Osteopenia of Prematurity Clinical Trial
Official title:
The Effect of Physical Activity on Bone Strength and Immune System in Very Low Birth Weight Infants: is More Really Better??
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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