Congenital Heart DiseasePhase 3T4G RCTNCT04702373
Training in Exercise Activities and Motion for Growth (TEAM 4 Growth) RCT
A Phase 3 study testing passive range of motion exercise therapy in people with Congenital Heart Disease, run by Carelon Research at 10 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 35 days
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- passive range of motion exercise therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 23 Feb 2021to 30 Dec 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 35 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States9 sites
University of Michigan
Ann Arbor, Michigan, 48109
Children's Healthcare of Atlanta / Emory University
Atlanta, Georgia, 30322
Boston Children's Hospital
Boston, Massachusetts, 02458
Medical University of South Carolina
Charleston, South Carolina, 29425
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45227
Texas Children's Hospital / Baylor
Houston, Texas, 77030
Riley Children's Hospital of Indiana
Indianapolis, Indiana, 46208
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19083
Primary Children's Hospital
Salt Lake City, Utah, 84116
About this study
Official title: 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.
Read the 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
- Being tested
- passive range of motion exercise therapy
- Keywords
- Norwood, hypoplastic left heart syndrome, single right ventricle, passive range-of-motion
- Medical subject headings
- Heart Defects, Congenital, Hypoplastic Left Heart Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
passive range of motion exercise therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Passive range-of-motion | Experimental | 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 Receives: Other: passive range of motion exercise therapy |
| Standard of care | No intervention | standard of care at study site |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight-for-age z-score
weight-for-age z-score
Measured: 4 months of age or superior cavopulmonary connection (SCPC) evaluation clinic visit, whichever comes first
Secondary outcomes (6)
length-for-age z-score
length-for-age z-score
Measured: 4 months of age or superior cavopulmonary connection (SCPC) evaluation clinic visit, whichever comes first
head circumference-for-age z-score
head circumference-for-age z-score
Measured: 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
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)
Measured: Post-operative day 21 or discharge, whichever comes first
Tests of Infant Motor Performance (TIMP)
Tests of Infant Motor Performance (TIMP)
Measured: Time of discharge from hospital following Norwood Procedure, approximately 3-4 weeks
Tests of Infant Motor Performance (TIMP)
Tests of Infant Motor Performance (TIMP)
Measured: 4 months of age or superior cavopulmonary connection (SCPC) evaluation clinic visit, whichever comes first
DXA
bone mineral density as measured by dual-energy X-ray absorptiometry (DXA) scan
Measured: 4 months of age or superior cavopulmonary connection (SCPC) evaluation clinic visit, whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start23 Feb 2021
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carelon Research
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04702373
- Sponsor's protocol ID
- PHN T4G RCT
- Acronym
- T4G RCT
- Status last verified
- Jul 2024
- First submitted
- 3 Dec 2020
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training in Exercise Activities and Motion for Growth: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04702373
- Acronym / sponsor ID
- T4G RCT / PHN T4G RCT
- Conditions
- Congenital Heart Disease
- Keywords
- Norwood, hypoplastic left heart syndrome, single right ventricle, passive range-of-motion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Carelon ResearchUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 23 Feb 2021 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 8 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Passive range-of-motion | Experimental | Other: passive range of motion exercise therapydaily 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 |
| Standard of care | No intervention | –standard of care at study site |
Who may qualify
- Ages
- Up to 35 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| passive range of motion exercise therapySystematic 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. | Other | Passive range-of-motion |
Primary outcome
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
6 secondary outcomes
length-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
Time frame: 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
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 frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing passive range of motion exercise therapy in people with Congenital Heart Disease, run by Carelon Research at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight-for-age z-score (time frame: 4 months of age or superior cavopulmonary connection (SCPC) evaluation clinic visit, whichever comes first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.