Clinical trial NCT03705741: The Efficacy of Light-to-moderate Resistance Training in Sedentary Pregnant Women
Official title: The Efficacy of Light-to-moderate Resistance Training in Sedentary Pregnant Women: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pregnancy Related
Sedentary Lifestyle
Keywords: pregnancy
exercise
public health
randomized controlled trial
Lead sponsor: Värmland County Council, Sweden
Sponsor class: OTHER_GOV
First posted: 2018-10-15
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Change in fatigue
timeFrame: Register at gestational week 22 and 34
Secondary outcomes:
measure: Change in anxiety / depression
timeFrame: Register at gestational week 22 and 34
measure: Change in pain
timeFrame: Register at gestational week 22 and 34
measure: Change in Health Related Quality of Life
timeFrame: Register at gestational week 22 and 34
measure: Change in blood pressure
timeFrame: From perinatal records. Registered at gestational week 22 and 34
measure: Change in weight gain
timeFrame: from perinatal records. Registered at gestational week 22 and 34
measure: Gestational Diabetes Mellitus (GDM)
timeFrame: from perinatal records. Registered at gestational week 34
measure: Change in exercise
timeFrame: Registered at gestational week 22 and 34
measure: Birth weight
timeFrame: from perinatal records at birth (gestational week 40)
measure: Birth length
timeFrame: from perinatal records at birth (gestational week 40)
measure: Gestational age
timeFrame: From perinatal records at birth (gestational week 40)
measure: Acute cesarean section
timeFrame: from perinatal records at birth (gestational week 40)
measure: Macrosomia
timeFrame: from perinatal records at birth (gestational week 40)
Other outcomes:
Locations:
city: Karlstad
country: Sweden
facility: Fysioterapimottagningen Gripen
Study officials:
References: