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Completed

NCT Number: NCT03135210

Leg Exercise During ECMO

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.

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Key information

Conditions

Refractory Respiratory Failure Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota Medical Center, Fairview

Minneapolis, Minnesota, 55455, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Open-Chain Leg Exercise

Other

Individuals in the open-chain group will progress through standard mobility progression.

Closed-Chain Leg Exercise

Device

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

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

Acronym: ECMO

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
May 1, 2017
Registry last updated
Feb 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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