Early Rehabilitation Using Functional Electrical Stimulation Assisted Supine Cycling in the Intensive Care Unit
Status unconfirmed · Not applicable
Conditions studied: ICU Acquired Weakness
In brief
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.
Key facts
- Study ID
- NCT03554811
- Run by
- Community Health System
- People needed
- 32
- Starts
- 2020-01-01
- Expected to finish
- 2023-12-31
- Last updated by the study team
- 2021-08-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ≥ 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 may not qualify 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
Where it is running
- Community Regional Medical Center — Fresno, California, United States (enrolling)
Full record on ClinicalTrials.gov
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