Single Ventricle PhysiologyT4GNCT01917084
Training in Exercise Activities and Motion for Growth
A study testing Passive range of motion (ROM) exercise in people with Single Ventricle Physiology, run by Carelon Research at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 30 days
- Conditions the study is for
- Single Ventricle Physiology
- What is being tested?
- Passive range of motion (ROM) exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2013to Dec 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 1 day to 30 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Hospitalized infants with SV physiology
- >37 weeks gestation
- <30 days of age
- Hemodynamically stable (as defined by the attending physician) after surgical or interventional palliation with closed sternum
- Parent or guardian willing to comply with protocol and provide written informed consent
Who cannot join
- Intrauterine growth restriction
- Chromosomal or recognizable phenotypic syndrome of non-cardiac congenital abnormalities associated with growth failure (for example Trisomy, Noonan or Turner syndromes)
- Unstable hemodynamics as defined by the attending physician
- Non-cardiac diagnosis associated with growth failure
- Severe neurologic injury resulting from stroke or intracranial hemorrhage confirmed by head CT/ MRI or cranial ultrasound
- Anticipated discharge within 14 days of screening
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Baylor College of Medicine - Texas Children's Hospital
Houston, Texas, 77030
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Utah Primary Children's Medical Center
Salt Lake City, Utah, 84132
About this study
Official title: Training in Exercise Activities and Motion for Growth (A Study Conducted by the Pediatric Heart Network)
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.
Read the 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
- Being tested
- Passive range of motion (ROM) exercise
- Keywords
- Passive range of motion, Single ventricle, Infants, Congenital heart disease
- Medical subject headings
- Univentricular Heart, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passive range of motion (ROM) exerciseOther
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
| Study group | Role | What they receive |
|---|---|---|
| Passive range of motion (ROM) exercise | Experimental | A 10 - 15 minute passive range of motion (ROM) exercise program will be administered daily during hospitalization for up to 21 days or until discharge (whichever comes first). Receives: Other: Passive range of motion (ROM) exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AEs) and Serious Adverse Events (SAEs) in a Passive ROM Exercise Program, Administered up to 21 Days After the Norwood Procedure, in Infants With Single Ventricle Physiology
- Number of adverse events (AE), of any type, occurring during and for one hour after the daily study intervention is concluded
- Number of AEs that are possibly or probably related to the intervention occurring during and for one hour after the daily study intervention is concluded
- Number of Serious Adverse Events (SAEs) possibly or probably related to the intervention occurring at any time during the 21 day intervention period
Measured: during the intervention and for one hour afterwards, daily up to 21 days
Feasibility of a Passive ROM Exercise Program, Administered up to 21 Days After the Norwood Procedure, in Infants With Single Ventricle Physiology
Percentage of days with high completion, medium completion, and low completion of the intervention:
- High completion is defined as >75% of the intervention
- Medium completion is defined as 50-75% of the intervention
- Low completion is defined as <50% of the intervention
Percentage of days with high/medium/low completion was then calculated across all participants and days
Measured: during intervention, up to 21 days
Number of Participants With Adverse Events (AEs) in a Passive ROM Exercise Program, Administered up to 21 Days After the Norwood Procedure, in Infants With Single Ventricle Physiology
- Number of participants with adverse events (AE), of any type, occurring during and for one hour after the daily study intervention is concluded
Measured: during the intervention and for one hour afterwards, daily up to 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2013 (estimated)
- Study startJun 2013
- Primary completionSep 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Single Ventricle PhysiologyStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 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
- Investigators
- Linda Lambert, MSN, c-FNP, Study chair, Utah Primary Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01917084
- Sponsor's protocol ID
- U10HL068270
- Other IDs
- U01HL068270
- Acronym
- T4G
- Status last verified
- Dec 2013
- First submitted
- 2 Aug 2013
- Last updated
- 20 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training in Exercise Activities and Motion for Growth (A Study Conducted by the Pediatric Heart Network)
- ClinicalTrials.gov ID
- NCT01917084
- Acronym / sponsor ID
- T4G / U10HL068270
- Conditions
- Single Ventricle Physiology
- Keywords
- Passive range of motion, Single ventricle, Infants, Congenital heart disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Carelon ResearchUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jun 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 6 Aug 2013 (estimated)
- Results
- Posted 19 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Passive range of motion (ROM) exercise | Experimental | Other: Passive range of motion (ROM) exerciseA 10 - 15 minute passive range of motion (ROM) exercise program will be administered daily during hospitalization for up to 21 days or until discharge (whichever comes first). |
Who may qualify
- Ages
- 1 day to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Hospitalized infants with SV physiology
- >37 weeks gestation
- <30 days of age
- Hemodynamically stable (as defined by the attending physician) after surgical or interventional palliation with closed sternum
- Parent or guardian willing to comply with protocol and provide written informed consent
Key exclusion criteria (6 listed)
- Intrauterine growth restriction
- Chromosomal or recognizable phenotypic syndrome of non-cardiac congenital abnormalities associated with growth failure (for example Trisomy, Noonan or Turner syndromes)
- Unstable hemodynamics as defined by the attending physician
- Non-cardiac diagnosis associated with growth failure
- Severe neurologic injury resulting from stroke or intracranial hemorrhage confirmed by head CT/ MRI or cranial ultrasound
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 (ROM) exerciseAfter 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 | Other | Passive range of motion (ROM) exercise |
Primary outcome
Adverse Events (AEs) and Serious Adverse Events (SAEs) in a Passive ROM Exercise Program, Administered up to 21 Days After the Norwood Procedure, in Infants With Single Ventricle Physiology
Time frame: during the intervention and for one hour afterwards, daily up to 21 days
* Number of adverse events (AE), of any type, occurring during and for one hour after the daily study intervention is concluded * Number of AEs that are possibly or probably related to the intervention occurring during and for one hour after the daily study intervention is concluded * Number of Serious Adverse Events (SAEs) possibly or probably related to the intervention occurring at any time during the 21 day intervention period
Feasibility of a Passive ROM Exercise Program, Administered up to 21 Days After the Norwood Procedure, in Infants With Single Ventricle Physiology
Time frame: during intervention, up to 21 days
Percentage of days with high completion, medium completion, and low completion of the intervention: * High completion is defined as >75% of the intervention * Medium completion is defined as 50-75% of the intervention * Low completion is defined as <50% of the intervention Percentage of days with high/medium/low completion was then calculated across all participants and days
Number of Participants With Adverse Events (AEs) in a Passive ROM Exercise Program, Administered up to 21 Days After the Norwood Procedure, in Infants With Single Ventricle Physiology
Time frame: during the intervention and for one hour afterwards, daily up to 21 days
• Number of participants with adverse events (AE), of any type, occurring during and for one hour after the daily study intervention is concluded
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Pediatric Heart NetworkLink provided by the sponsor.
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.
Linda Lambert, MSN, c-FNP study chair
Utah Primary Children's Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Passive range of motion (ROM) exercise in people with Single Ventricle Physiology, run by Carelon Research at 3 sites in United States.
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 6 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: finished, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Adverse Events (AEs) and Serious Adverse Events (SAEs) in a Passive ROM Exercise Program, Administered up to 21 Days After the Norwood Procedure, in Infants With Single Ventricle Physiology (time frame: during the intervention and for one hour afterwards, daily up to 21 days). The study lists 3 primary outcomes in all. 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 20 Feb 2025; AzTrials last refreshed its copy on 29 Oct 2026.