Leg Exercise During ECMO

Not Applicable

Completed

• Conditions: Refractory Respiratory Failure
• Interventions: Device: Closed-Chain Leg Exercise; Other: Open-Chain Leg Exercise

• Registration Number: NCT03135210
• Lead Sponsor: University of Minnesota

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 Timeline

• Study First Submitted: 2017-04-21
• Study First Submitted QC: 2017-04-25
• Study First Posted: 2017-05-01
• Study Start: 2017-11-13
• Primary Completion: 2020-02-01
• Study Completion: 2020-02-01
• Results First Submitted: 2021-01-13
• Status Verified: 2021-02
• Results First Submitted QC: 2021-02-03
• Last Update Submitted: 2021-02-03
• Results First Posted: 2021-02-21
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Closed-Chain Leg Exercise	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.
Open-Chain Leg Exercise	Open-Chain Leg Exercise	Individuals in the open-chain group will progress through standard mobility progression.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Minnesota Medical Center, Fairview; 🇺🇸 Minneapolis, Minnesota, United States