NCT04702373

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

Training in Exercise Activities and Motion for Growth: A Randomized Clinical Trial

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 144 (actual)
• Sponsor: Carelon Research · Academic / Other
• Sex: All
• Age: 35 Days
• Healthy volunteers: Not accepted

Summary

This is a Phase III randomized controlled trial of a passive ROM exercise program that will be performed in infants with HLHS and other single right ventricle anomalies following the Norwood procedure at PHN and Auxiliary Centers.

Detailed description

Growth is often impaired in infants with congenital heart disease (CHD). Nutritional interventions, drug therapy and surgical palliation have had varying degrees of success in enhancing growth. Passive ROM has improved somatic growth in preterm infants and has been demonstrated in a previous Pediatric Heart Network (PHN) to be safe and feasible in neonate's post-Norwood procedure. Improved growth may also favorably impact neurodevelopment, behavioral state, and time to hospital discharge. This study's objectives are to evaluate growth in infants with hypoplastic left heart syndrome (HLHS) or other single right ventricle (RV) anomalies after the Norwood procedure who are randomized to a passive range of motion (ROM) exercise program vs. standard of care.

Conditions

• Congenital Heart Disease

Interventions

Type	Name	Description
OTHER	passive range of motion exercise therapy	Systematic flexion-extension with gentle compression at the end of the movement is performed 10 times at the wrist, elbow, shoulder, ankle, knee, and hip joints. Ten repetitions of adduction-abduction are performed at the shoulder and hip joints.

Timeline

• Start date: 2021-02-23
• Primary completion: 2024-11-30
• Completion: 2024-12-30
• First posted: 2021-01-08
• Last updated: 2024-07-03

Locations

10 sites across 2 countries: United States, Canada