Impact of Exercise on Body Composition in Premature Infants: New Approaches
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in Lean Body Mass (LBM) as assessed by Dual X-ray Absorbiometry(DXA) at age 34-40 weeks gestational age and 86-92 weeks of age
研究概览
简要总结
This research consists of a novel intervention designed to increase physical activity of premature babies in their first year of life. The potential beneficial impact of augmented physical activity on:
- Body composition
- Associated biochemical and cellular mechanisms of growth and inflammation
- Quality of maternal care will be measured
详细描述
Premature birth is recognized as the single most important health problem in maternal child health in the US. Paradoxically, both failure to thrive and obesity are now known to be associated with prematurity, as are osteopenia (a condition where bone mineral density is lower than normal) and increased risk of fracture, and increased risk of cardiovascular disease later in life. We lack cohesive approaches to mitigate these profound threats to health. Despite promising new research demonstrating that physical activity can stimulate the growth of muscle and bone even during intrauterine life (perhaps through metabolic programming), there have been very few attempts to implement and study physical activity interventions in the premature baby.
The challenges are substantial and include:
- measuring body composition
- assessing physical activity
- engaging caregivers as partners in the intervention
- identifying plausible and testable biological mechanisms
- designing interventions that actually increase physical activity and match the rapid pace of motor development early in life
A developmentally dynamic physical activity intervention has been designed and pilot tested-one that engages the caregiver as a partner. Using techniques and tools as far-ranging as Dual X-ray Absorbiometry (DXA), smart phones, doubly labeled water, and lightweight, wireless accelerometers developed specifically for this purpose, the working hypothesis is that the one-year intervention will augment lean body mass (primary outcome variable) and improve bone mineralization and the ratio of lean to fat tissue (secondary outcome variables). The study will gauge the impact of the physical activity intervention on the balance between circulating anabolic mediators (insulin-like growth factor-I and growth hormone binding protein) and inflammation-associated cytokines (interleukin-6, and interleukin-1 receptor antagonist), which antagonize muscle and bone growth.
We will additionally:
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
- Single (Investigator)
入排标准
- 年龄范围
- 29 Weeks 至 34 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infant Inclusion criteria:
- •Infant is a healthy, growing NICU inpatient.
- •Caregiver ≥18 years of age
- •Infant gestational age at birth <29weeks
- •Infant gestational age at time of study recruitment >34 wks, on full feeds and nearing discharge
排除标准
- •Significant lung disease of prematurity requiring supplemental oxygen or corticosteroids at discharge
- •Significant intraventricular hemorrhage, grade III -IV
- •Necrotizing entrocolitis
- •Tracheostomy
- •Bone Diseases
- •Osteogenesis Imperfecta
- •Hip or knee joint anomalies
- •Arthrogryposis
- •Fractures
- •Skin disorders (e.g., Erythematus Bullosis)
- •Symptomatic congestive heart disease
- •Any other conditions or congenital anomalies likely to severely impact the ability of the premature baby and caregiver to participate in a demanding study
研究组 & 干预措施
Exercise Group
Caregivers will be taught progressive exercises to use with their infants from hospital discharge to 1 year of age.
干预措施: Exercise/Social Behavioral (Other)
Control
Both the control and the intervention groups will be guided in implementing structured social interaction.In the control group, the structured interaction will consist of predominantly social activities such as the caregiver reading or singing to the baby. The duration of the structured activities for both groups will be the same.
干预措施: Exercise/Social Behavioral (Other)
结局指标
主要结局
Change in Lean Body Mass (LBM) as assessed by Dual X-ray Absorbiometry(DXA) at age 34-40 weeks gestational age and 86-92 weeks of age
时间窗: ages: 34-40 weeks gestational age and 86 - 92 weeks of age
LBM (lean body mass) will be measured and compared at the UCI Institute for Clinical and Translational Science. Dual X-ray Absorbiometry (DXA) scan to measure lean mass will be done using a whole body fan-beam scanner (Hologic QDR Discovery-A Hologic Inc., Bedford MA)at age 34-40 weeks gestational age and again at 86-92 weeks of age
次要结局
- Energy expenditure 2 Total Energy Expenditure as assessed by Doubly Labeled Water(age: 86-92 weeks)
- Blood sample(ages: 34-40 weeks gestational age and 86 - 92 weeks of age)
- Energy Expenditure 1 Accelerometer three time points in the study(ages: 34-40 weeks gestational age, 52-68 weeks and 86 - 92 weeks of age)
- Diet Assessments(ages: 34-40 weeks gestational age, 52-68 weeks and 86 - 92 weeks of age)
- Quality of Caregiver-Child Interaction(ages: 34-40 weeks gestational age and 86 to 92 weeks of age)
- TIMP/AIMS(ages: 34-40 weeks gestational age and 86 to 92 weeks of age)