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临床试验/NCT02557893
NCT02557893已完成不适用

Effects of Exercise on Back Pain in Pregnancy

University of Georgia0 个研究点目标入组 134 人开始时间: 2006年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
134
主要终点
Physical function measured with physical tests such as time to make a bed, get up and down off the floor and pick up scarves from the floor.

研究概览

简要总结

Pregnant women at increased risk for back pain were studied during the second trimester and randomized to12-weeks of resistance exercise, education or waitlist. Several outcomes were assessed including physical function, quality of life and mood.

详细描述

A parallel group trial was completed at a single site. Second trimester women (n=134) were randomly assigned (in blocks of 3) to 12-weeks of wait list, bi-monthly pregnancy education classes or twice weekly low-to-moderate intensity resistance training. Resistance training involved one abdominal exercise with no external load and five exercises with an external load that gradually progressed (leg extension, leg press, arm lat pull, leg curl, and lumbar extension). Several outcomes were assessed including physical function, quality of life and mood.

研究设计

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

入排标准

年龄范围
18 Years 至 38 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Pregnant and able to complete baseline testing during gestational week 21 to 25 of pregnancy.

排除标准

  • •Regular resistance exercise training (≥ twice per week during the past month)
  • •an orthopedic or cardiovascular limitation
  • •a psychiatric disorder
  • •or had in the current or a prior pregnancy any of the following:
  • •two or more miscarriages
  • •premature labor
  • •placental previa,
  • •poor fetal growth,
  • •low pre-pregnancy body weight (BMI < 17.5)
  • •a multiple birth pregnancy
  • •pre-eclampsia
  • •preterm rupture of membranes
  • •uterine growth retardation
  • •incompetent cervix/cerclage
  • •recurrent vaginal bleeding
  • •anemia or
  • •diabetes.

研究组 & 干预措施

Resistance exercise

Experimental

Resistance exercise involved 12 weeks of weight lifting exercise

干预措施: Resistance exercise (Behavioral)

Wait list

Sham Comparator

Wait list participants were tested on the outcomes during their pregnancy and were eligible to participate in a post-partum supervised exercise program. The wait list participants formed a no treatment control group.

干预措施: Wait list (Other)

Pregnancy education

Placebo Comparator

Maternity nurses taught six bimonthly pregnancy education classes (~20 per class) which covered several topics including information about what to expect during normal labor and delivery, common interventions during delivery (medications, induction, Cesarean delivery), parenting skills needed for baby care, breastfeeding, baby and child cardiopulmonary resuscitation, typical child development and communicating with infants. No physical activity education was included in the curriculum. The pregnancy education participants formed an attention control group.

干预措施: Education (Other)

结局指标

主要结局

Physical function measured with physical tests such as time to make a bed, get up and down off the floor and pick up scarves from the floor.

时间窗: Change from week 21 to 35 of pregnancy

The intervention occurred from weeks 22 to 34 of pregnancy and the outcomes were measured the week before and after the intervention.

Quality of life measured using the Short Form 36 Healthy Survey.

时间窗: Change from week 21 to 35 of pregnancy

The intervention occurred from weeks 22 to 34 of pregnancy and the outcomes were measured the week before and after the intervention.

Mood measured using the Profile of Mood States questionnaire.

时间窗: Change from week 21 to 35 of pregnancy

The intervention occurred from weeks 22 to 34 of pregnancy and the outcomes were measured the week before and after the intervention.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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