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?

Condition Intervention
Pregnancy Complications
 Other: standard
Behavioral: specific training program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Training During Pregnancy - Effects of Regular Exercise During Pregnancy in Prevention of Pregnancy-related Diseases and Complications During Labour. A Randomised Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Gestational diabetes [ Time Frame: 20 and 36 weeks pregnancy and 3 months post partum ] [ Designated as safety issue: No ]
    insulin resistance

  • Gestational diabetes [ Time Frame: 18 months postpartum ] [ Designated as safety issue: No ]
    Insulin resistance


Secondary Outcome Measures:
  • incontinence [ Time Frame: 20 and 36 weeks of pregnancy, 3 months post partum ] [ Designated as safety issue: No ]
    Fecal- and urinary incontinence (incontinence scores)

  • lumbopelvic pain [ Time Frame: 20 and 36 weeks pregnancy and 3 months post partum ] [ Designated as safety issue: No ]
    Lumbopelvic pain (Pain intensity 100mm Visual Analogue Scale)

  • disability [ Time Frame: 20 and 36 weeks pregnancy and 3 months post partum ] [ Designated as safety issue: No ]
    Disability Rating Index (Salèn et al. 1994)

  • incontinence [ Time Frame: 18 months postpartum ] [ Designated as safety issue: No ]
    Fecal- and urinary incontinence (incontinence scores)

  • lumbopelvic pain [ Time Frame: 18 months postpartum ] [ Designated as safety issue: No ]
    Lumbopelvic pain (Pain intensity 100mm Visual Analogue Scale)

  • disability [ Time Frame: 18 months postpartum ] [ Designated as safety issue: No ]
    Disability Rating Index (Salèn et al. 1994)


Enrollment: 855
Study Start Date: May 2007
Estimated Study Completion Date: June 2017
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: exercise
Regular exercise 45-60 minutes minimum three times per week
 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
No Intervention: control
standard antenatal care
 Other: standard
standard antenatal care
Other Names:
  • physiotherapy
  • training in pregnancy

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00476567

Locations
Norway
Department of Community Medicine and General Practice, Norwegian University of Science and Technology and Clinical Service, St Olavs Hospital, Trondheim University Hospital
Trondheim, Norway, 7489
Sponsors and Collaborators
Norwegian University of Science and Technology
Norwegian Fund for Postgraduate Training in Physiotherapy
St. Olavs Hospital
Investigators
Study Chair: Siv Mørkved, PhD Norwegian University of Science and Technology
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00476567     History of Changes
Other Study ID Numbers: REK4.2007.81
Study First Received: May 21, 2007
Last Updated: June 15, 2012
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Norwegian University of Science and Technology:
exercise
pregnancy
prevention
pregnancy-related diseases
 labor
complications
physiotherapy

Additional relevant MeSH terms:
Pregnancy Complications

ClinicalTrials.gov processed this record on May 16, 2013