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Effects of Regular Exercise During Pregnancy
This study is currently recruiting participants.
Verified by Norwegian University of Science and Technology, March 2008
Sponsors and Collaborators: Norwegian University of Science and Technology
Norwegian Fund for Postgraduate Training in Physiotherapy
St. Olavs Hospital
Information provided by: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00476567
  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
Behavioral: training in pregnancy
Behavioral: Regular training

MedlinePlus related topics: Exercise and Physical Fitness Urinary Incontinence
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
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

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

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

Secondary Outcome Measures:
  • Fecal- and urinary incontinence (incontinence scores) / Lumbopelvic pain: Pain intensity 100mm Visual Analogue Scale, Disability Rating Index (Salèn et al. 1994)/ labour [ Time Frame: 20 and 36 weeks of pregnancy, 3 months post partum ] [ Designated as safety issue: No ]

Estimated Enrollment: 880
Study Start Date: May 2007
Estimated Study Completion Date: May 2020
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Regular exercise 45-60 minutes minimum three times per week
Behavioral: training in pregnancy
Regular exercise 45-60 minutes minimum three times per week
Behavioral: Regular training
Following a specific training program 12 weeks between pregnancy week 20 and 36
2: No Intervention
standard care

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 musculo-skeletal problems such as low back and pelvic girdle pain and urinary and fecal incontinence. While pregnancy and labor implies 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 thus 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 are highlighted. WHO has recently presented a global strategy for nutrition, physical activity and health (Sosial- og helsedepartementet, 2004). 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 women who attend the routine ultrasound control at the three hospitals at 18 weeks of pregnancy are invited to participate in the study. Women are eligible for the trial if they are healthy, 18 years or more, with a singleton live foetus at the routine ultrasound scan and a normal pregnancy.

Exclusion Criteria:

  • Exclusion criteria are pregnancy complications, high risk for preterm labour, pain during pelvic floor muscle contractions, ongoing urinary tract infection, or diseases that could interfere with participation (following recommendations from SEF 2000, ACOG 2003). In addition, women who live too far from the hospitals to be able to attend weekly exercise groups will be excluded.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00476567

Contacts
Contact: Siv Mørkved, PhD +4773597584 siv.morkved@ntnu.no
Contact: Signe Nilsen Stafne, MSc

Locations
Norway
Department of Community Medicine and General Practice, Norwegian University of Science and Technology and Clinical Service, St Olavs Hospital, Trondheim University Hospital Recruiting
Trondheim, Norway, 7489
Contact: Siv Mørkved, PhD     +4773597584     siv.morkved@ntnu.no    
Contact: Kjell Åsmund Salvesen, professor            
Principal Investigator: Siv Mørkved Mørkved, PhD            
Principal Investigator: Kjell Åsmund Salvesen, professor            
Sub-Investigator: Signe Nilsen Stafne, MSc            
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

Responsible Party: Norwegian University of Science and Technology ( Associate professor Siv Mørkved )
Study ID Numbers: REK4.2007.81
Study First Received: May 21, 2007
Last Updated: March 31, 2008
ClinicalTrials.gov Identifier: NCT00476567  
Health Authority: Norway: Norwegian Social Science Data Services

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

Study placed in the following topic categories:
Pregnancy Complications

ClinicalTrials.gov processed this record on January 16, 2009