Trial Outcomes & Findings for Training in Exercise Activities and Motion for Growth (NCT NCT01917084)
NCT ID: NCT01917084
Last Updated: 2025-02-20
Results Overview
* 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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
during the intervention and for one hour afterwards, daily up to 21 days
Results posted on
2025-02-20
Participant Flow
Participant milestones
| Measure |
Passive Range of Motion (ROM) Exercise
A 10 - 15 minute passive range of motion (ROM) exercise program was administered daily during hospitalization for up to 21 days or until discharge (whichever came first).
Passive range of motion (ROM) exercise: After their Norwood surgery, stable subjects underwent passive ROM exercise therapy for up to 21 consecutive days or until hospital discharge, whichever came first. Subjects completed the study after their anthropometric measurements were collected at 3 months of age
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Passive Range of Motion (ROM) Exercise
A 10 - 15 minute passive range of motion (ROM) exercise program was administered daily during hospitalization for up to 21 days or until discharge (whichever came first).
Passive range of motion (ROM) exercise: After their Norwood surgery, stable subjects underwent passive ROM exercise therapy for up to 21 consecutive days or until hospital discharge, whichever came first. Subjects completed the study after their anthropometric measurements were collected at 3 months of age
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|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Training in Exercise Activities and Motion for Growth
Baseline characteristics by cohort
| Measure |
Passive Range of Motion (ROM) Exercise
n=20 Participants
A 10 - 15 minute passive range of motion (ROM) exercise program was administered daily during hospitalization for up to 21 days or until discharge (whichever came first).
Passive range of motion (ROM) exercise: After their Norwood surgery, stable subjects underwent passive ROM exercise therapy for up to 21 consecutive days or until hospital discharge, whichever came first. Subjects completed the study after their anthropometric measurements were collected at 3 months of age
|
|---|---|
|
Age, Continuous
|
8 days
n=99 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Passive Range of Motion (ROM) Exercise
n=20 Participants
A 10 - 15 minute passive range of motion (ROM) exercise program was administered daily during hospitalization for up to 21 days or until discharge (whichever came first).
Passive range of motion (ROM) exercise: After their Norwood surgery, stable subjects underwent passive ROM exercise therapy for up to 21 consecutive days or until hospital discharge, whichever came first. Subjects completed the study after their anthropometric measurements were collected at 3 months of age
|
|---|---|
|
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
|
11 events
|
|
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 AEs that are possibly or probably relate
|
1 events
|
|
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 SAEs possibly or probably related
|
0 events
|
PRIMARY outcome
Timeframe: during intervention, up to 21 daysPercentage 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
Outcome measures
| Measure |
Passive Range of Motion (ROM) Exercise
n=20 Participants
A 10 - 15 minute passive range of motion (ROM) exercise program was administered daily during hospitalization for up to 21 days or until discharge (whichever came first).
Passive range of motion (ROM) exercise: After their Norwood surgery, stable subjects underwent passive ROM exercise therapy for up to 21 consecutive days or until hospital discharge, whichever came first. Subjects completed the study after their anthropometric measurements were collected at 3 months of age
|
|---|---|
|
Feasibility of a Passive ROM Exercise Program, Administered up to 21 Days After the Norwood Procedure, in Infants With Single Ventricle Physiology
High completion
|
88 percent of days
|
|
Feasibility of a Passive ROM Exercise Program, Administered up to 21 Days After the Norwood Procedure, in Infants With Single Ventricle Physiology
Medium completion
|
2 percent of days
|
|
Feasibility of a Passive ROM Exercise Program, Administered up to 21 Days After the Norwood Procedure, in Infants With Single Ventricle Physiology
Low completion
|
10 percent of days
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Passive Range of Motion (ROM) Exercise
n=20 Participants
A 10 - 15 minute passive range of motion (ROM) exercise program was administered daily during hospitalization for up to 21 days or until discharge (whichever came first).
