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??

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.

Study Overview

• Status: Unknown
• Conditions: Osteopenia of Prematurity
• Intervention / Treatment: Behavioral: passive physical activity

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.

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Kfar Saba, Israel, 44281
    • Recruiting
    • Meir Medical Center
    • Contact: Ita Litmanovitz, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 days to 2 weeks (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: physical activity once a day	Behavioral: passive 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; Other Names: passive range-of-motion exercise against passive resistance.
Experimental: physical activity twice a day	Behavioral: passive 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; Other Names: passive range-of-motion exercise against passive resistance.
No Intervention: control	Behavioral: passive 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; Other Names: passive range-of-motion exercise against passive resistance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Bone Speed of sound	during hospitalization

Secondary Outcome Measures

Outcome Measure	Time Frame
Anthropometric measurements	During hospitalization

Collaborators and Investigators

• Sponsor: Meir Medical Center

Publications and helpful links

General Publications

• Moyer-Mileur L, Luetkemeier M, Boomer L, Chan GM. Effect of physical activity on bone mineralization in premature infants. J Pediatr. 1995 Oct;127(4):620-5. doi: 10.1016/s0022-3476(95)70127-3.

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Anticipated): June 1, 2012
• Study Completion (Anticipated): September 1, 2012

Study Registration Dates

• First Submitted: December 31, 2009
• First Submitted That Met QC Criteria: January 4, 2010
• First Posted (Estimate): January 5, 2010

Study Record Updates

• Last Update Posted (Estimate): March 16, 2012
• Last Update Submitted That Met QC Criteria: March 15, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: osteopenia; very low birthweight infants; bone speed of sound; quantitative ultrasound
• Additional Relevant MeSH Terms: Metabolic Diseases; Body Weight; Musculoskeletal Diseases; Bone Diseases; Birth Weight; Bone Diseases, Metabolic
• Other Study ID Numbers: 060-09

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No