Training in Exercise Activities and Motion for Growth (TEAM 4 Growth)
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.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Training in Exercise Activities and Motion for Growth (A Study Conducted by the Pediatric Heart Network)|
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
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.
|Study Start Date:||June 2013|
|Estimated Study Completion Date:||November 2014|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Experimental: Passive range of motion (ROM) exercise
A 10 - 15 minute passive range of motion (ROM) exercise program will be administered daily during hospitalization for up to 21 days or until discharge (whichever comes first).
Other: Passive range of motion (ROM) exercise
After their Norwood surgery, stable subjects will undergo passive ROM exercise therapy for up to 21 consecutive days or until hospital discharge, whichever comes first. Subjects will have completed the study after their anthropometric measurements are collected at 3 months of age
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01917084
|United States, Pennsylvania|
|Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, Texas|
|Baylor College of Medicine - Texas Children's Hospital|
|Houston, Texas, United States, 77030|
|United States, Utah|
|Utah Primary Children's Medical Center|
|Salt Lake City, Utah, United States, 84132|
|Study Chair:||Linda Lambert, MSN, c-FNP||Utah Primary Children's Medical Center|