Trial Outcomes & Findings for Leg Exercise During ECMO (NCT NCT03135210)
NCT ID: NCT03135210
Last Updated: 2021-02-21
Results Overview
Time to ambulation is measured as the number of days required for the participant to regain the ability to walk without the need for any kind of assistance. The unit of measure is days.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
4 participants
Primary outcome timeframe
Baseline, to day 45 if applicable
Results posted on
2021-02-21
Participant Flow
Participant milestones
| Measure |
Open-Chain Leg Exercise
Individuals in the open-chain group will progress through standard mobility progression.
Open-Chain Leg Exercise: Individuals in the open-chain group will progress through standard mobility progression.
|
Closed-Chain Leg Exercise
Individuals in the closed-chain group will progress through standard mobility exercises with the addition of closed-chain leg exercises using the MOVEO platform.
Closed-Chain Leg Exercise: Individuals in the closed-chain group will progress through standard mobility exercises with the addition of closed-chain leg exercises using the MOVEO platform.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
|
Overall Study
COMPLETED
|
2
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Open-Chain Leg Exercise
Individuals in the open-chain group will progress through standard mobility progression.
Open-Chain Leg Exercise: Individuals in the open-chain group will progress through standard mobility progression.
|
Closed-Chain Leg Exercise
Individuals in the closed-chain group will progress through standard mobility exercises with the addition of closed-chain leg exercises using the MOVEO platform.
Closed-Chain Leg Exercise: Individuals in the closed-chain group will progress through standard mobility exercises with the addition of closed-chain leg exercises using the MOVEO platform.
|
|---|---|---|
|
Overall Study
Death
|
0
|
1
|
Baseline Characteristics
Leg Exercise During ECMO
Baseline characteristics by cohort
| Measure |
Open-Chain Leg Exercise
n=2 Participants
Individuals in the open-chain group will progress through standard mobility progression.
Open-Chain Leg Exercise: Individuals in the open-chain group will progress through standard mobility progression.
|
Closed-Chain Leg Exercise
n=2 Participants
Individuals in the closed-chain group will progress through standard mobility exercises with the addition of closed-chain leg exercises using the MOVEO platform.
Closed-Chain Leg Exercise: Individuals in the closed-chain group will progress through standard mobility exercises with the addition of closed-chain leg exercises using the MOVEO platform.
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
38 years
n=99 Participants
|
52.5 years
n=107 Participants
|
45.25 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
4 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, to day 45 if applicablePopulation: One participant in closed-chain leg exercise group expired after signing the consent form. Baseline data for this participant is included in the baseline characteristics section. Interventional data was not collected for this participant. All participants for whom outcome measure was collected are included in this analysis.
Time to ambulation is measured as the number of days required for the participant to regain the ability to walk without the need for any kind of assistance. The unit of measure is days.
Outcome measures
| Measure |
Open-Chain Leg Exercise
n=2 Participants
Individuals in the open-chain group will progress through standard mobility progression.
Open-Chain Leg Exercise: Individuals in the open-chain group will progress through standard mobility progression.
|
Closed-Chain Leg Exercise
n=1 Participants
Individuals in the closed-chain group will progress through standard mobility exercises with the addition of closed-chain leg exercises using the MOVEO platform.
Closed-Chain Leg Exercise: Individuals in the closed-chain group will progress through standard mobility exercises with the addition of closed-chain leg exercises using the MOVEO platform.
|
|---|---|---|
|
Time to Ambulation
|
14.5 days
Interval 11.0 to 18.0
|
15 days
Interval 15.0 to 15.0
|
Adverse Events
Open-Chain Leg Exercise
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Closed-Chain Leg Exercise
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place