Impact of Exercise on Body Composition in Premature Infants

NCT ID: NCT01386190

Last Updated: 2021-01-25

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2011-06-30

Brief Summary

This research consists of a novel intervention designed to increase physical activity of premature babies in their first year of life. The potential beneficial impact of augmented physical activity on:

1. Body composition

2. Associated biochemical and cellular mechanisms of growth and inflammation

3. Quality of maternal care will be measured

Detailed Description

Premature birth is recognized as the single most important health problem in maternal child health in the US. Paradoxically, both failure to thrive and obesity are now known to be associated with prematurity, as are osteopenia (a condition where bone mineral density is lower than normal) and increased risk of fracture, and increased risk of cardiovascular disease later in life. We lack cohesive approaches to mitigate these profound threats to health. Despite promising new research demonstrating that physical activity can stimulate the growth of muscle and bone even during intrauterine life (perhaps through metabolic programming), there have been very few attempts to implement and study physical activity interventions in the premature baby.

The challenges are substantial and include:

• measuring body composition
• assessing physical activity
• engaging caregivers as partners in the intervention
• identifying plausible and testable biological mechanisms
• designing interventions that actually increase physical activity and match the rapid pace of motor development early in life

A developmentally dynamic physical activity intervention has been designed and pilot tested-one that engages the caregiver as a partner. Using techniques and tools as far-ranging as Dual X-ray Absorbiometry (DXA), smart phones, doubly labeled water, and lightweight, wireless accelerometers developed specifically for this purpose, the working hypothesis is that the one-year intervention will augment lean body mass (primary outcome variable) and improve bone mineralization and the ratio of lean to fat tissue (secondary outcome variables). The study will gauge the impact of the physical activity intervention on the balance between circulating anabolic mediators (insulin-like growth factor-I and growth hormone binding protein) and inflammation-associated cytokines (interleukin-6, and interleukin-1 receptor antagonist), which antagonize muscle and bone growth.

We will additionally:

1. begin to explore how physical activity influences circulating endothelial progenitor cells, which are increasingly viewed as markers of vascular health very early in life

2. take advantage of this prospective, interventional study to explore potential genetic determinants of growth in babies born prematurely.

3. Finally, any study involving the premature infant and the data associated with it must be viewed in light of the critical relationship between the mother and baby.

The potential broad impact of early life interventions has been recently demonstrated by the success of the "Back-To-Sleep" campaign in mitigating sudden infant death syndrome. Should the positive effects of augmented exercise on body composition be supported, we would then anticipate widespread benefit in preventing long-term health consequences of prematurity at relatively low cost.

Conditions

Body Composition, Beneficial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Exercise Group

Caregivers will be taught progressive exercises to use with their infants from hospital discharge to 1 year of age.

Group Type: EXPERIMENTAL

Exercise/Social Behavioral

Intervention Type: OTHER

Both the control and the intervention groups will be guided in implementing structured social interaction. In the intervention group, the structured interaction will incorporate augmented physical activities, while in the control group, the structured interaction will consist of predominantly social activities such as the caregiver reading or singing to the baby. The duration of the structured activities for both groups will be the same.

Control

Both the control and the intervention groups will be guided in implementing structured social interaction.In the control group, the structured interaction will consist of predominantly social activities such as the caregiver reading or singing to the baby. The duration of the structured activities for both groups will be the same.

Group Type: ACTIVE_COMPARATOR

Exercise/Social Behavioral

Intervention Type: OTHER

Both the control and the intervention groups will be guided in implementing structured social interaction. In the intervention group, the structured interaction will incorporate augmented physical activities, while in the control group, the structured interaction will consist of predominantly social activities such as the caregiver reading or singing to the baby. The duration of the structured activities for both groups will be the same.

Interventions

Exercise/Social Behavioral

Both the control and the intervention groups will be guided in implementing structured social interaction. In the intervention group, the structured interaction will incorporate augmented physical activities, while in the control group, the structured interaction will consist of predominantly social activities such as the caregiver reading or singing to the baby. The duration of the structured activities for both groups will be the same.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Infant is a healthy, growing NICU inpatient.
• Caregiver ≥18 years of age
• Infant gestational age at birth <29weeks
• Infant gestational age at time of study recruitment >34 wks, on full feeds and nearing discharge

Exclusion Criteria

• Significant lung disease of prematurity requiring supplemental oxygen or corticosteroids at discharge
• Significant intraventricular hemorrhage, grade III -IV
• Necrotizing entrocolitis
• Tracheostomy
• Bone Diseases

• Osteogenesis Imperfecta
• Hip or knee joint anomalies
• Arthrogryposis
• Fractures
• Skin disorders (e.g., Erythematus Bullosis)
• Symptomatic congestive heart disease
• Any other conditions or congenital anomalies likely to severely impact the ability of the premature baby and caregiver to participate in a demanding study

• Minimum Eligible Age: 29 Weeks
• Maximum Eligible Age: 34 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dan M. Cooper, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Locations

University of California, Irvine Douglas Hospital

Orange, California, United States

Countries

United States

Other Identifiers

HS # 2011-8156

Identifier Type: OTHER

Identifier Source: secondary_id

R01H110163-01A1 [2011-8156]

Identifier Type: -

Identifier Source: org_study_id