Leg Exercise During ECMO

NCT03135210 | Completed Results FDA Device

• 1 other identifier: 1703M10081
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Refractory Respiratory Failure

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Open-Chain Leg Exercise

ACTIVE COMPARATOR

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

Other: Open-Chain Leg Exercise

Closed-Chain Leg Exercise

EXPERIMENTAL

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

Interventions

Open-Chain Leg Exercise OTHER

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

Open-Chain Leg Exercise

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.

Also known as: Moveo Platform

Closed-Chain Leg Exercise

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota Medical Center, Fairview

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Results Point of Contact

• Title: Amanda Sharp
• Organization: University of Minnesota

sharp@umn.edu

(612) 626-4691

Study Officials

• Amanda N LaLonde, DPT

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 21, 2017
• First Posted: May 1, 2017
• Study Start: November 13, 2017
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: February 21, 2021
• Results First Posted: February 21, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)