Training in Exercise Activities and Motion for Growth

N/ACompletedNCT01917084

Carelon Research20 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Single Ventricle Physiology

Interventions

Passive range of motion (ROM) exerciseOTHER

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

Eligibility

Sex: ALLMin age: 1 DayMax age: 30 Days

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: during the intervention and for one hour afterwards, daily up to 21 days

Data from ClinicalTrials.gov

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