跳至主要内容
临床试验/NCT03705741
NCT03705741终止不适用

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

Värmland County Council, Sweden2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2018年11月5日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
120
试验地点
2
主要终点
Change in fatigue

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

Opaque sealed envelopes, which are randomly picked out before the meeting with each participant

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Single pregnancy and ≥18 of age
  • Ability to understand verbal and written Swedish
  • Inclusion during gestational week 20+0-20+6.

排除标准

  • 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

结局指标

主要结局

Change in fatigue

时间窗: 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.

次要结局

  • 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))

研究者

发起方
Värmland County Council, Sweden
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Ylva Karolina Petrov Fieril

Principal Investigator, Fysiotherapist, PhD

Värmland County Council, Sweden

研究点 (2)

Loading locations...

相似试验

The Efficacy of Light-to-moderate Resistance... | 临床试验