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临床试验/NCT01042639
NCT01042639Unknown不适用

The Effect of Physical Activity on Bone Strength and Immune System in Very Low Birth Weight Infants: is More Really Better??

Meir Medical Center1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2010年1月1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
45
试验地点
1
主要终点
Bone Speed of sound

研究概览

简要总结

Studies have demonstrated that brief (5-10 min a day) passive range-of-motion exercise is beneficial for bone development in very low birth weight (VLBW) preterm infants. However, the optimal duration and frequency of exercise for bone development in preterm infants is yet unknown.

The effect of exercise on the immune system was widely studied in adult and children. Exercise induces increase in IL-6, IL-10, and IL1ra. In adult even 10 minutes of flexion and extension of the wrist cause systemic increase in IL-6. The effect of physical activity on pro and anti inflammatory cytokines in preterm infant was not studied.

Objectives:

  1. To assess weather twice daily exercise intervention will enhance bone strength compared to once a day intervention
  2. To evaluate the effect of a single exercise intervention on inflammatory mediators.

Methods:

Single center (Meir Medical Center), double blind, randomized control study.

详细描述

Infants will be randomly assigned to one of 3 study groups. Group 1 - physical activity once a day. Group 2 - physical activity twice a day and group 3 - control.

The physical activity program is based on the Moyer-Mileur et al protocol (1). Briefly, this protocol involves extension and flexion range-of-motion exercise against passive resistance of both the upper and lower extremities. Both extension and flexion were performed five times at the wrist, elbow, shoulder, ankle, knee, and hip joints (about 10 minutes for each session). Infant in group 1 have the physical activity intervention once a day, 5 days a week. Infant in group 2 will have the same physical activity intervention twice a day, five times a week. Infant in group 3, the control group will have a similar time (10 minutes) of daily interactive periods of holding and stroking without range-of-motion activity.

The physical activity will be done by the same person (the NICU physiotherapist) Growth parameters, and bone strength, will be measured at enrollment and every 2 weeks till discharge.

Bone strength assessment will be determined by quantitative ultrasound measurement of bone speed of sound (SOS) at the middle left tibial shaft (Sunlight Omnisense Premier). All measurements will be performed by the same person, who will be blinded to the group assignment.

Cytokines study In a sub-group of patients who will have arterial line at enrollment blood sample ( 0.6 CC) will be drawn before and immediately following activity for assessment of proinflammatory (IL-6) and anti-inflammatory ( IL1-ra) cytokines. Samples will be kept at -20º C and will be analyzed after completion of the study.

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
Triple (Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
3 Days 至 14 Days(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Birth weight<1500gr, appropriate for gestational age.
  • •After initial cardio-respiratory stabilization
  • •< 14 days postnatal age
  • •Written parental informed consent

排除标准

  • •Intrauterine growth retardation
  • •Severe central nervous system disorder (including IVH grade 3-4).
  • •Congenital anomalies/chromosomal abnormalities.
  • •Congenital bone disease.

研究组 & 干预措施

physical activity once a day

Active Comparator

干预措施: passive physical activity (Behavioral)

physical activity twice a day

Experimental

干预措施: passive physical activity (Behavioral)

control

No Intervention

干预措施: passive physical activity (Behavioral)

结局指标

主要结局

Bone Speed of sound

时间窗: during hospitalization

次要结局

  • Anthropometric measurements(During hospitalization)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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