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Clinical Trials/NCT03705741
NCT03705741
Terminated
Not Applicable

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

Värmland County Council, Sweden1 site in 1 country120 target enrollmentNovember 5, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pregnancy Related
Sponsor
Värmland County Council, Sweden
Enrollment
120
Locations
1
Primary Endpoint
Change in fatigue
Status
Terminated
Last Updated
last year

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
November 5, 2018
End Date
April 15, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Värmland County Council, Sweden
Responsible Party
Principal Investigator
Principal Investigator

Ylva Karolina Petrov Fieril

Principal Investigator, Fysiotherapist, PhD

Värmland County Council, Sweden

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Change in anxiety / depression(Register at gestational week 22 and 34)
  • Change in pain(Register at gestational week 22 and 34)
  • Change in weight gain(from perinatal records. Registered at gestational week 22 and 34)
  • Change in Health Related Quality of Life(Register at gestational week 22 and 34)
  • Change in blood pressure(From perinatal records. Registered at gestational week 22 and 34)
  • Gestational age(From perinatal records at birth (gestational week 40))
  • Birth length(from perinatal records at birth (gestational week 40))
  • Change in exercise(Registered at gestational week 22 and 34)
  • Gestational Diabetes Mellitus (GDM)(from perinatal records. Registered at gestational week 34)
  • Birth weight(from perinatal records at birth (gestational week 40))
  • Acute cesarean section(from perinatal records at birth (gestational week 40))
  • Macrosomia(from perinatal records at birth (gestational week 40))

Study Sites (1)

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