Training in Exercise Activities and Motion for Growth

Single Ventricle Physiology Clinical Trial

— T4G  

Official title:

Training in Exercise Activities and Motion for Growth (A Study Conducted by the Pediatric Heart Network)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01917084
• Other study ID #: U10HL068270
• Secondary ID: U01HL068270
• Status: Completed
• Phase: N/A
• Start date: June 2013
• Est. completion date: December 2014

Study information

• Verified date: December 2013
• Source: HealthCore-NERI
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 30 Days

Eligibility

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

Related Conditions & MeSH terms

• Single Ventricle Physiology

Intervention

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

Locations

Country	Name	City	State
United States	Baylor College of Medicine - Texas Children's Hospital	Houston	Texas
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Utah Primary Children's Medical Center	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
HealthCore-NERI	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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