Training in Exercise Activities and Motion for Growth (TEAM 4 Growth) RCT (T4G RCT)

July 2, 2024 updated by: Carelon Research

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
144

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • OT
      • Toronto, OT, Canada, M5G1X8
        • The Hospital for Sick Children
  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Children's Healthcare of Atlanta / Emory University
    • Indiana
      • Indianapolis, Indiana, United States, 46208
        • Riley Children's Hospital of Indiana
    • Massachusetts
      • Boston, Massachusetts, United States, 02458
        • Boston Children's Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • Ohio
      • Cincinnati, Ohio, United States, 45227
        • Cincinnati Children's Hospital Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19083
        • Children's Hospital of Philadelphia
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Texas
      • Houston, Texas, United States, 77030
        • Texas Children's Hospital / Baylor
    • Utah
      • Salt Lake City, Utah, United States, 84116
        • Primary Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 4 weeks (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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
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.
No Intervention: Standard of care
standard of care at study site

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
weight-for-age z-score
Time Frame: 4 months of age or superior cavopulmonary connection (SCPC) evaluation clinic visit, whichever comes first
weight-for-age z-score
4 months of age or superior cavopulmonary connection (SCPC) evaluation clinic visit, whichever comes first

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
length-for-age z-score
Time Frame: 4 months of age or superior cavopulmonary connection (SCPC) evaluation clinic visit, whichever comes first
length-for-age z-score
4 months of age or superior cavopulmonary connection (SCPC) evaluation clinic visit, whichever comes first
head circumference-for-age z-score
Time Frame: 4 months of age or superior cavopulmonary connection (SCPC) evaluation clinic visit, whichever comes first
head circumference-for-age z-score
4 months of age or superior cavopulmonary connection (SCPC) evaluation clinic visit, whichever comes first
Tests of Infant Motor Performance (TIMP)
Time Frame: Time of discharge from hospital following Norwood Procedure, approximately 3-4 weeks
Tests of Infant Motor Performance (TIMP)
Time of discharge from hospital following Norwood Procedure, approximately 3-4 weeks
Tests of Infant Motor Performance (TIMP)
Time Frame: 4 months of age or superior cavopulmonary connection (SCPC) evaluation clinic visit, whichever comes first
Tests of Infant Motor Performance (TIMP)
4 months of age or superior cavopulmonary connection (SCPC) evaluation clinic visit, whichever comes first
DXA
Time Frame: 4 months of age or superior cavopulmonary connection (SCPC) evaluation clinic visit, whichever comes first
bone mineral density as measured by dual-energy X-ray absorptiometry (DXA) scan
4 months of age or superior cavopulmonary connection (SCPC) evaluation clinic visit, whichever comes first
Neonatal Intensive Care Unit (NICU) Network Neurobehavioral Scale (NNNS) subdomain scores
Time Frame: Post-operative day 21 or discharge, whichever comes first
NNNS subdomain scores; some score ranges from 1-9, but depends on each score whether higher is good or bad--for example, higher attention score is good, higher stress abstinence is bad; the rest of the scores range from 0-1 (yes/no)
Post-operative day 21 or discharge, whichever comes first

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Carelon Research

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Heart, Lung, and Blood Institute (NHLBI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 23, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 3, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 8, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PHN T4G RCT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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