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

Pregnancy Related Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03705741
• Other study ID #: 2018/246
• Status: Recruiting
• Phase: N/A
• Start date: November 5, 2018
• Est. completion date: July 1, 2025

Study information

• Verified date: September 2023
• Source: Värmland County Council, Sweden
• Contact: Karolina Petrov Fieril, PhD
• Phone: +46730720265
• Email: fieril[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy Related
• Sedentary Lifestyle

Intervention

Behavioral:
• Resistance exercise
Resistance exercise twice a week during pregnancy week 23-34.

Locations

Country	Name	City	State
Sweden	Fysioterapimottagningen Gripen	Karlstad

Sponsors (1)

Lead Sponsor	Collaborator
Värmland County Council, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Change in blood pressure	Systolic and Diastolic	From perinatal records. Registered at gestational week 22 and 34
Secondary	Change in weight gain	kilogram	from perinatal records. Registered at gestational week 22 and 34
Secondary	Gestational Diabetes Mellitus (GDM)	Development of GDM	from perinatal records. Registered at gestational week 34
Secondary	Change in exercise	Minutes a day. (Walks, light, moderate, vigorous intensity).	Registered at gestational week 22 and 34
Secondary	Birth weight	kilogram	from perinatal records at birth (gestational week 40)
Secondary	Birth length	centimeters	from perinatal records at birth (gestational week 40)
Secondary	Gestational age	days	From perinatal records at birth (gestational week 40)
Secondary	Acute cesarean section	rate	from perinatal records at birth (gestational week 40)
Secondary	Macrosomia	rate of birth with macrosomia	from perinatal records at birth (gestational week 40)