Leg Exercise During ECMO (ECMO)

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

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.

Study Overview

• Status: Completed
• Conditions: Refractory Respiratory Failure
• Intervention / Treatment: Other: Open-Chain Leg Exercise; Device: Closed-Chain Leg Exercise

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 Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota Medical Center, Fairview

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Open-Chain Leg Exercise; Individuals in the open-chain group will progress through standard mobility progression.	Other: Open-Chain Leg Exercise; Individuals in the open-chain group will progress through standard mobility progression.
Experimental: 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.	Device: 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.; Other Names: Moveo Platform

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Amanda N LaLonde, DPT, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2017
• Primary Completion (Actual): February 1, 2020
• Study Completion (Actual): February 1, 2020

Study Registration Dates

• First Submitted: April 21, 2017
• First Submitted That Met QC Criteria: April 25, 2017
• First Posted (Actual): May 1, 2017

Study Record Updates

• Last Update Posted (Actual): February 21, 2021
• Last Update Submitted That Met QC Criteria: February 3, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: 1703M10081

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No