Effects of Regular Exercise During Pregnancy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pregnancy Complications

Intervention / Treatment
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* Other: standard
* Behavioral: specific training program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: exercise<br>Regular exercise 45-60 minutes minimum three times per week | Behavioral: specific training program<br>* a specific training program 12 weeks between pregnancy week 20 and 36. regular exercise 45-60 minutes minimum three times per week.<br>* Other names: specific exercises;|
| Active Comparator: control<br>standard antenatal care | Other: standard<br>* standard antenatal care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational diabetes | insulin resistance | 20 and 36 weeks pregnancy and 3 months post partum | 
| Gestational diabetes | Insulin resistance | 18 months postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incontinence | Fecal- and urinary incontinence (incontinence scores) | 20 and 36 weeks of pregnancy, 3 months post partum | 
| lumbopelvic pain | Lumbopelvic pain (Pain intensity 100mm Visual Analogue Scale) | 20 and 36 weeks pregnancy and 3 months post partum | 
| disability | Disability Rating Index (Salèn et al. 1994) | 20 and 36 weeks pregnancy and 3 months post partum | 
| incontinence | Fecal- and urinary incontinence (incontinence scores) | 18 months postpartum | 
| lumbopelvic pain | Lumbopelvic pain (Pain intensity 100mm Visual Analogue Scale) | 18 months postpartum | 
| disability | Disability Rating Index (Salèn et al. 1994) | 18 months postpartum | 
| Gestational diabetes | insulin resistance | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise, pregnancy, prevention, pregnancy-related diseases, labor, complications, physiotherapy