NCT03554811

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Community Health System · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2020-01-01
• Primary completion: 2022-12-31
• Completion: 2023-12-31
• First posted: 2018-06-13
• Last updated: 2021-08-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study