Training in Exercise Activities and Motion for Growth

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Single Ventricle Physiology

Intervention / Treatment
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* Other: Passive range of motion (ROM) exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 30 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Passive range of motion (ROM) exercise<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Passive range of motion, Single ventricle, Infants, Congenital heart disease