Back to resultsLeg Exercise During ECMO (ECMO)
Primary Purpose
Refractory Respiratory Failure
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Open-Chain Leg Exercise
Closed-Chain Leg Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Refractory Respiratory Failure
Eligibility Criteria
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
Sites / Locations
- University of Minnesota Medical Center, Fairview
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Open-Chain Leg Exercise
Closed-Chain Leg Exercise
Arm Description
Individuals in the open-chain group will progress through standard mobility progression.
Individuals in the closed-chain group will progress through standard mobility exercises with the addition of closed-chain leg exercises using the MOVEO platform.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03135210
First Posted
April 21, 2017
Last Updated
February 3, 2021
Sponsor
University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT03135210
Brief Title
Leg Exercise During ECMO
Acronym
ECMO
Official Title
The Impact of Lower Extremity Weight-Bearing Leg Exercise During the Pre-Ambulation Phase of Individuals Undergoing Extracorporeal Membrane Oxygenation
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
November 13, 2017 (Actual)
Primary Completion Date
February 1, 2020 (Actual)
Study Completion Date
February 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Respiratory Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Open-Chain Leg Exercise
Arm Type
Active Comparator
Arm Description
Individuals in the open-chain group will progress through standard mobility progression.
Arm Title
Closed-Chain Leg Exercise
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
Open-Chain Leg Exercise
Intervention Description
Individuals in the open-chain group will progress through standard mobility progression.
Intervention Type
Device
Intervention Name(s)
Closed-Chain Leg Exercise
Other Intervention Name(s)
Moveo Platform
Intervention Description
Individuals in the closed-chain group will progress through standard mobility exercises with the addition of closed-chain leg exercises using the MOVEO platform.
Primary Outcome Measure Information:
Title
Time to Ambulation
Description
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.
Time Frame
Baseline, to day 45 if applicable
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amanda N LaLonde, DPT
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota Medical Center, Fairview
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Leg Exercise During ECMO
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