Leg Exercise During ECMO

Refractory Respiratory Failure Clinical Trial

— ECMO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03135210
• Other study ID #: 1703M10081
• Status: Completed
• Phase: N/A
• Start date: November 13, 2017
• Est. completion date: February 1, 2020

Study information

• Verified date: February 2021
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: February 1, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Refractory Respiratory Failure
• Respiratory Insufficiency

Intervention

Other:
• Open-Chain Leg Exercise
Individuals in the open-chain group will progress through standard mobility progression.

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.

Locations

Country	Name	City	State
United States	University of Minnesota Medical Center, Fairview	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline, to day 45 if applicable