Training in Exercise Activities and Motion for Growth (TEAM 4 Growth)
This study has been completed.
Sponsor:
New England Research Institutes
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
New England Research Institutes
ClinicalTrials.gov Identifier:
NCT01917084
First received: August 2, 2013
Last updated: March 17, 2015
Last verified: December 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Single Ventricle Physiology |
Other: Passive range of motion (ROM) exercise |
| Study Type: | Interventional |
| 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) |
Resource links provided by NLM:
Further study details as provided by New England Research Institutes:
Primary Outcome Measures:
- 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.
| Enrollment: | 20 |
| Study Start Date: | June 2013 |
| Study Completion Date: | December 2014 |
| Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | up to 30 Days (Child) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Hospitalized infants with SV physiology
- >37 weeks gestation
- <30 days of age
- Hemodynamically stable (as defined by the attending physician) after surgical or interventional palliation with closed sternum
- Parent or guardian willing to comply with protocol and provide written informed consent
Exclusion Criteria:
- Intrauterine growth restriction
- Chromosomal or recognizable phenotypic syndrome of non-cardiac congenital abnormalities associated with growth failure (for example Trisomy, Noonan or Turner syndromes)
- Unstable hemodynamics as defined by the attending physician
- Non-cardiac diagnosis associated with growth failure
- Severe neurologic injury resulting from stroke or intracranial hemorrhage confirmed by head CT/ MRI or cranial ultrasound
- Anticipated discharge within 14 days of screening
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01917084
Please refer to this study by its ClinicalTrials.gov identifier: NCT01917084
Locations
| 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 | |
Sponsors and Collaborators
New England Research Institutes
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
| Study Chair: | Linda Lambert, MSN, c-FNP | Utah Primary Children's Medical Center |
More Information
Additional Information:
| Responsible Party: | New England Research Institutes |
| ClinicalTrials.gov Identifier: | NCT01917084 History of Changes |
| Other Study ID Numbers: | U10HL068270 U01HL068270 |
| Study First Received: | August 2, 2013 |
| Last Updated: | March 17, 2015 |
| Health Authority: | United States: Institutional Review Board United States: Data and Safety Monitoring Board |
Keywords provided by New England Research Institutes:
|
Passive range of motion Single ventricle Infants Congenital heart disease |
ClinicalTrials.gov processed this record on September 30, 2016