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临床试验/NCT05879575
NCT05879575招募中不适用

Effects and Pathophysiology of Weight Training on Pregnancy-related Pelvic Girdle Pain (PPGP)

National Taiwan University Hospital Hsin-Chu Branch1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2023年5月31日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
70
试验地点
1
主要终点
PGQ score

研究概览

简要总结

In recent years, due to the popularity of exercise during pregnancy, the American College of Obstetricians and Gynecologists recommends that pregnant women should engage in 150 minutes of moderate-intensity exercise per week, including aerobic exercise or weight training. This can help reduce pregnancy complications (such as preeclampsia, gestational diabetes, pelvic pain, etc.) and does not increase the risk of miscarriage or premature birth. Pelvic pain during pregnancy is the most troublesome problem for pregnant women, often affecting their daily lives and mental health, leading to the need for long-term use of painkillers and even affecting their daily routine and sleep. Currently, research has also found that exercise during pregnancy can improve pelvic pain during pregnancy and reduce the inconvenience caused by pain in daily life. However, weight training can strengthen spinal stability and reduce lower back pain problems in non-pregnant individuals, but there is currently no research discussing whether weight training for pregnant women can improve pelvic pain during pregnancy, possibly because weight training for pregnant women is not widely accepted by society and is often associated with misconceptions and prejudices. Recent literature synthesis analysis tells us that weight training during pregnancy does not increase the risk of premature birth or miscarriage. Pregnant women in supervised moderate-intensity weight training do not endanger the health of the mother or fetus, and the safety is sufficient. Therefore, we hope to understand the effects and mechanisms of weight training during pregnancy on pelvic pain during pregnancy through this study.

详细描述

Pregnancy-related pelvic girdle pain is one of the most troubling issues for pregnant women. Everyday activities, such as walking, standing, sitting, and even lying down, can potentially trigger or exacerbate the pain. The diagnostic criteria for pelvic girdle pain are relatively complex. Since the 2008 European guidelines suggested clinical physiotherapy test conditions, they have gradually been adapted for pregnant women. In 2021, Monika revised the diagnostic criteria, allowing pregnant women to self-check for pelvic girdle pain diagnosis, with the following self-test conditions:

Pregnant women have experienced at least one day in the past four weeks when pelvic girdle pain has affected their daily lives.

They can clearly point out the painful area (e.g., sacroiliac joint or pubic symphysis joint pain).

At least one positive anterior pelvic girdle pain test item, or two positive posterior pelvic girdle pain test items, are confirmed through a "pelvic girdle pain self-check." Research has found that 50-70% of pregnant women experience pelvic girdle pain during pregnancy, with 33%-50% experiencing pain even before 20 weeks of gestation. However, 7% continue to have pelvic girdle pain issues for life after childbirth. Pregnancy-related pelvic girdle pain affects daily life and mental health, often leading to long-term use of painkillers and affecting daily routines and sleep.

Recent research suggests that weight training can strengthen spinal stability and reduce lower back pain in non-pregnant individuals. The American College of Obstetricians and Gynecologists recommends pregnant women engage in 150 minutes of moderate-intensity exercise per week, including aerobic exercise or weight training. Studies also show that exercising during pregnancy can improve pelvic girdle pain, reducing inconvenience in daily life, but it cannot reduce the incidence of pain.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women who are within 14 weeks of gestation and carrying a single fetus.
  • Pregnant women who can clearly identify the location of their pelvic girdle pain (e.g. sacroiliac joint or pubic symphysis pain).
  • Pregnant women who have at least one positive result in a front pelvic girdle pain test or two positive results in a back pelvic girdle pain test based on the "Self-Administered Pelvic Girdle Pain Test".
  • Pregnant women assigned to the intervention group must be able to comply with the exercise program.
  • Pregnant women assigned to the control group must not engage in weight training.
  • Definition of weight training: The use of resistance to induce muscular contraction, with the goal of increasing strength and endurance of the muscles. This can be achieved systematically using weights, such as one's own body weight, or equipment that provides resistance to muscle contraction, such as dumbbells, barbells, or resistance bands.
  • Participants will receive follow-up care and delivery at National Taiwan University Hospital in Hsinchu.

排除标准

  • For pregnant women with twins or multiple pregnancies
  • With any pregnancy exercise contraindications from the American College of Obstetricians and Gynecologists, including:
  • Pre-existing internal medical conditions such as severe unstable heart disease, restrictive lung disease, symptomatic severe anemia, poorly controlled hypertension, poorly controlled diabetes, poorly controlled thyroid disease, and other similar conditions.
  • Pregnancy-related conditions such as early rupture of membranes, signs of preterm labor, incomplete cervix closure, history of cervical cerclage, habitual miscarriage, and previous history of preterm birth.
  • History of spinal or pelvic surgery
  • Known pelvic pain before pregnancy, such as lumbar or pelvic fractures or chronic pain caused by previous surgery
  • Clear diagnosis of pre-pregnancy back pain causes, such as herniated discs or nerve root diseases
  • Regular use of pain relief medications before pregnancy, such as acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs), morphine, and platelet-rich plasma (PRP) therapy
  • Regular weight training habit before enrollment (at least twice a week)
  • Not planning to give birth at National Taiwan University Hospital
  • Already participating in other interventional clinical trials.

结局指标

主要结局

PGQ score

时间窗: change of the PGQ score between the first trimester (before GA 14 weeks) and the third trimester before delivery (GA 35 to 36+6 weeks)

The main evaluation indicators will include the PGQ activity assessment to evaluate the impact of pelvic girdle pain on daily life, and the PGQ symptom assessment to evaluate the severity of symptoms. These indicators will be used to assess whether weight training during pregnancy improves pelvic girdle pain.

次要结局

  • Cervical length(difference of the cervical length between the first trimester (before GA 14 weeks) and the third trimester (GA 35 to 36+6 weeks) of the pregnancy)
  • Duration of the first stage of labor(During labor)
  • Duration of the second stage of labor(During labor)

研究者

发起方
National Taiwan University Hospital Hsin-Chu Branch
申办方类型
Other
责任方
Sponsor

研究点 (1)

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