Training in Exercise Activities and Motion for Growth (T4G)

Carelon Research

Status: Completed

Conditions: Single Ventricle Physiology

Treatments: Other: Passive range of motion (ROM) exercise

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01917084

U01HL068270 (U.S. NIH Grant/Contract)

U10HL068270

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 1 to 30 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Passive range of motion (ROM) exercise

Experimental group

Description:

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).

Treatment:

Other: Passive range of motion (ROM) exercise