Training in Exercise Activities and Motion for Growth

Not Applicable

Completed

• Conditions: Single Ventricle Physiology
• Interventions: Other: Passive range of motion (ROM) exercise

• Registration Number: NCT01917084
• Lead Sponsor: Carelon Research

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.

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-08-02
• Study First Submitted QC: 2013-08-02
• Study First Posted: 2013-08-06
• Status Verified: 2013-12
• Primary Completion: 2014-09
• Study Completion: 2014-12
• Results First Submitted: 2018-02-01
• Results First Submitted QC: 2021-01-15
• Results First Posted: 2021-01-19
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Passive range of motion (ROM) exercise	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).

Primary Outcome Measures

Name	Time	Method
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	during the intervention and for one hour afterwards, daily up to 21 days	• Number of participants with adverse events (AE), of any type, occurring during and for one hour after the daily study intervention is concluded
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	during the intervention and for one hour afterwards, daily up to 21 days	* 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	during intervention, up to 21 days	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

Trial Locations

Locations (3)

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

Baylor College of Medicine - Texas Children's Hospital; 🇺🇸 Houston, Texas, United States

Utah Primary Children's Medical Center; 🇺🇸 Salt Lake City, Utah, United States