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

This study is currently recruiting participants.
Verified March 2012 by Meir Medical Center
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01042639
First received: December 31, 2009
Last updated: March 15, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention
Osteopenia of Prematurity
 Behavioral: passive physical activity

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • Bone Speed of sound [ Time Frame: during hospitalization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Anthropometric measurements [ Time Frame: During hospitalization ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: January 2010
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: passive range-of-motion exercise against passive resistance.

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.

  Eligibility

Ages Eligible for Study:   up to 14 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01042639

Contacts
Contact: Ita Litmanovitz, MD +972-9-7471554 litmani@clalit.org.il

Locations
Israel
Meir Medical Center Recruiting
Kfar Saba, Israel, 44281
Contact: Ita Litmanovitz, MD            
Sponsors and Collaborators
Meir Medical Center
Investigators
Principal Investigator: Ita Litmanovitz, MD Meir Medical Center
  More Information

Publications:
Moyer-Mileur L, Luetkemeler M, Boomer L, Chan GM .Effect of physical activity on bone mineralization in premature infants. J Pediatr 127:620_625,1995.

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01042639     History of Changes
Other Study ID Numbers: 060-09
Study First Received: December 31, 2009
Last Updated: March 15, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Meir Medical Center:
osteopenia
very low birthweight infants
bone speed of sound
quantitative ultrasound

Additional relevant MeSH terms:
Birth Weight
Bone Diseases, Metabolic
Body Weight
 Signs and Symptoms
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 22, 2013