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Early Rehabilitation Using Functional Electrical Stimulation Assisted Supine Cycling in the Intensive Care Unit

NCT03554811 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2021-08-20

No results posted yet for this study

Summary

Critically ill patients in the intensive care unit are known to lose muscle mass and function at a rapid rate. Currently, there is a global recognition and shift in the ICU culture to reduce sedation and encourage exercise and mobilization early during the ICU stay. Functional stimulation assisted supine cycling can be applied to patients in the bed and does not require patient participation. This study seeks to evaluate the effect of conventional exercise and early mobilization in combination with functional stimulation assisted supine cycling applied early during the ICU on muscle mass, strength, and physical function, as well as patient-reported disability as compared to conventional exercise and early mobilization alone.

Conditions

  • ICU Acquired Weakness

Interventions

DEVICE

Functional electrical stimulation assisted supine cycling (FESC)

A supine cycle ergometer attached to a six-channel stimulator will be used for FESC. Surface electrodes will be applied to the hamstrings, quadriceps, and calf muscles on both legs. Muscles will be stimulated at specific stages throughout the cycling phase. Each session will start with a 1 minute motor-driven passive cycling warm-up at a rate of 20 revolutions per minute. Patients will continue with passive, active-assisted, or active cycling, according to their level of participation. If the patients stop cycling actively, the ergometer will revert to passive cycling.

OTHER

Conventional early exercise and mobility interventions

These interventions will be based on the patient's alertness and medical stability, and includes activities to maintain or increase limb range of motion and strength, in and out of bed mobility, sit to stand, and transfer training, as well as assisted ambulation.

Sponsors & Collaborators

  • Western University of Health Sciences

    collaborator OTHER

  • Fresno Community Hospital and Medical Center

    lead OTHER

Principal Investigators

  • Paul D Smith, PT, DPT · Community Medical Centers

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2022-12-31
Completion
2023-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03554811 on ClinicalTrials.gov