NCT00476567

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
855

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

May 21, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 22, 2007

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

October 5, 2020

Status Verified

October 1, 2020

Enrollment Period

4.1 years

First QC Date

May 21, 2007

Last Update Submit

October 1, 2020

Conditions

Pregnancy Complications

Keywords

exercisepregnancypreventionpregnancy-related diseaseslaborcomplicationsphysiotherapy

Outcome Measures

Primary Outcomes (2)

  • Gestational diabetes

    insulin resistance

    20 and 36 weeks pregnancy and 3 months post partum

  • Gestational diabetes

    Insulin resistance

    18 months postpartum

Secondary Outcomes (7)

  • incontinence

    20 and 36 weeks of pregnancy, 3 months post partum

  • lumbopelvic pain

    20 and 36 weeks pregnancy and 3 months post partum

  • disability

    20 and 36 weeks pregnancy and 3 months post partum

  • incontinence

    18 months postpartum

  • lumbopelvic pain

    18 months postpartum

  • +2 more secondary outcomes

Study Arms (2)

exercise

EXPERIMENTAL

Regular exercise 45-60 minutes minimum three times per week

Behavioral: specific training program

control

ACTIVE COMPARATOR

standard antenatal care

Other: standard

Interventions

standardOTHER

standard antenatal care

control
specific training programBEHAVIORAL

a specific training program 12 weeks between pregnancy week 20 and 36. regular exercise 45-60 minutes minimum three times per week.

Also known as: physiotherapy, regular training, specific exercises
exercise

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Community Medicine and General Practice, Norwegian University of Science and Technology and Clinical Service, St Olavs Hospital, Trondheim University Hospital

Trondheim, 7489, Norway

Location

Related Publications (13)

  • 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.

    PMID: 22183208RESULT

  • 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.

    PMID: 22364387RESULT

  • 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.

    PMID: 26265465RESULT

  • 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.

    PMID: 30786861RESULT

  • 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.

    PMID: 32996139RESULT

  • Nyen SL, Stunes AK, Evensen KAI, Borsting T, Syversen U, Salvesen KA, Morkved S, Stafne SN. Associations between maternal and offspring glucose metabolism: a 9-year follow-up of a randomised controlled trial. Front Endocrinol (Lausanne). 2024 Jan 10;14:1324925. doi: 10.3389/fendo.2023.1324925. eCollection 2023.

    PMID: 38269252DERIVED

  • 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.

    PMID: 34743682DERIVED

  • 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.

    PMID: 34529073DERIVED

  • 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.

    PMID: 32378735DERIVED

  • 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.

    PMID: 31057021DERIVED

  • 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.

    PMID: 25471255DERIVED

  • 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.

    PMID: 24980704DERIVED

  • 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.

    PMID: 21880023DERIVED

MeSH Terms

Conditions

Pregnancy ComplicationsMotor Activity

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesBehavior

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Siv Mørkved, PhD

    Norwegian University of Science and Technology

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2007

First Posted

May 22, 2007

Study Start

May 1, 2007

Primary Completion

June 1, 2011

Study Completion

June 1, 2015

Last Updated

October 5, 2020

Record last verified: 2020-10

Locations

NO(1)