Training in Exercise Activities and Motion for Growth
T4G
2 other identifiers
interventional
20
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2013
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
August 2, 2013
CompletedFirst Posted
Study publicly available on registry
August 6, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedResults Posted
Study results publicly available
January 19, 2021
CompletedFebruary 20, 2025
December 1, 2013
1.3 years
August 2, 2013
February 1, 2018
February 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Adverse Events (AEs) and Serious Adverse Events (SAEs) in a Passive ROM Exercise Program, Administered up to 21 Days After the Norwood Procedure, in Infants With Single Ventricle Physiology
* 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
during the intervention and for one hour afterwards, daily up to 21 days
Feasibility of a Passive ROM Exercise Program, Administered up to 21 Days After the Norwood Procedure, in Infants With Single Ventricle Physiology
Percentage of days with high completion, medium completion, and low completion of the intervention: * High completion is defined as \>75% of the intervention * Medium completion is defined as 50-75% of the intervention * Low completion is defined as \<50% of the intervention Percentage of days with high/medium/low completion was then calculated across all participants and days
during intervention, up to 21 days
Number of Participants With Adverse Events (AEs) in a Passive ROM Exercise Program, Administered up to 21 Days After the Norwood Procedure, in Infants With Single Ventricle Physiology
• Number of participants with adverse events (AE), of any type, occurring during and for one hour after the daily study intervention is concluded
during the intervention and for one hour afterwards, daily up to 21 days
Study Arms (1)
Passive range of motion (ROM) exercise
EXPERIMENTALA 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).
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Baylor College of Medicine - Texas Children's Hospital
Houston, Texas, 77030, United States
Utah Primary Children's Medical Center
Salt Lake City, Utah, 84132, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Felicia Trachtenberg
- Organization
- New England Research Institutes
Study Officials
- STUDY CHAIR
Linda Lambert, MSN, c-FNP
Utah Primary Children's Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 2, 2013
First Posted
August 6, 2013
Study Start
June 1, 2013
Primary Completion
September 1, 2014
Study Completion
December 1, 2014
Last Updated
February 20, 2025
Results First Posted
January 19, 2021
Record last verified: 2013-12