Passive Range of Motion - TEAM 4 Growth (Observational Study)

The purpose of this study was to see if a program of gentle physical exercise is safe and helps babies to grow after having surgery to repair their hearts. This is important because many babies born with heart defects have problems growing in the first 6-12 months of life. Problems with growth can affect the health of babies for the rest of their lives. We want to find ways to help babies have healthy growth once they are stable after surgery. The researchers in this study want to test a program of gentle exercise. There is some scientific evidence that these exercises early in life helps premature babies to grow and be more calm but this had not been tested in babies with congenital heart defects. The study enrolled 20 babies.

Who was in the study?

Hospitalized infants with Single Ventricle physiology who were >37 weeks gestation and <30 days of age who were hemodynamically stable following Norwood procedure with closed sternum.

What happened in the study?

This study included:
  1. Medical History: Each baby’s medical chart was reviewed to collect information about surgeries, medical procedures, weights and measurements, and feedings.
  2. Exercise Program: Each baby received 10-15 minutes of gentle exercise each day for as long as he or she was in the hospital or for a maximum of 21 days from a trained expert familiar with handling babies who have had surgery. 
  3. Body Measurements: Each baby’s weight was collected from the chart during the hospital stay. In addition, each baby was weighed and measured by the researchers at 3 time points:
    • Two weeks after beginning the program
    • After the 21 days of the exercise program or at hospital discharge, whichever came first
    • Three months of age

What were the results of the study?

In this pilot study, we found that the exercise program was safe and feasible. There was some evidence that the babies grew more. A larger randomized controlled trial is being planned to further compare the growth of babies who do and do not receive this exercise program.