Training in Exercise Activities and Motion for Growth

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-12-31

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.

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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.

Conditions

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Single Ventricle Physiology

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Passive range of motion (ROM) exercise

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

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

Minimum Eligible Age

1 Day

Maximum Eligible Age

30 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No