Leg Exercise During ECMO

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Impact of Lower Extremity Weight-Bearing Leg Exercise During the Pre-Ambulation Phase of Individuals Undergoing Extracorporeal Membrane Oxygenation

Conditions
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Refractory Respiratory Failure

Intervention / Treatment
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* Other: Open-Chain Leg Exercise
* Device: Closed-Chain Leg Exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Open-Chain Leg Exercise<br>Individuals in the open-chain group will progress through standard mobility progression. | Other: Open-Chain Leg Exercise<br>* Individuals in the open-chain group will progress through standard mobility progression.<br>|
| Experimental: Closed-Chain Leg Exercise<br>Individuals in the closed-chain group will progress through standard mobility exercises with the addition of closed-chain leg exercises using the MOVEO platform. | Device: Closed-Chain Leg Exercise<br>* Individuals in the closed-chain group will progress through standard mobility exercises with the addition of closed-chain leg exercises using the MOVEO platform.<br>* Other names: Moveo Platform;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, to day 45 if applicable |