We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01042639
Recruitment Status : Unknown
Verified March 2012 by Meir Medical Center.
Recruitment status was:  Recruiting
First Posted : January 5, 2010
Last Update Posted : March 16, 2012
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center

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.


Condition or disease Intervention/treatment
Osteopenia of Prematurity 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  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, 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??
Study Start Date : January 2010
Estimated Primary Completion Date : June 2012
Estimated Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 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.



Primary Outcome Measures :
  1. Bone Speed of sound [ Time Frame: during hospitalization ]

Secondary Outcome Measures :
  1. Anthropometric measurements [ Time Frame: During hospitalization ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 14 Days   (Child)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01042639     History of Changes
Other Study ID Numbers: 060-09
First Posted: January 5, 2010    Key Record Dates
Last Update Posted: March 16, 2012
Last Verified: March 2012

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
Metabolic Diseases