Effects of Regular Exercise During Pregnancy
Primary Purpose
Pregnancy Complications
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
standard
specific training program
Sponsored by
About this trial
This is an interventional prevention trial for Pregnancy Complications focused on measuring exercise, pregnancy, prevention, pregnancy-related diseases, labor, complications, physiotherapy
Eligibility 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
Sites / Locations
- Department of Community Medicine and General Practice, Norwegian University of Science and Technology and Clinical Service, St Olavs Hospital, Trondheim University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
exercise
control
Arm Description
Regular exercise 45-60 minutes minimum three times per week
standard antenatal care
Outcomes
Primary Outcome Measures
Gestational diabetes
insulin resistance
Gestational diabetes
Insulin resistance
Secondary Outcome Measures
incontinence
Fecal- and urinary incontinence (incontinence scores)
lumbopelvic pain
Lumbopelvic pain (Pain intensity 100mm Visual Analogue Scale)
disability
Disability Rating Index (Salèn et al. 1994)
incontinence
Fecal- and urinary incontinence (incontinence scores)
lumbopelvic pain
Lumbopelvic pain (Pain intensity 100mm Visual Analogue Scale)
disability
Disability Rating Index (Salèn et al. 1994)
Gestational diabetes
insulin resistance
Full Information
NCT ID
NCT00476567
First Posted
May 21, 2007
Last Updated
October 1, 2020
Sponsor
Norwegian University of Science and Technology
Collaborators
Norwegian Fund for Postgraduate Training in Physiotherapy, St. Olavs Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00476567
Brief Title
Effects of Regular Exercise During Pregnancy
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
Norwegian Fund for Postgraduate Training in Physiotherapy, St. Olavs Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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?
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Complications
Keywords
exercise, pregnancy, prevention, pregnancy-related diseases, labor, complications, physiotherapy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
855 (Actual)
8. Arms, Groups, and Interventions
Arm Title
exercise
Arm Type
Experimental
Arm Description
Regular exercise 45-60 minutes minimum three times per week
Arm Title
control
Arm Type
Active Comparator
Arm Description
standard antenatal care
Intervention Type
Other
Intervention Name(s)
standard
Intervention Description
standard antenatal care
Intervention Type
Behavioral
Intervention Name(s)
specific training program
Other Intervention Name(s)
physiotherapy, regular training, specific exercises
Intervention Description
a specific training program 12 weeks between pregnancy week 20 and 36. regular exercise 45-60 minutes minimum three times per week.
Primary Outcome Measure Information:
Title
Gestational diabetes
Description
insulin resistance
Time Frame
20 and 36 weeks pregnancy and 3 months post partum
Title
Gestational diabetes
Description
Insulin resistance
Time Frame
18 months postpartum
Secondary Outcome Measure Information:
Title
incontinence
Description
Fecal- and urinary incontinence (incontinence scores)
Time Frame
20 and 36 weeks of pregnancy, 3 months post partum
Title
lumbopelvic pain
Description
Lumbopelvic pain (Pain intensity 100mm Visual Analogue Scale)
Time Frame
20 and 36 weeks pregnancy and 3 months post partum
Title
disability
Description
Disability Rating Index (Salèn et al. 1994)
Time Frame
20 and 36 weeks pregnancy and 3 months post partum
Title
incontinence
Description
Fecal- and urinary incontinence (incontinence scores)
Time Frame
18 months postpartum
Title
lumbopelvic pain
Description
Lumbopelvic pain (Pain intensity 100mm Visual Analogue Scale)
Time Frame
18 months postpartum
Title
disability
Description
Disability Rating Index (Salèn et al. 1994)
Time Frame
18 months postpartum
Title
Gestational diabetes
Description
insulin resistance
Time Frame
5 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Siv Mørkved, PhD
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Community Medicine and General Practice, Norwegian University of Science and Technology and Clinical Service, St Olavs Hospital, Trondheim University Hospital
City
Trondheim
ZIP/Postal Code
7489
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
22183208
Citation
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.
Results Reference
result
PubMed Identifier
22364387
Citation
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.
Results Reference
result
PubMed Identifier
26265465
Citation
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.
Results Reference
result
PubMed Identifier
30786861
Citation
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.
Results Reference
result
PubMed Identifier
32996139
Citation
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.
Results Reference
result
PubMed Identifier
34743682
Citation
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.
Results Reference
derived
PubMed Identifier
34529073
Citation
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.
Results Reference
derived
PubMed Identifier
32378735
Citation
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.
Results Reference
derived
PubMed Identifier
31057021
Citation
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.
Results Reference
derived
PubMed Identifier
25471255
Citation
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.
Results Reference
derived
PubMed Identifier
24980704
Citation
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.
Results Reference
derived
PubMed Identifier
21880023
Citation
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.
Results Reference
derived
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Effects of Regular Exercise During Pregnancy
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