search
Back to results

Training in Exercise Activities and Motion for Growth (T4G)

Primary Purpose

Single Ventricle Physiology

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Passive range of motion (ROM) exercise
Sponsored by
Carelon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Single Ventricle Physiology focused on measuring Passive range of motion, Single ventricle, Infants, Congenital heart disease

Eligibility Criteria

1 Day - 30 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Hospital of Philadelphia
  • Baylor College of Medicine - Texas Children's Hospital
  • Utah Primary Children's Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Passive range of motion (ROM) exercise

Arm Description

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).

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

Full Information

First Posted
August 2, 2013
Last Updated
January 15, 2021
Sponsor
Carelon Research
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
search

1. Study Identification

Unique Protocol Identification Number
NCT01917084
Brief Title
Training in Exercise Activities and Motion for Growth
Acronym
T4G
Official Title
Training in Exercise Activities and Motion for Growth (A Study Conducted by the Pediatric Heart Network)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Carelon Research
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Single Ventricle Physiology
Keywords
Passive range of motion, Single ventricle, Infants, Congenital heart disease

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Passive range of motion (ROM) exercise
Arm Type
Experimental
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Passive range of motion (ROM) exercise
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Description
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
Time Frame
during the intervention and for one hour afterwards, daily up to 21 days
Title
Feasibility of a Passive ROM Exercise Program, Administered up to 21 Days After the Norwood Procedure, in Infants With Single Ventricle Physiology
Description
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
Time Frame
during intervention, up to 21 days
Title
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
Description
• Number of participants with adverse events (AE), of any type, occurring during and for one hour after the daily study intervention is concluded
Time Frame
during the intervention and for one hour afterwards, daily up to 21 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
30 Days
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda Lambert, MSN, c-FNP
Organizational Affiliation
Utah Primary Children's Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Baylor College of Medicine - Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Utah Primary Children's Medical Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Training in Exercise Activities and Motion for Growth

We'll reach out to this number within 24 hrs