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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-23

Study Completion Date

2024-12-30

Brief Summary

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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.

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Detailed Description

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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

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Congenital Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Passive range-of-motion

daily assisted exercise sessions lasting 15-20 minutes, conducted by trained physical therapists, for up to 21 days prior to hospital discharge, plus standard of care

Group Type EXPERIMENTAL

passive range of motion exercise therapy

Intervention Type OTHER

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.

Standard of care

standard of care at study site

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* hospitalized infants with HLHS or other single RV anomalies
* \>=37 weeks gestation
* \<=35 days of age
* planned Norwood procedure (or hybrid leading to Norwood within 35 days)
* parent or guardian willing to comply with protocol and provide written informed consent

Exclusion Criteria

* birthweight \<3rd percentile for gestational age
* chromosomal or recognizable phenotypic syndrome of non-cardiac congenital abnormalities associated with growth failure (for example Trisomy, Noonan, or Turner syndromes)
* non-cardiac diagnosis associated with growth failures
* listed for cardiac transplant
* anticipated discharge within 14 days of screening

Maximum Eligible Age

35 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No