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Sponsors and Collaborators: |
Norwegian University of Science and Technology Norwegian Fund for Postgraduate Training in Physiotherapy St. Olavs Hospital |
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Information provided by: | Norwegian University of Science and Technology |
ClinicalTrials.gov Identifier: | NCT00476567 |
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:
Condition | Intervention |
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Pregnancy Complications |
Behavioral: training in pregnancy Behavioral: Regular training |
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 |
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 |
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1: Experimental
Regular exercise 45-60 minutes minimum three times per week
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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
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2: No Intervention
standard care
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Siv Mørkved, PhD | +4773597584 | siv.morkved@ntnu.no |
Contact: Signe Nilsen Stafne, MSc |
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 |
Study Chair: | Siv Mørkved, PhD | Norwegian University of Science and Technology |
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 |
exercise pregnancy prevention pregnancy-related diseases |
labor complications physiotherapy |
Pregnancy Complications |