Clinical trial NCT01917084: Training in Exercise Activities and Motion for Growth
Official title: Training in Exercise Activities and Motion for Growth (A Study Conducted by the Pediatric Heart Network)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Single Ventricle Physiology
Keywords: Passive range of motion
Single ventricle
Infants
Congenital heart disease
Lead sponsor: Carelon Research
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2013-08-06
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: 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
timeFrame: during the intervention and for one hour afterwards, daily up to 21 days
measure: Feasibility of a Passive ROM Exercise Program, Administered up to 21 Days After the Norwood Procedure, in Infants With Single Ventricle Physiology
timeFrame: during intervention, up to 21 days
measure: 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
timeFrame: during the intervention and for one hour afterwards, daily up to 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Houston
country: United States
facility: Baylor College of Medicine - Texas Children's Hospital
state: Texas
city: Salt Lake City
country: United States
facility: Utah Primary Children's Medical Center
state: Utah
Study officials:
affiliation: Utah Primary Children's Medical Center
name: Linda Lambert, MSN, c-FNP
role: STUDY_CHAIR
References: