Effects of Regular Exercise During Pregnancy

Pregnancy Complications Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00476567
• Other study ID #: REK4.2007.81
• Status: Completed
• Phase: N/A
• Start date: May 2007
• Est. completion date: June 2015

Study information

• Verified date: October 2020
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 855
• Est. completion date: June 2015
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy Complications

Intervention

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.

Locations

Country	Name	City	State
Norway	Department of Community Medicine and General Practice, Norwegian University of Science and Technology and Clinical Service, St Olavs Hospital, Trondheim University Hospital	Trondheim

Sponsors (3)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Norwegian Fund for Postgraduate Training in Physiotherapy, St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (5)

Gustafsson MK, Romundstad PR, Stafne SN, Helvik AS, Stunes AK, Mørkved S, Salvesen KÅ, Thorsby PM, Mosti MP, Syversen U. The effect of an exercise program in pregnancy on vitamin D status among healthy, pregnant Norwegian women: a randomized controlled tr — View Citation

Gustafsson MK, Stafne SN, Romundstad PR, Mørkved S, Salvesen K, Helvik AS. The effects of an exercise programme during pregnancy on health-related quality of life in pregnant women: a Norwegian randomised controlled trial. BJOG. 2016 Jun;123(7):1152-60. d — View Citation

Johannessen HH, Frøshaug BE, Lysåker PJG, Salvesen KÅ, Lukasse M, Mørkved S, Stafne SN. Regular antenatal exercise including pelvic floor muscle training reduces urinary incontinence three months postpartum - Follow-up of a randomised controlled trial. Ac — View Citation

Stafne SN, Salvesen KÅ, Romundstad PR, Eggebø TM, Carlsen SM, Mørkved S. Regular exercise during pregnancy to prevent gestational diabetes: a randomized controlled trial. Obstet Gynecol. 2012 Jan;119(1):29-36. doi: 10.1097/AOG.0b013e3182393f86. — View Citation

Stafne SN, Salvesen KÅ, Romundstad PR, Stuge B, Mørkved S. Does regular exercise during pregnancy influence lumbopelvic pain? A randomized controlled trial. Acta Obstet Gynecol Scand. 2012 May;91(5):552-9. doi: 10.1111/j.1600-0412.2012.01382.x. Epub 2012 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gestational diabetes	insulin resistance	20 and 36 weeks pregnancy and 3 months post partum
Primary	Gestational diabetes	Insulin resistance	18 months postpartum
Secondary	incontinence	Fecal- and urinary incontinence (incontinence scores)	20 and 36 weeks of pregnancy, 3 months post partum
Secondary	lumbopelvic pain	Lumbopelvic pain (Pain intensity 100mm Visual Analogue Scale)	20 and 36 weeks pregnancy and 3 months post partum
Secondary	disability	Disability Rating Index (Salèn et al. 1994)	20 and 36 weeks pregnancy and 3 months post partum
Secondary	incontinence	Fecal- and urinary incontinence (incontinence scores)	18 months postpartum
Secondary	lumbopelvic pain	Lumbopelvic pain (Pain intensity 100mm Visual Analogue Scale)	18 months postpartum
Secondary	disability	Disability Rating Index (Salèn et al. 1994)	18 months postpartum
Secondary	Gestational diabetes	insulin resistance	5 years