Effects of Regular Exercise During Pregnancy

NCT ID: NCT00476567

Last Updated: 2020-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

855 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2015-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pregnancy Complications

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

exercise

Regular exercise 45-60 minutes minimum three times per week

Group Type EXPERIMENTAL

specific training program

Intervention Type BEHAVIORAL

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

control

standard antenatal care

Group Type ACTIVE_COMPARATOR

standard

Intervention Type OTHER

standard antenatal care

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

standard

standard antenatal care

Intervention Type OTHER

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.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

physiotherapy regular training specific exercises

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Norwegian Fund for Postgraduate Training in Physiotherapy

OTHER

Sponsor Role collaborator

St. Olavs Hospital

OTHER

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Siv Mørkved, PhD

Role: STUDY_CHAIR

Norwegian University of Science and Technology

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Trondheim, , Norway

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Norway

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 22183208 (View on PubMed)

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.

Reference Type RESULT
PMID: 22364387 (View on PubMed)

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.

Reference Type RESULT
PMID: 26265465 (View on PubMed)

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.

Reference Type RESULT
PMID: 30786861 (View on PubMed)

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.

Reference Type RESULT
PMID: 32996139 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38269252 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34743682 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34529073 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32378735 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31057021 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25471255 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24980704 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21880023 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

REK4.2007.81

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Pregnancy 24/7 Cohort Study
NCT04749849 COMPLETED