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The Effect of Physical Activity on Bone Mineralization and Immune System in Very Low Birth Weight Infants

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01042639
Enrollment
45
Registered
2010-01-05
Start date
2010-01-31
Completion date
2012-09-30
Last updated
2012-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteopenia of Prematurity

Keywords

osteopenia, very low birthweight infants, bone speed of sound, quantitative ultrasound

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALpassive physical activity

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

Sponsors

Meir Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
3 Days to 14 Days
Healthy volunteers
No

Inclusion criteria

1. Birth weight\<1500gr, appropriate for gestational age. 2. After initial cardio-respiratory stabilization 3. \< 14 days postnatal age 4. Written parental informed consent

Exclusion criteria

1. Intrauterine growth retardation 2. Severe central nervous system disorder (including IVH grade 3-4). 3. Congenital anomalies/chromosomal abnormalities. 4. Congenital bone disease.

Design outcomes

Primary

MeasureTime frame
Bone Speed of soundduring hospitalization

Secondary

MeasureTime frame
Anthropometric measurementsDuring hospitalization

Countries

Israel

Contacts

Primary ContactIta Litmanovitz, MD
litmani@clalit.org.il+972-9-7471554

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026