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Leg Exercise During ECMO

University of Minnesota (UMN) logo

University of Minnesota (UMN)

Status

Completed

Conditions

Refractory Respiratory Failure

Treatments

Device: Closed-Chain Leg Exercise
Other: Open-Chain Leg Exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT03135210
1703M10081

Details and patient eligibility

About

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.

Full 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.

Enrollment

4 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

4 participants in 2 patient groups

Open-Chain Leg Exercise
Active Comparator group
Description:
Individuals in the open-chain group will progress through standard mobility progression.
Treatment:
Other: Open-Chain Leg Exercise
Closed-Chain Leg Exercise
Experimental group
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.
Treatment:
Device: Closed-Chain Leg Exercise

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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