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

Community Regional Medical Center

Status: Unknown

Conditions: ICU Acquired Weakness

Treatments: Device: Functional electrical stimulation assisted supine cycling (FESC); Other: Conventional early exercise and mobility interventions

Study type: Interventional

Funder types: Other

Identifiers

NCT03554811

2018015

Details and patient eligibility

About

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.

Enrollment: 32 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥ 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)

Exclusion criteria

• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 2 patient groups

Functional electrical stimulation assisted supine cycling

Experimental group

Description:

Patients will start functional electrical stimulation assisted supine cycling (FESC) within 48 hours of ICU admission and will undergo up to 1 hour of supine cycling daily, 5 days per week for 28 days, or until discharge from ICU.

Treatment:

Device: Functional electrical stimulation assisted supine cycling (FESC)

Other: Conventional early exercise and mobility interventions

Conventional early exercise and mobility interventions

Active Comparator group

Description:

Patients will undergo standard ICU exercise and mobility interventions.

Treatment:

Other: Conventional early exercise and mobility interventions