Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Fresno, California
Dates
study started
estimated completion

Description

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.

Official Title

Early Rehabilitation Using Functional Electrical Stimulation Assisted Supine Cycling Effect on Muscle Mass, Strength, Biomarkers, and Functional Outcomes as Compared With Conventional Exercise and Early Mobilization Alone in Critically Ill Patients in the Intensive Care Unit

Keywords

ICU Acquired Weakness Functional electrical stimulation assisted supine cycling (FESC) Functional electrical stimulation assisted supine cycling

Eligibility

You can join if…

Open to people ages 18 years and up

  • ≥ 18 years of age
  • Admitted to the ICU with a predicted ICU length of stay ≥ 4 days
  • Expected to survive the ICU stay
  • Expected to receive mechanical ventilation > 48 hours
  • Able to perform physical outcome measures pre-morbidly (with or without an assisted device)

You CAN'T join if...

  • Proven or suspected neuromuscular weakness affecting the legs (eg- stroke or Guillain-Barré syndrome)
  • Lower limb amputation(s)
  • Assessed by medical staff as approaching imminent death or withdrawal of medical treatment within 36 hours
  • Pregnancy
  • Body mass index > 40
  • Presence of external fixator or superficial metal in lower limb
  • Open wounds or skin abrasions at electrode application points
  • Presence of pacemaker or implanted defibrillator
  • Transferred from another ICU after >48 hours of consecutive mechanical ventilation
  • Lower limb malignancy
  • Pre-existing intellectual disability or cognitive impairment limiting the ability to accurately follow instructions
  • Body habitus unable to fit the bike
  • Palliative goals of care
  • Unable to participate in FESC within 48 hours of ICU admission due to logistic reasons or due to failure in daily screening for participation

Location

  • Community Regional Medical Center accepting new patients
    Fresno California 93721 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Fresno Community Hospital and Medical Center
ID
NCT03554811
Study Type
Interventional
Last Updated