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Training in Exercise Activities and Motion for Growth (TEAM 4 Growth)

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ClinicalTrials.gov Identifier: NCT01917084
Recruitment Status : Completed
First Posted : August 6, 2013
Last Update Posted : March 19, 2015
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
New England Research Institutes

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Single Ventricle Physiology Other: Passive range of motion (ROM) exercise Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Training in Exercise Activities and Motion for Growth (A Study Conducted by the Pediatric Heart Network)
Study Start Date : June 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : December 2014

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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).
 Other: 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


Outcome Measures
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Primary Outcome Measures :
  1. Safety of a passive ROM exercise program, administered up to 21 days after the Norwood procedure, in infants with single ventricle physiology [ Time Frame: Daily for 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: Daily for up to 21 days ]

    Ability to complete the exercise protocol will be measured in three categories:

    • High completion is defined as >75% of the days on which 75% of the intervention was performed.
    • Medium completion is defined as 50-75% of the days on which 75% of the intervention was performed.
    • Low completion is defined as <50% of the days on which 75% of the intervention was performed.


Eligibility Criteria
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Ages Eligible for Study:   up to 30 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01917084


Locations
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Baylor College of Medicine - Texas Children's Hospital
Houston, Texas, United States, 77030
United States, Utah
Utah Primary Children's Medical Center
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
New England Research Institutes
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Study Chair: Linda Lambert, MSN, c-FNP Utah Primary Children's Medical Center
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Pediatric Heart Network  This link exits the ClinicalTrials.gov site

Responsible Party: New England Research Institutes
ClinicalTrials.gov Identifier: NCT01917084     History of Changes
Other Study ID Numbers: U10HL068270 ( U.S. NIH Grant/Contract )
U01HL068270 ( U.S. NIH Grant/Contract )
First Posted: August 6, 2013    Key Record Dates
Last Update Posted: March 19, 2015
Last Verified: December 2013

Keywords provided by New England Research Institutes:
Passive range of motion
Single ventricle
Infants
Congenital heart disease