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临床试验/NCT03079258
NCT03079258Unknown不适用

Can Physical Activity During Pregnancy Improve Maternal and Offspring Vascular Health?

Liverpool John Moores University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年4月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
20
试验地点
2
主要终点
Change in Vascular Function

研究概览

简要总结

The aim of this study is to determine the effect of aerobic exercise on maternal and offspring vascular health.

详细描述

The study will comprise of a randomised pilot trial to assess the effect of a moderate intensity exercise intervention on maternal and offspring vascular health. Participants will be recruited in the first trimester (T1, 10-12 weeks' gestation), and will be randomized to either a 24-week, structured and partially supervised, gym-based exercise intervention beginning in trimester 2 (T2) through to trimester 3 (T3), or a non-exercise control group who receive normal clinical care. The inclusion of this non-exercise control group is critical in allowing us to create an understanding of the adaptation of the vascular system during a normal (non-exercising) pregnancy, and also determining the physical activity and sedentary behaviour engaged in during normal healthy pregnancy. All participants will be asked to attend the laboratory at Liverpool John Moores University on 4 separate occasions synchronised with the end point of each trimester and then within four weeks of delivery. Maternal vascular health, physical activity, sedentary behaviour and fitness will be assessed during each time point throughout pregnancy while the fourth visit will comprise of an offspring vascular assessment. The investigators will also gain information on delivery outcomes including pre-term delivery, complications during labour, induction of labour, caesarean sections and post-partum haemorrhage via medical notes at the Liverpool Women's NHS Foundation Trust.

研究设计

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

盲法说明

Collected data at each time point will be blinded to the outcome assessor.

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Healthy pregnant female
  • No history of cardiovascular disease, gestational diabetes or pre-eclampsia
  • Single gestation
  • Not on medication affecting cardiovascular health
  • A non-smoker for at least 6 months
  • Participating in structured exercise <twice/week
  • BMI <30kg/m^2 -

排除标准

  • Royal College of Obstetricians and Gynaecologists (RCOG) contraindications for pregnancy
  • Pregnant by in-vitro fertilisation (IVF)exercise
  • BMI >30kg/m^2
  • >45 years old
  • Structured exercise >twice/week
  • Multiple gestation
  • Disability preventing ambulation
  • Currently smoking or smoking within past 6 months prior to pregnancy
  • Non-English speaking women

研究组 & 干预措施

Exercise

Experimental

Participants randomized to the exercise intervention group will be required to complete a 24-wk partially supervised exercise programme consisting of 3-4 sessions per week of 15 minutes progressing to 30 minutes over time.

干预措施: Exercise (Other)

Control

No Intervention

Those randomized to the control group will continue with their standard care.

结局指标

主要结局

Change in Vascular Function

时间窗: Change from baseline at week 24 and 36 of pregnancy

Vascular function will be measured via endothelial-dependent flow-mediated dilation (FMD) of the brachial and femoral arteries and reported as percentage change.

次要结局

  • Change in Physical activity(Change from baseline at week 24 and 36 of pregnancy)
  • Change in Sedentary behaviour(Change from baseline at week 24 and 36 of pregnancy)
  • Incidence of Pregnancy specific outcomes(Following delivery and within 4 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Áine Brislane

Principal Investigator Áine Brislane

Liverpool John Moores University

研究点 (2)

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