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Completed

NCT Number: NCT01917084

Training in Exercise Activities and Motion for Growth

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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Key information

Conditions

Single Ventricle Physiology Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Univentricular Heart

Age range

1 day–30 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Passive range of motion (ROM) exercise

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

Primary outcomes

  1. 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

    Time frame: 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

  2. Feasibility of a Passive ROM Exercise Program, Administered up to 21 Days After the Norwood Procedure, in Infants With Single Ventricle Physiology

    Time frame: 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

  3. 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Carelon Research

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Acronym: T4G

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 6, 2013
Registry last updated
Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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