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

NCT01042639 | Unknown DMC

• 1 other identifier: 060-09
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Conditions

Osteopenia of Prematurity

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Bone Speed of sound

  during hospitalization

Secondary Outcomes (1)

• Anthropometric measurements

  During hospitalization

Study Arms (3)

physical activity once a day

ACTIVE COMPARATOR

Behavioral: passive physical activity

physical activity twice a day

EXPERIMENTAL

Behavioral: passive physical activity

control

NO INTERVENTION

Behavioral: passive physical activity

Interventions

passive physical activity BEHAVIORAL

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

Also known as: passive range-of-motion exercise against passive resistance.

control; physical activity once a day; physical activity twice a day

Eligibility Criteria

• Age: 3 Days - 14 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Meir Medical Center: lead

Study Sites (1)

Meir Medical Center

Kfar Saba, 44281, Israel

RECRUITING

Related Publications (1)

• 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.

  PMID: 7562289 BACKGROUND

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Ita Litmanovitz, MD

  Meir Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ita Litmanovitz, MD

CONTACT

+972-9-7471554; litmani@clalit.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2009
• First Posted: January 5, 2010
• Study Start: January 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: September 1, 2012
• Last Updated: March 16, 2012

Record last verified: 2012-03

Locations

IL (1)