The Impact of Lower Extremity Weight-Bearing Leg Exercise During the Pre-Ambulation Phase of Individuals Undergoing Extracorporeal Membrane Oxygenation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Minnesota
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- Time to Ambulation
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Open-Chain Leg Exercise
Individuals in the open-chain group will progress through standard mobility progression.
Intervention: Open-Chain Leg Exercise (Other)
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.
Intervention: Closed-Chain Leg Exercise (Device)
Outcomes
Primary Outcomes
Time to Ambulation
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported