CompletedNot Applicable

Training in Exercise Activities and Motion for Growth

United States20 participantsStarted 2013-06

Plain-language 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.

Who can participate

Age range

1 Day – 30 Days

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 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

Timeframe: 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

Timeframe: during the intervention and for one hour afterwards, daily up to 21 days

Trial details

NCT IDNCT01917084

SponsorCarelon Research

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-09

Results submitted2018-02-01

View on ClinicalTrials.gov More Single Ventricle Physiology trials

Who can participate

Age range

1 Day – 30 Days

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: 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

Timeframe: 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

Timeframe: during the intervention and for one hour afterwards, daily up to 21 days