Clinical Trial: Training in Exercise Activities and Motion for Growth

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Training in Exercise Activities and Motion for Growth (A Study Conducted by the Pediatric Heart Network)

Brief Summary: To determine if an exercise program of passive range of motion (ROM) is safe and feasible in infants with single ventricle (SV) physiology after their Norwood procedure.

Detailed Summary: This is a non-randomized pilot study to evaluate the safety and feasibility of an exercise program in hospitalized infants with single ventricle physiology. Following the Norwood procedure, the intervention will be administered for up to 21 days or until discharge, whichever comes first. Data will be collected daily during hospitalization and at a follow-up visit at 3 months of age. Sources of data will include medical record review. Twenty subjects will be enrolled at three Pediatric Heart Network study sites (Utah Primary Children's Hospital, Children's Hospital of Philadelphia and Texas Children's Hospital). Subjects will be recruited following Institutional Review Board (IRB) approval at each institution and parental/legal guardian consent.
Sponsor: New England Research Institutes

Current Primary Outcome:

  • Safety of a passive ROM exercise program, administered up to 21 days after the Norwood procedure, in infants with single ventricle physiology [ Time Frame: Daily for up to 21 days ]
    • Number of adverse events (AE), of any type, occurring during and for one hour after the daily study intervention is concluded
    • Number of AEs that are possibly or probably related to the intervention occurring during and for one hour after the daily study intervention is concluded
    • Number of Serious Adverse Events (SAEs) possibly or probably related to the intervention occurring at any time during the 21 day intervention period
  • Feasibility of a passive ROM exercise program, administered up to 21 days after the Norwood procedure, in infants with single ventricle physiology [ Time Frame: Daily for up to 21 days ]

    Ability to complete the exercise protocol will be measured in three categories:

    • High completion is defined as >75% of the days on which 75% of the intervention was performed.
    • Medium completion is defined as 50-75% of the days on which 75% of the intervention was performed.
    • Low completion is defined as <50% of the days on which 75% of the intervention was performed.


Original Primary Outcome:

  • Safety of a passive ROM exercise program, administered up to 21 days after the Norwood procedure, in infants with single ventricle physiology [ Time Frame: Daily for up to 21 days ]
    • Number of adverse events (AE), of any type, occurring during and for one hour after the daily study intervention is concluded
    • Number of AEs that are possibly or probably related to the intervention occurring during and for one hour after the daily study intervention is concluded
    • Number of SAEs possibly or probably related to the intervention occurring at any time during the 21 day intervention period
  • Feasibility of a passive ROM exercise program, administered up to 21 days after the Norwood procedure, in infants with single ventricle physiology [ Time Frame: Daily for up to 21 days ]

    Ability to complete the exercise protocol will be measured in three categories:

    • High completion is defined as >75% of the days on which 75% of the intervention was performed.
    • Medium completion is defined as 50-75% of the days on which 75% of the intervention was performed.
    • Low completion is defined as <50% of the days on which 75% of the intervention was performed.


Current Secondary Outcome:

Original Secondary Outcome:

Information By: New England Research Institutes

Dates:
Date Received: August 2, 2013
Date Started: June 2013
Date Completion:
Last Updated: March 17, 2015
Last Verified: December 2013