NCT01917084

Training in Exercise Activities and Motion for Growth

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Carelon Research · Academic / Other
• Sex: All
• Age: 1 Day – 30 Days
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Single Ventricle Physiology

Interventions

Type	Name	Description
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

Timeline

• Start date: 2013-06-01
• Primary completion: 2014-09-01
• Completion: 2014-12-01
• First posted: 2013-08-06
• Last updated: 2025-02-20
• Results posted: 2021-01-19

Locations

3 sites across 1 country: United States