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临床试验/NCT05394883
NCT05394883已完成不适用

The SPROUT (Pilot) Project: Starting Pregnancy With Robustness for Optimal Upward Trajectories

State University of New York - Upstate Medical University2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2020年10月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
18
试验地点
2
主要终点
Balke-Ware Submaximal Test

研究概览

简要总结

The purpose of this research is to study two different approaches to exercise during pregnancy that investigators believe will result in improved health for moms and babies. The investigators are trying to determine if the two types of exercise programs (supervised & home exercise) result in health improvements for moms and babies. The investigators also want to see if the tests and questionnaires used in the study can detect changes in a mom's aerobic fitness, quality of life (QOL), fatigue, sleep quality, depression, and weight change throughout pregnancy and 6-months after birth.

详细描述

Historically, pregnant women were advised to refrain from exercise due to concerns of maternal and fetal risk such as preterm delivery, low infant birth rate and fetal stress. Despite current research that has demonstrated substantial benefits for maternal, fetal, and infant health, only 9-15% of pregnant women meet the current physical activity recommendations. In addition, pregnancy exercise research is confounded by a lack of randomized controlled trials (RCT) that include diversity in participant demographics, specifically inner city populations, and difficulty accurately quantifying weekly exercise volume. The investigators propose a pilot RCT investigating two different approaches to exercise intervention across a spectrum of demographics that the investigators believe will result in improved exercise adherence as well as in maternal and infant health outcomes. Specific Aim #1: To determine the feasibility of two types of exercise interventions (supervised & home exercise) in terms of design, implementation and adherence. Our working hypothesis is that both supervised and home exercise interventions will be implementable as designed in pregnant women as evidenced by recruitment, eligibility, retention, follow-up and exercise adherence from 1st trimester through 6-months post-natal at a 60% rate, but that adherence to the two types of exercise interventions will differ by demographic. A secondary exploratory hypothesis is that the investigators will be able to successfully recruit and retain 50% of our pregnant women from the Syracuse Community Health Center (primarily women with lower resources). Specific Aim #2: To determine the appropriateness of the outcome measures proposed for the exercise intervention in detecting changes in maternal aerobic fitness, quality of life (QOL), fatigue, sleep quality, depression, and weight change throughout pregnancy and 6-months post-natal as measured by the Balke Ware submaximal test; SF-12 Generic Quality of Life (QOL); Multidimensional Fatigue Inventory (MFI); Pittsburgh Sleep Quality Index (PSQLI); Center for Epidemiologic Studies Depression Scale (CES-D); Edinburgh Postnatal Depression Scale (EPDS); and the Pregnancy Physical Activity Questionnaire (PPAQ). Our working hypothesis is that the above outcome measures will be able to detect changes in maternal outcome measures in both exercise groups. Because this is a feasibility study, the results will be used as preliminary data to apply for future funding and also will provide variable quantitative and qualitative data for validating interventions that can increase adherence to exercise guidelines during pregnancy in women with different ethnic and socioeconomic backgrounds.

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
None

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

  • Adult pregnant women (i.e. 18 years of age and older)
  • Low risk, singleton pregnancy
  • In first trimester of pregnancy (6 to 13 weeks gestation)
  • Without absolute contraindications to moderate intensity exercise during pregnancy as defined by the American College of Obstetricians and Gynecologists
  • Exercise clearance from OB/GYN

排除标准

  • Pregnancies greater than low risk for any reason
  • Pregnant with more than one fetus
  • Absolute exercise contraindications and/or lack of exercise clearance from OB/GYN

结局指标

主要结局

Balke-Ware Submaximal Test

时间窗: 6 months post-delivery

Used to estimate cardiovascular condition and endurance by measuring maximum oxygen uptake, known as VO2max. Comparison of the participant's heart rate and blood pressure response to exercise between measurements will assess the effect of the intervention on the participant's aerobic capacity. A reduction in heart rate or blood pressure may be consistent with improved aerobic conditioning.

The Bayley Scales of Infant Development, 4th edition

时间窗: Month 6 of infant's life

The Bayley-4 is a standardized, norm-referenced tool with subtest level scaled scores, domain level composite scores, percentile ranks, and developmental age equivalents. The investigators will utilize the cognitive and motor sections only for this study. The purpose of this outcome measure is to compare developmental trajectories over the first six months of life between the three groups (supervised exercise group, home exercise group, and control group). The highest possible score on a subtest or subdomain is 19, and the lowest possible score is 1. Scores from 8-12 are considered average.

次要结局

  • Short From-12 Generic Quality of Life(Baseline (late first trimester), late second trimester (25-26 weeks), late third trimester (37-38 weeks), and monthly through 6-months post-natal)
  • Height(Month 1, Month 2, Month 3, Month 4, Month 5, Month 6 of infant's life)
  • Multidimensional Fatigue Inventory(Baseline (late first trimester), late second trimester (25-26 weeks), late third trimester (37-38 weeks), and monthly through 6-months post-natal)
  • Pittsburgh Sleep Quality Index(Baseline (late first trimester), late second trimester (25-26 weeks), late third trimester (37-38 weeks), and monthly through 6-months post-natal)
  • Center for Epidemiologic Studies Depression Scale(Baseline (late first trimester), late second trimester (25-26 weeks), late third trimester (37-38 weeks), and monthly through 6-months post-natal)
  • Edinburgh Postnatal Depression Scale(Baseline (late first trimester), late second trimester (25-26 weeks), late third trimester (37-38 weeks), and monthly through 6-months post-natal)
  • Pregnancy Physical Activity Questionnaire(Baseline (late first trimester), late second trimester (25-26 weeks), late third trimester (37-38 weeks), and monthly through 6-months post-natal)
  • Weight(Month 1, Month 2, Month 3, Month 4, Month 5, Month 6 of infant's life)

研究者

发起方
State University of New York - Upstate Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Erin Wentz PT PhD PCS

Assistant Professor

State University of New York - Upstate Medical University

研究点 (2)

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