Training in Exercise Activities and Motion for Growth (TEAM 4 Growth)
|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: NCT01917084|
Recruitment Status : Completed
First Posted : August 6, 2013
Last Update Posted : March 19, 2015
|Condition or disease||Intervention/treatment||Phase|
|Single Ventricle Physiology||Other: Passive range of motion (ROM) exercise||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Training in Exercise Activities and Motion for Growth (A Study Conducted by the Pediatric Heart Network)|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||December 2014|
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
- 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.
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): 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|