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临床试验/NCT07166822
NCT07166822招募中不适用

The Role of Mobile Apps in Promoting Cardiovascular Health and Motivation to Exercise During Pregnancy

Old Dominion University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年9月15日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
2
主要终点
Flow mediated dilation

研究概览

简要总结

The goal of this study is to determine the effectiveness of a mobile exercise app in improving cardiovascular health and motivation to exercise in pregnant women who are healthy, in their 2nd trimester, between 18-45 years age, and do not do exercise currently. The aims of this study are determine i) the effect of a mobile app (BumptUp) to increase motivation to exercise as assessed by questionnaire, and ii) the changes may occur in cardiovascular health outcomes such as increased percent Flow-Mediated Dilation (FMD), Heart Rate Variability (HRV), and decreased Pulse Wave Velocity (PWV) over an 8-week period of intervention. Researchers will compare this to pregnant women who are healthy, in their 2nd trimester, between 18-45 years age, and who will not be using the mobile app (BumptUp) for exercise. Participants who are in the experimental group will be given access to the mobile app (BumptUp) for 8 weeks. Both the control and experimental group will visit the lab for their baseline measurements (study visit 1), followed by two visits at 4 weeks (study visit 2) and 8 weeks (study visit 3) to have their heart rate variability, arterial stiffness (PWV), and vascular function (FMD) assessed. At each study visit, blood pressure, heart rate, height, and weight will also be measured. Additionally, at all three study visits, participants will fill out a questionnaire to determine motivation to exercise.

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
None

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

  • Age: 18-45 years.
  • Pregnant women who are 20-24 weeks pregnant at enrollment
  • Sedentary, as defined by completing less than 90 minutes of exercise each week.
  • Generally healthy, uncomplicated pregnancies.
  • Free of physical limitations that may interfere with alterations in daily physical activity levels.
  • Single gestation.
  • Have a smartphone
  • Under the routine medical care of an obstetrician or certified nurse midwife during their current pregnancy.
  • Women speaking English.

排除标准

  • Physician diagnosed cardiovascular/ vascular complications (heart disease, high blood pressure, Raynaud's phenomenon etc.)
  • Physician diagnosed metabolic diseases (diabetes, hypothyroidism)
  • Musculoskeletal injuries (broken bones, back pain, ankle sprain, muscle pull, etc.)
  • Medications that may impact blood vessel function such as hypertension medication (Angiotensin converting enzyme inhibitor, Angiotensin receptor blocker, Calcium channel blocker, beta blocker), lipid lowering agents (statins), Nitrates, steroids, etc.
  • Complications associated with pregnancy that would be exacerbated by exercise such as lung disease, persistent spotting/bleeding or Placental Previa, premature labor, ruptured membranes, evidence of intrauterine growth restriction, pregnancy induced hypertension or pre-eclampsia, uncontrolled epileptic fits/seizures.
  • Smoking within the previous 3 months.

结局指标

主要结局

Flow mediated dilation

时间窗: 8 weeks of intervention period

The cardiovascular health via flow mediated dilation (% change from baseline) will be assessed

次要结局

  • Arterial stiffness(8 weeks)

研究者

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

Leryn Reynolds

Associate Professor

Old Dominion University

研究点 (2)

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