The Efficacy of Light-to-moderate Resistance Training in Sedentary Pregnant Women

Study Overview
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Brief Summary
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Maintaining a physically active lifestyle is associated with many health benefits, including lower risk of cardiovascular disease, diabetes, hypertension, some type of cancer, and depression . Pregnant, healthy women are recommended to do 30 minutes or more of light to moderate exercise a day, although most women in the Western world do not follow current recommendations and decrease their exercise level. Benefits of exercise during pregnancy are several, including a protective effect against the development of gestational diabetes mellitus, reduced pregnancy related low back pain, and risk of caesarean delivery. On the contrary, a recent review concludes that sedentary behaviors are associated with higher levels of C Reactive Protein and LDL Cholesterol, a larger newborn abdominal circumference, and macrosomia. Previous studies show that exercise during pregnancy is associated with improvements in psychological well-being among previously sedentary women. Only a few RCT's have studied resistance exercise during pregnancy. These studies have found reduced fatigue and reduced need of insulin among women with gestational diabetes mellitus who did resistance exercise, with no adverse effects on fetus or the pregnant woman. The aim of this study is to evaluate the efficacy of regular light -to-moderate resistance exercise among sedentary pregnant woman, with regard to fatigue, health related quality of life, pain location and intensity, body weight gain, blood pressure, and childbirth outcomes.

Official Title
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The Efficacy of Light-to-moderate Resistance Training in Sedentary Pregnant Women: a Randomized Controlled Study

Conditions
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Pregnancy Related, Sedentary Lifestyle

Intervention / Treatment
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* Behavioral: Resistance exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Single pregnancy and ≥18 of age Ability to understand verbal and written Swedish Inclusion during gestational week 20+0-20+6. Exclusion Criteria: Follows the recommendation regarding contraindications according to the American Collage of Obstetricians and Gynecologists 2002 Severe pain from the pelvic or the back Regular exercise >150 minutes per week the last six months

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 group<br>Resistance exercise twice a week | Behavioral: Resistance exercise<br>* Resistance exercise twice a week during pregnancy week 23-34.<br>|
| No Intervention: Control group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fatigue | Visual Analogue Scale (VAS) 0-100 millimeters. It is a psychometric scale and measure self-reported fatigue from 0, no fatigue to 100, very great fatigue. The scale is a streight horizontal line. | Register at gestational week 22 and 34 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in anxiety / depression | Visual Analogue Scale (VAS) 0-100 millimeters. It is a psychometric scale and measure self-reported anxiety/depression from 0, no anxiety/depression to 100, very great anxiety/depression. The scale is a streight horizontal line. | Register at gestational week 22 and 34 | 
| Change in pain | Visual Analogue Scale (VAS) 0-100 millimeters. It is a psychometric scale and measure the intensity of pain from 0, none pain to 100, extreme amount of pain. The scale is a streight horizontal line. | Register at gestational week 22 and 34 | 
| Change in Health Related Quality of Life | Visual Analogue Scale (EQ-VAS). Mark health status on the day on a 20 centimeters vertical scale with end points of 0 and 100. There are notes at the both ends of the scale that the bottom rate (0) corresponds to  the worst health you can imagine, and the highest rate (100) corresponds to the best health you can imagine. | Register at gestational week 22 and 34 | 
| Change in blood pressure | Systolic and Diastolic | From perinatal records. Registered at gestational week 22 and 34 | 
| Change in weight gain | kilogram | from perinatal records. Registered at gestational week 22 and 34 | 
| Gestational Diabetes Mellitus (GDM) | Development of GDM | from perinatal records. Registered at gestational week 34 | 
| Change in exercise | Minutes a day. (Walks, light, moderate, vigorous intensity). | Registered at gestational week 22 and 34 | 
| Birth weight | kilogram | from perinatal records at birth (gestational week 40) | 
| Birth length | centimeters | from perinatal records at birth (gestational week 40) | 
| Gestational age | days | From perinatal records at birth (gestational week 40) | 
| Acute cesarean section | rate | from perinatal records at birth (gestational week 40) | 
| Macrosomia | rate of birth with macrosomia | from perinatal records at birth (gestational week 40) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pregnancy, exercise, public health, randomized controlled trial