- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00476567
Effects of Regular Exercise During Pregnancy
Training During Pregnancy - Effects of Regular Exercise During Pregnancy in Prevention of Pregnancy-related Diseases and Complications During Labour. A Randomised Clinical Trial
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?
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Trondheim, Norway, 7489
- Department of Community Medicine and General Practice, Norwegian University of Science and Technology and Clinical Service, St Olavs Hospital, Trondheim University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: exercise
Regular exercise 45-60 minutes minimum three times per week
|
a specific training program 12 weeks between pregnancy week 20 and 36.
regular exercise 45-60 minutes minimum three times per week.
Other Names:
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Active Comparator: control
standard antenatal care
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standard antenatal care
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gestational diabetes
Time Frame: 20 and 36 weeks pregnancy and 3 months post partum
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insulin resistance
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20 and 36 weeks pregnancy and 3 months post partum
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Gestational diabetes
Time Frame: 18 months postpartum
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Insulin resistance
|
18 months postpartum
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
incontinence
Time Frame: 20 and 36 weeks of pregnancy, 3 months post partum
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Fecal- and urinary incontinence (incontinence scores)
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20 and 36 weeks of pregnancy, 3 months post partum
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lumbopelvic pain
Time Frame: 20 and 36 weeks pregnancy and 3 months post partum
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Lumbopelvic pain (Pain intensity 100mm Visual Analogue Scale)
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20 and 36 weeks pregnancy and 3 months post partum
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disability
Time Frame: 20 and 36 weeks pregnancy and 3 months post partum
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Disability Rating Index (Salèn et al. 1994)
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20 and 36 weeks pregnancy and 3 months post partum
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incontinence
Time Frame: 18 months postpartum
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Fecal- and urinary incontinence (incontinence scores)
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18 months postpartum
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lumbopelvic pain
Time Frame: 18 months postpartum
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Lumbopelvic pain (Pain intensity 100mm Visual Analogue Scale)
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18 months postpartum
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disability
Time Frame: 18 months postpartum
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Disability Rating Index (Salèn et al. 1994)
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18 months postpartum
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Gestational diabetes
Time Frame: 5 years
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insulin resistance
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5 years
|
Collaborators and Investigators
Investigators
- Study Chair: Siv Mørkved, PhD, Norwegian University of Science and Technology
Publications and helpful links
General Publications
- Woodley SJ, Lawrenson P, Boyle R, Cody JD, Morkved S, Kernohan A, Hay-Smith EJC. Pelvic floor muscle training for preventing and treating urinary and faecal incontinence in antenatal and postnatal women. Cochrane Database Syst Rev. 2020 May 6;5(5):CD007471. doi: 10.1002/14651858.CD007471.pub4.
- Stokkeland LMT, Giskeodegard GF, Ryssdal M, Jarmund AH, Steinkjer B, Madssen TS, Stafne SN, Stridsklev S, Lovvik TS, Iversen AC, Vanky E. Changes in Serum Cytokines Throughout Pregnancy in Women With Polycystic Ovary Syndrome. J Clin Endocrinol Metab. 2022 Jan 1;107(1):39-52. doi: 10.1210/clinem/dgab684.
- Stafne SN, Salvesen KA, Romundstad PR, Eggebo TM, Carlsen SM, Morkved 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.
- Stafne SN, Salvesen KA, Romundstad PR, Stuge B, Morkved 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 Mar 29.
- Gustafsson MK, Stafne SN, Romundstad PR, Morkved 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. doi: 10.1111/1471-0528.13570. Epub 2015 Aug 12.
- Gustafsson MK, Romundstad PR, Stafne SN, Helvik AS, Stunes AK, Morkved S, Salvesen KA, 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 trial. BMC Pregnancy Childbirth. 2019 Feb 20;19(1):76. doi: 10.1186/s12884-019-2220-z.
- Johannessen HH, Froshaug BE, Lysaker PJG, Salvesen KA, Lukasse M, Morkved S, Stafne SN. Regular antenatal exercise including pelvic floor muscle training reduces urinary incontinence 3 months postpartum-Follow up of a randomized controlled trial. Acta Obstet Gynecol Scand. 2021 Feb;100(2):294-301. doi: 10.1111/aogs.14010. Epub 2020 Oct 30.
- Bjontegaard KA, Stafne SN, Morkved S, Salvesen KA, Evensen KAI. Body mass index and physical activity in seven-year-old children whose mothers exercised during pregnancy: follow-up of a multicentre randomised controlled trial. BMC Pediatr. 2021 Nov 8;21(1):496. doi: 10.1186/s12887-021-02952-1.
- Stafne SN, Vollestad NK, Morkved S, Salvesen KA, Stendal Robinson H. Impact of job adjustment, pain location and exercise on sick leave due to lumbopelvic pain in pregnancy: a longitudinal study. Scand J Prim Health Care. 2019 Jun;37(2):218-226. doi: 10.1080/02813432.2019.1608058. Epub 2019 May 6.
- Hellenes OM, Vik T, Lohaugen GC, Salvesen KA, Stafne SN, Morkved S, Evensen KA. Regular moderate exercise during pregnancy does not have an adverse effect on the neurodevelopment of the child. Acta Paediatr. 2015 Mar;104(3):285-91. doi: 10.1111/apa.12890. Epub 2015 Feb 4.
- Helseth R, Salvesen O, Stafne SN, Morkved S, Salvesen KA, Carlsen SM. Gestational diabetes mellitus among Nordic Caucasian women: prevalence and risk factors according to WHO and simplified IADPSG criteria. Scand J Clin Lab Invest. 2014 Oct;74(7):620-8. doi: 10.3109/00365513.2014.928942. Epub 2014 Jul 1.
- Songoygard KM, Stafne SN, Evensen KAI, Salvesen KA, Vik T, Morkved S. Does exercise during pregnancy prevent postnatal depression? A randomized controlled trial. Acta Obstet Gynecol Scand. 2012 Jan;91(1):62-67. doi: 10.1111/j.1600-0412.2011.01262.x. Epub 2011 Oct 24.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REK4.2007.81
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