- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03705741
The Efficacy of Light-to-moderate Resistance Training in Sedentary Pregnant Women
The Efficacy of Light-to-moderate Resistance Training in Sedentary Pregnant Women: a Randomized Controlled Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Karlstad, Sweden, 65224
- Fysioterapimottagningen Gripen
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group
|
|
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Experimental: Exercise group
Resistance exercise twice a week
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Resistance exercise twice a week during pregnancy week 23-34.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in fatigue
Time Frame: Register at gestational week 22 and 34
|
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.
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Register at gestational week 22 and 34
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in anxiety / depression
Time Frame: Register at gestational week 22 and 34
|
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
Time Frame: Register at gestational week 22 and 34
|
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
|
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Change in Health Related Quality of Life
Time Frame: Register at gestational week 22 and 34
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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
Time Frame: From perinatal records. Registered at gestational week 22 and 34
|
Systolic and Diastolic
|
From perinatal records. Registered at gestational week 22 and 34
|
|
Change in weight gain
Time Frame: from perinatal records. Registered at gestational week 22 and 34
|
kilogram
|
from perinatal records. Registered at gestational week 22 and 34
|
|
Gestational Diabetes Mellitus (GDM)
Time Frame: from perinatal records. Registered at gestational week 34
|
Development of GDM
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from perinatal records. Registered at gestational week 34
|
|
Change in exercise
Time Frame: Registered at gestational week 22 and 34
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Minutes a day.
(Walks, light, moderate, vigorous intensity).
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Registered at gestational week 22 and 34
|
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Birth weight
Time Frame: from perinatal records at birth (gestational week 40)
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kilogram
|
from perinatal records at birth (gestational week 40)
|
|
Birth length
Time Frame: from perinatal records at birth (gestational week 40)
|
centimeters
|
from perinatal records at birth (gestational week 40)
|
|
Gestational age
Time Frame: From perinatal records at birth (gestational week 40)
|
days
|
From perinatal records at birth (gestational week 40)
|
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Acute cesarean section
Time Frame: from perinatal records at birth (gestational week 40)
|
rate
|
from perinatal records at birth (gestational week 40)
|
|
Macrosomia
Time Frame: from perinatal records at birth (gestational week 40)
|
rate of birth with macrosomia
|
from perinatal records at birth (gestational week 40)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2018/246
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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