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Completed

NCT Number: NCT00476567

Effects of Regular Exercise During Pregnancy

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?

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

standard

Other

standard antenatal care

specific training program

Behavioral

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

Other names: physiotherapy, regular training, specific exercises

Primary outcomes

  1. Gestational diabetes

    Time frame: 20 and 36 weeks pregnancy and 3 months post partum

    insulin resistance

  2. Gestational diabetes

    Time frame: 18 months postpartum

    Insulin resistance

Secondary outcomes

  1. incontinence

    Time frame: 20 and 36 weeks of pregnancy, 3 months post partum

    Fecal- and urinary incontinence (incontinence scores)

  2. lumbopelvic pain

    Time frame: 20 and 36 weeks pregnancy and 3 months post partum

    Lumbopelvic pain (Pain intensity 100mm Visual Analogue Scale)

  3. disability

    Time frame: 20 and 36 weeks pregnancy and 3 months post partum

    Disability Rating Index (Salèn et al. 1994)

  4. incontinence

    Time frame: 18 months postpartum

    Fecal- and urinary incontinence (incontinence scores)

  5. lumbopelvic pain

    Time frame: 18 months postpartum

    Lumbopelvic pain (Pain intensity 100mm Visual Analogue Scale)

  6. disability

    Time frame: 18 months postpartum

    Disability Rating Index (Salèn et al. 1994)

  7. Gestational diabetes

    Time frame: 5 years

    insulin resistance

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • Norwegian Fund for Postgraduate Training in Physiotherapy
  • St. Olavs Hospital

Registry information

Official study title

Training During Pregnancy - Effects of Regular Exercise During Pregnancy in Prevention of Pregnancy-related Diseases and Complications During Labour. A Randomised Clinical Trial

Important dates

Study start
2007
Primary completion
2011
Study completion
2015
First posted
May 22, 2007
Registry last updated
Oct 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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