Refractory Respiratory Failure
Conditions
Brief summary
Patients undergoing extracorporeal membrane oxygenation (ECMO) are at high risk for deconditioning and functional decline. The primary aim of this study is to assess the functional impact of leg exercise during the pre-ambulation phase in patients undergoing ECMO.
Detailed description
The investigators are conducting this study to explore the impact of closed-chain leg exercise in individuals undergoing ECMO. Aim 1: To determine if closed-chain leg exercise decreases the time to initial ambulation. The investgators hypothesize that adding leg exercise will decrease time to ambulation. Aim 2: To determine the impact of closed chain leg exercise on functional ability. The investigators hypothesize that adding leg exercise will improve functional outcomes when added to an existing early mobilization program. Aim 3: To determine the effect of closed chain leg exercise on hospital outcomes. The investigators hypothesize that hospital related outcomes will improve when leg exercise is added to an existing early mobilization program.
Interventions
OTHEROpen-Chain Leg Exercise
Individuals in the open-chain group will progress through standard mobility progression.
DEVICEClosed-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.
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
24 total subjects will be recruited; 12 per group. Approximately 3-5 patients are admitted to UMMC each month who are undergoing ECMO and could be considered for study inclusion.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients with refractory respiratory failure undergoing ECMO at the University of Minnesota Medical Center, Fairview. * Able to follow 3 out of 3 one-step commands via protocol. * Active Inpatient Physical Therapy Referral. * ECMO delivery is veno-venous with internal jugular catheter.
Exclusion criteria
* Femoral catheter of any kind present * Veno-arterial ECMO set-up * Sedation such that self-consent is not attainable * Medical instability, as determined by primary critical care physician
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Ambulation | Baseline, to day 45 if applicable | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 2 |
| 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. | 2 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
Baseline characteristics
| Characteristic | Closed-Chain Leg Exercise | Total | Open-Chain Leg Exercise |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 4 Participants | 2 Participants |
| Age, Continuous | 52.5 years | 45.25 years | 38 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 3 Participants | 1 Participants |
| Region of Enrollment United States | 2 participants | 4 participants | 2 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 2 Participants | 4 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 1 / 2 |
| other Total, other adverse events | 0 / 2 | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 | 0 / 2 |
Outcome results
Primary
Time to Ambulation
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.
Time frame: Baseline, to day 45 if applicable
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Open-Chain Leg Exercise | Time to Ambulation | 14.5 days |
| Closed-Chain Leg Exercise | Time to Ambulation | 15 days |