Passive range of motion (ROM) exercise: After their Norwood surgery, stable subjects underwent passive ROM exercise therapy for up to 21 consecutive days or until hospital discharge, whichever came first. Subjects completed the study after their anthropometric measurements were collected at 3 months of age
|
|---|---|
|
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
|
6 participants
|
Adverse Events
Passive Range of Motion (ROM) Exercise
Serious events: 3 serious events
Other events: 5 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Passive Range of Motion (ROM) Exercise
n=20 participants at risk
A 10 - 15 minute passive range of motion (ROM) exercise program was administered daily during hospitalization for up to 21 days or until discharge (whichever came first).
Passive range of motion (ROM) exercise: After their Norwood surgery, stable subjects underwent passive ROM exercise therapy for up to 21 consecutive days or until hospital discharge, whichever came first. Subjects completed the study after their anthropometric measurements were collected at 3 months of age
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|---|---|
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Cardiac disorders
cardiac arrest
|
5.0%
1/20 • Number of events 1 • through final (pre-Stage II palliation) study visit, which occurred at a different age and time from initial surgery for each participant, typically at 3-6 months of age
|
|
Respiratory, thoracic and mediastinal disorders
hypercarbia secondary to oversedation
|
5.0%
1/20 • Number of events 1 • through final (pre-Stage II palliation) study visit, which occurred at a different age and time from initial surgery for each participant, typically at 3-6 months of age
|
|
Respiratory, thoracic and mediastinal disorders
laryngomalacia
|
5.0%
1/20 • Number of events 1 • through final (pre-Stage II palliation) study visit, which occurred at a different age and time from initial surgery for each participant, typically at 3-6 months of age
|
|
Respiratory, thoracic and mediastinal disorders
respiratory distress with hypercapnia
|
5.0%
1/20 • Number of events 1 • through final (pre-Stage II palliation) study visit, which occurred at a different age and time from initial surgery for each participant, typically at 3-6 months of age
|
Other adverse events
| Measure |
Passive Range of Motion (ROM) Exercise
n=20 participants at risk
A 10 - 15 minute passive range of motion (ROM) exercise program was administered daily during hospitalization for up to 21 days or until discharge (whichever came first).
Passive range of motion (ROM) exercise: After their Norwood surgery, stable subjects underwent passive ROM exercise therapy for up to 21 consecutive days or until hospital discharge, whichever came first. Subjects completed the study after their anthropometric measurements were collected at 3 months of age
|
|---|---|
|
Cardiac disorders
Intermittent Sinus Tachycardia
|
5.0%
1/20 • Number of events 1 • through final (pre-Stage II palliation) study visit, which occurred at a different age and time from initial surgery for each participant, typically at 3-6 months of age
|
|
General disorders
Poor weight gain
|
5.0%
1/20 • Number of events 1 • through final (pre-Stage II palliation) study visit, which occurred at a different age and time from initial surgery for each participant, typically at 3-6 months of age
|
|
Cardiac disorders
Supraventricular tachycardia
|
5.0%
1/20 • Number of events 1 • through final (pre-Stage II palliation) study visit, which occurred at a different age and time from initial surgery for each participant, typically at 3-6 months of age
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnic with feeds
|
5.0%
1/20 • Number of events 1 • through final (pre-Stage II palliation) study visit, which occurred at a different age and time from initial surgery for each participant, typically at 3-6 months of age
|
|
Respiratory, thoracic and mediastinal disorders
increased work of breathing with feeds
|
5.0%
1/20 • Number of events 1 • through final (pre-Stage II palliation) study visit, which occurred at a different age and time from initial surgery for each participant, typically at 3-6 months of age
|
|
Skin and subcutaneous tissue disorders
midsternal wound dehiscence
|
5.0%
1/20 • Number of events 1 • through final (pre-Stage II palliation) study visit, which occurred at a different age and time from initial surgery for each participant, typically at 3-6 months of age
|
|
Cardiac disorders
ventricular bigeminy
|
5.0%
1/20 • Number of events 1 • through final (pre-Stage II palliation) study visit, which occurred at a different age and time from initial surgery for each participant, typically at 3-6 months of age
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place